BoC
Book of Competence
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Package Integrity
WARNING This document may not be copied, transferred, or modified without the prior written consent of Tetra Pak Carton Ambient S.p.A.
Doc. No. BoC-2712261-0101
and all Tetra Pak products are trademarks belonging to the Tetra Pak Group. This document was produced by: Sara Davolio and Monica Malagoli Tetra Pak Carton Ambient Via Delfini 1 41100 MODENA Italy Additional copies can be requested to the authors or downloaded from the TPCA Package Integrity webpage. When ordering additional copies, always provide the document number. It is printed on the front cover and in the footer on each page of the manual. Doc. No. BoC-2712261-0101 Issue 2004-11
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All rights reserved. No part of this document may be reproduced or copied in any form or by any means without written permission from Tetra Pak Carton Ambient
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Copyright © 2004 Tetra Pak Group
i Introduction ii Safety Precautions
BoC
iii Getting to know the Package
Book of Competence
1 Transversal Seal (TS)
Package Integrity
2 Longitudinal Seal (LS/SA)
4 Package Integrity TechPub_2614345_0103 - BoC_2712261_0101_fro.fm
5 Package Forming Appendix A: Flowcharts and Troubleshooting Appendix B: Tools and Chemicals Appendix C: Data Record
Doc. No. BoC-2712261-0101 Issue 2004-11
Tetra Pak Carton Ambient
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3 Opening Devices
Major inputs have been received from FiSQA and System Specialists. Among the contributions, a special thanks goes to Kevin, Reinhard Shigeru Okada and Hitoshi Matsumoto for constant inputs and support. Sara Davolio Monica Malagoli
November 2004
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This Book of Competence - Package Integrity is based on the state of the art spread in the Company on Package Integrity Competence.
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Foreword
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i Introduction
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i Introduction
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This chapter contains basic information about this manual.
Table of Contents
i Introduction
Personnel Requirements . . . . . . . . . . . . . . . . . . . i - 5 Qualified Personnel . . . . . . . . . . . . . . . . . . . . . . . . . i - 5 Specialized Personnel . . . . . . . . . . . . . . . . . . . . . . . i - 5
How to use this book . . . . . . . . . . . . . . . . . . . . . . i - 6 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i - 6 Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i - 8 A: General Information. . . . . . . . . . . . . . . . . . . . . . . . . . i - 8 B: Procedures, Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . i - 8
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Abbreviations and Terminology . . . . . . . . . . . . . . i - 9 Reference documents . . . . . . . . . . . . . . . . . . . . . i - 11 Manual Information . . . . . . . . . . . . . . . . . . . . . . . i - 12 Page Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i - 12 Page Numbering. . . . . . . . . . . . . . . . . . . . . . . . . . . i - 13 Typographical Conventions . . . . . . . . . . . . . . . . . i - 13 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i - 13
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C: Appendix, additional material. . . . . . . . . . . . . . . . . . i - 8
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i Introduction
i Introduction
Personnel Requirements
Personnel Requirements Note! Personnel includes all persons working with Package Integrity methods and Equipment. The methods described in this Book of Competence must be performed by qualified or specialised personnel. The level of expertise required is mentioned at the beginning of each method. Training is available at TTC.
Qualified Personnel Qualified means that personnel have received specific training on Package Integrity QC Methods. This level of education is required in most of the methods.
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Specialized personnel are chemists, laboratory technicians which have a professional knowledge of reagents and laboratory techniques. This level of education is required for methods which imply the use of chemicals and solvents. FiSQA officers and Technical Service Specialists are considered specialized personnel once specific training has been taken. CAUTION Always handle the chemicals carefully and wear protective goggles and gloves. Dispose of chemicals in the manner prescribed by current regulations.
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Specialized Personnel
i Introduction
How to use this book
How to use this book Purpose This book is mainly addressed to: • FiSQA Officers • Technical Instructors • System Specialists • •
Senior Tetra Pak Field Service Engineers Senior Technical Support Staff.
The aim is to give clear instructions on how to evaluate the integrity of the TPCA packages.
Package Integrity Methods must be performed on regular basis during and after Production, to monitor the quality of the packages and the performance of the filling machines. Specific checks must be carried out for special products (e.g. products with fibres) and opening devices (PullTab, FlexiCap). A defect in the package microbiological barrier does not necessarily imply a microbiological problem, since the following conditions must take place in addition: • • •
presence of microorganisms in the package surrounding; favourable environmental conditions; period of time in which they grow and spoil the product.
On the other hand, when visible integrity problems such as leakage during transportation or package blowing occur, we are sure that the package is defective, and that the packages close to it might be affected by the same defect. In this case, a troubleshooting procedure is needed to investigate the causes of the proven unsterility. Package Integrity Methods can be grouped into a limited number of procedures as follows, according to the kind of investigation needed. The Appendix A: Flowcharts and Troubleshooting section includes a step by step description of each procedure. (Cont'd)
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A package showing product spills is easy to detect. Less visible defects that jeopardise the protective function of the package can be detected following the correct procedures described in this manual. Package Integrity Quality Methods are systematic, precise and destructive. Samples are no longer available after evaluation, hence the importance of performing them correctly.
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TPCA packages contain and protect the packed product from filling to recommended consumption, at ambient temperature.
i Introduction
How to use this book
(Cont'd) QC checks during Production These are checks carried out by the operator during production. They are aimed at evaluating the appearance of the package (shape and design, flap sealing, surfaces), the fulfilment of legal requirements (date printing, weight) and the quality of the package sealing (Tranversal Sealing and Longitudinal Sealing tear down). The machine settings (temperatures, pressures, weight and design control settings) can be corrected accordingly, in order to ensure a good production.
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Laboratory QC checks after Production These checks must be carried out on a regular basis by qualified personnel, in an area appropriately equipped. They are destructive, and imply the use of chemicals or specific laboratory tools. The data are analyzed statistically, in order to evaluate the incidence of defective packages in a population. Testing products with fibres Products containing more than 5% of citrus fibres can compromise the integrity of the TS as fibres can be trapped in the sealing creating channels to the outside of the package. A specific procedure must be followed to investigate the performance of the product. Troubleshooting When a production proves defective due to leakages or package blowing, the causes of the unsterility must be investigated. In this case, the analysis is not statistical, but aims at identifying the origin of specific defects. The samples must be prepared so that the package is not cut apart but analyzed as a whole to be able to see if package integrity is the reason for the unsterility. It is advisable to test a tray of packages where one or more samples are suspected to be defective, so that the overall behaviour of the Production can be assessed. The test methods are applied in a defined sequence aiming to get an unequivocal answer if package integrity is the main cause for the unsterility in terms of: • • •
Loss of microbiological barrier (corners, K-cracks, fin tears) PullTab Longitudinal Sealing
•
Trasversal Sealing
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Note! This book does not include instructions reported on OM, MM manuals and TTC brochures, such as machine setting procedures or volume dependent values. Refer to these manuals to integrate this kind of information.
i Introduction
How to use this book
Structure The content of this book is divided into three main groups. They are described below.
A: General Information
B
ii Safety Precautions
iii Getting to know the package
1 Transversal Seal (TS) tests (MTD 1201 - 1208 - 1211)
2 Longitudinal Seal (LS/SA) test (MTD 1202)
3 Opening Devices test (MTD 1211) 4 Package Integrity tests (MTD 1203 - 1204 - 1207)
5 Package Forming tests (OM as a reference)
These chapters provide general information, important safety information, and overview of packaging material, strips and package terminology. These chapters include: • Introduction • Safety Precautions • Getting to know the package.
B: Procedures, Tests These chapters provide a sequence of instructions for the tests to be performed on the package. These chapters include: • Transversal Seal • Longitudinal Seal • • •
Opening Devices Package Integrity Package Forming.
C: Appendix, additional material
C Flowcharts and troubleshooting
Tools and Chemicals
Data recording sheets
These chapters provide information about additional material used to carry out the tests and record the results. These chapters include: • Flowcharts and troubleshooting • •
i - 8 (14)
Tools and Chemicals Data recording sheets.
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i Introduction
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A
i Introduction
Abbreviations and Terminology
Abbreviation
Meaning/Definition
Al-foil
Aluminium foil
Ammeter
Instrument measuring electric current in amperes
ASU
Automatic Splicing Unit
B
Base (package shape)
Blocked Seal
Cold Seal
DE
Distribution Equipment
DIMC
Direct Injection Moulding Cap
FiSQA
Field Service Quality Assurance
FlexiCap
Flexible Cap
HDPE
High Density Polyethylene
IH
Induction Heating
LLDPE
Linear Low Density Polyethylene
LH
Left Hand
LS
Longitudinal Sealing
max
Maximum
min
Minimum
MM
Maintenance Manual
mPE
LLDPE syntetized by metallocene catalyst process
MTD
Method
OK
Optional Kit
OE
Optional Equipment
OM
Operation Manual
PE
Polyethylene
Plastic Lumps
Hard residue of plastic that hardens out of the TS sealing area. They might be referred as “walling” (USA terminology)
PLH
Pre Laminated Hole
PM
Packaging Material
PT
PullTab
QA
Quality Assurance
QC
Quality Control
RH
Right Hand
S
Slim (package shape)
SA
Strip Applicator
Notes
Technique used in FlexiCap application It uses DIMC technology
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Abbreviations and Terminology
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i Introduction
Abbreviations and Terminology
Sealing Monitoring
Sq
Square (package shape)
TBA
Tetra Brik Aseptic
TCA
Tetra Classic Aseptic
TFA
Tetra Fino Aseptic
TPA
Tetra Prisma Aseptic
TPCA
Tetra Pak Carton Ambient
TPCC
Tetra Pak Carton Chilled
TPIH
Tetra Pak Induction Heating
TS
Transversal Sealing
TTC
Technical Training Centre
TWA
Tetra Wedge Aseptic
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SM
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(Cont'd)
i Introduction
Reference documents
Reference documents Refer to the following other documents: OM pecularities of the filling machine TTC Package Integrity Compact Disk CD-00002-01
•
TTC TS evaluation brochure 1991
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• •
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i Introduction
Manual Information
Manual Information Page Layout Every main page in this manual contains a header and a footer. The page header contains the section name (1) and the chapter name (2). The page footer contains the manual’s document number (3), and the page number (4). See also the section Page Numbering.
1
2
1.2 Transversal Seal - Evaluation by tearing (P 1201)
1 Transversal Seal (TS) Prepare samples for TS accurate check
1 Cut off the top and bottom of the packages at a distance of about 25-30 mm from the top and bottom creases.
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4
3 1 2 3 4
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Section name Chapter name Document number Page number
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Issue 1
Cut off 1 mm maximum from the edges.
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2
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Rinse the samples and dry them with compressed air.
i Introduction
Manual Information
Page Numbering A page number has three parts: • • •
chapter number (1) consecutive page number (2) within the chapter total number of pages (3) in the chapter.
4 - 11 (18) 1
2
1 Chapter number 2 Consecutive page number 3 Total number of pages
3
Typographical Conventions
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Symbols The following symbols are used in illustrations: • A pointer arrow (1) indicates the position of an object • A zoom arrow (2) indicates that an object view is enlarged. The arrow points towards the enlarged view of the object • A rotation movement arrow (3) indicates rotational movement of an object. The arrow points in the direction of rotation • A straight movement arrow (4) indicates movement of an object. The arrow points in the direction of movement
1
4
2
5
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Pointer arrow Zoom arrow Rotation movement arrow Straight movement arrow
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i Introduction
Manual Information
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ii Safety Precautions
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ii Safety Precautions
Safety Messages Description
Safety Messages Description A safety message is always accompanied by a safety alert symbol and a signal word.
This is the safety alert symbol. It is used to alert about potential personal injury hazards. To avoid hazards, obey all safety messages that follow this symbol. The following safety alert symbols and signal words are used in this manual to inform the user of hazards.
ii - 2 (2)
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CAUTION Caution indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. CAUTION Caution without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage.
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WARNING Warning indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
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iii Getting to know the Package
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iii Getting to know the Package
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This chapter contains basic information on how a TPCA package is sealed and formed; which are the major differences on packaging materials, and where the defects are located.
iii Getting to know the Package
Table of Contents
Aseptic Packaging. . . . . . . . . . . . . . . . . . . . . . . . iii - 5 Packaging Material . . . . . . . . . . . . . . . . . . . . . . . iii - 6 Packaging Material Layers . . . . . . . . . . . . . . . . . . iii - 7 Guidelines for the choice of Packaging Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii - 9 Packaging Material Reel . . . . . . . . . . . . . . . . . . . iii - 10 Pre-Laminated Hole . . . . . . . . . . . . . . . . . . . . . . . iii - 11
Package Terminology . . . . . . . . . . . . . . . . . . . . iii - 12
LS Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii - 14 TechPub_2614345_0103 - BoC_2712261_0101_gtk.fm
PT Strips (Tab, Patch, Outer Patch) . . . . . . . . . . iii - 15
Identification of package defects . . . . . . . . . . . iii - 16
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Strips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii - 14
iii - 4 (16)
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iii Getting to know the Package
iii Getting to know the Package
Aseptic Packaging
Aseptic Packaging Aseptic packaging prevents microbes and bacteria from getting in once the package is closed. Obviously, this is a great advantage for foods and drinks. For packaged foods and drinks to be completely free from infection, the product itself must also be sterile. In other words the following conditions must be achieved: • Sterile product: The product itself must be sterile. • Sterile product supply: The equipment delivering the product to the filling machine must be sterile. • Sterile packaging material: The packaging material must be sterile when it comes in contact with the product. • Sterile filling environment: The part of the filling machine where package filling actually takes place must be sterile. •
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This is taken care of by the filling machine.
Sterile packaging material
Sterile filling environment
Sterile product
Sterile product supply Aseptic package
This is taken care of by the processing equipment in the factory.
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iii Getting to know the Package
Packaging Material
Packaging Material The packaging material protects the product inside the package from the environment outside. It also needs to be firm enough to give the package a good shape.This is essential for transport and handling. The packaging material is also printed with information about the contents of the package. The packaging material used in the filling machines is a very special laminate material. “Laminate” means that the material is made up of several different layers. Though different products may require slightly different packaging materials, all TPCA Packaging Materials are “laminate”.
TBA package is shown
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When the packaging material is shaped into packages it is folded along preformed creases. The heavy gray lines in the drawing to the right show the crease pattern for one package.
iii Getting to know the Package
Packaging Material
Packaging Material Layers The packaging material used is multilayer. The different combination of layers determines the type of material. All of the packaging materials contain a paperboard layer (2), an Al-foil layer (4) and a variable number of plastic based (usually LDPE or me-PE) layers. The paperboard gives stability to the package and allows printing of the design and data. The Al-foil acts as a barrier against aroma, oxygen and light. It also protects the flavour of the product and it is used to seal, by induction heating, layers (3), (1). The polyethylene (LDPE, m PE) allows the adhesion of the different materials, seals in the liquid and protects the package from external moisture.
1. Outside plastic layer/Decor layer Protects the package against external humidity. Also allows sealing of the package (Flaps and Overlap).
4. Al-foil Protects the product against oxygen and light.
2. Paperboard and printing Strengthens the package and offers a good printing surface.
3. Lamination A plastic layer which allows the paperboard to stick to the al-foil.
5. Internal coating A coating that offers adhesion between the al-foil and the inside plastic layer.
6. Inside plastic layer Prevents the liquid contents from soaking into the material. Also allows sealing of the package (SA, LS, TS).
(Cont'd)
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The package microbiological barrier is composed by layers (6), (5), (4), (3).
iii Getting to know the Package
Packaging Material
(Cont'd) The picture below describes what type of effects the different layers in the Packaging material protect against.
Light, Aroma, Oxygen Inner Sealing
External moisture
4
2 1 3
Package Stability
7 Microbiological barrier
1 2 3 4 5 6 7
iii - 8 (16)
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Outer coating Paperboard Lamination Al-foil Internal Coating 1 Internal Coating 2 Product
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5
iii Getting to know the Package
Packaging Material
Guidelines for the choice of Packaging Material This is an extract from the Carton Ambient Product Portfolio booklet (FDM 11th edition). Please refer to it for any official info about Filling and Distribution Machines, Packaging Material and Strips. --/m
Plain milk, sweetened milk
--/j
--/aqk
--/ok --/olk
x
UHT Cream and nondairy milk Coconut drinks, soy bean drinks, rice drinks
LS strips PPP (or MPM (2))
x
Flavoured milk Recombined milk
PPP (or MPM (2))
x
PPP (or MPM (2))
x
PPP (or MPM (2))
x
Formulated tomato
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--/lk(1)
PPP (or MPM (2))
Fruit and vegetable juices and drinks
x
PPP (or MPM (2))
Teas and coffees
x
PPP (or MPM (2))
Wine
x(4)
Wine
Alcohol drinks <20 %
x(4)
Wine
Dressing
x x
Soups and Sauces
x
Alcohol drinks >20 %
x
Oil Vinegar products max.1.0% acetic acid
Special dietetic products
x x
Flavoured water
PPP (or MPM (2))/ LSE (or MSE) PPP (or MPM (2))
x(3)
Water
PPP (or MPM (2))
PPP (or MPM (2))
x
Products for hot-vending machines Nutritional products
Wine
x
PPP (or MPM (2))/ LSE (or MSE)
x(3)
PPP (or MPM (2))/ LSE (or MSE)
x
PPP (or MPM (2)) PPP (or MPM (2)) PPP (or MPM (2))
(1)
The use of --/lk materials is equivalent to --/jk, --/tk and --/wk materials. MPM and MSE to improve the strip sealability. MPM strip does not impart higher barrier properties than PPP, such as MSE has the same barrier properties as LSE. (3) According to the specific formulation per each different product. (4) The use of --/j material for packing wine and alcoholic drinks <20% is approved. The --/w material production will be discontinued. (2)
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Product type
iii Getting to know the Package
Packaging Material
Packaging Material Reel A label indicating packaging material type (i.d. TBA/m, TBA/j, TBA/jl, TBA/lk) and Production Order is attached to each reel. Always keep the label and quote the data when performing package integrity tests.
2
Tetra Pak TP ORDER
TP PRODUCT
P202-0123456 D00-0000-01 CUST No
ID No
Tetra Pak Carton Ambient S.p.A Via Delphini 1 MODENA
123456789
Photocell TBA/J FCD
123-4567 TYPE
TBA/J
VOLUME
REEL No
QUANTITY
PROD DATE
01-0001
7500
25-MAY-2008
9
12345678910 11121314151617181920
10
11 1 2 3 4 5 6 7 8 9 10 11
iii - 10 (16)
Customer address Tetra Pak product code Tetra Pak Production Order number Customer code Identification number Type of Packaging Material Volume of package Quantity of packages on the reel Reel number Date of Production Bar code containing parts of the above information
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1000 ml
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3 4 5 6 7 8
1
iii Getting to know the Package
Packaging Material
Pre-Laminated Hole The Pre-Laminated Hole is presently used for packages with Post-applied Caps. The hole is punched and laminated during converting. The cap is applied after product filling and package leaving the Filling Machine. Note! The PLH does not require dedicated package evaluation procedures for Package Integrity tests (as for PullTab and FlexiCap). Pre-Laminated Hole
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Post-applied cap
1
2
outside of package
inside of package
6 5
4
3
1 2 3 4 5 6
Outside plastic layer (decor layer) Paperboard Laminate layer Alu-foil Inner layer 1 Inner layer 2
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iii Getting to know the Package
Package Terminology
Package Terminology •
• •
Longitudinal creases, top creases and bottom creases: These are the pre-formed folds in the packaging material. They give the package its final squared form. Top fin and bottom fin.: These are the top and bottom areas of the package where it is sealed and cut. Transversal seal (TS): Seals the package at the top and bottom. Top longitudinal creases Top fin Transversal seal (TS)
Bottom fin
Longitudinal sealing
Transversal seal (TS)
(Cont'd)
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Top longitudinal creases
iii Getting to know the Package
Package Terminology
(Cont'd) • •
•
•
Longitudinal seal (LS): Seals the package along the long side. LS strip: A strip of laminated plastic applied on the inside of the longitudinal seal. Prevents the product from soaking into the edge of the packaging material. LS overlap: The area over which the two edges of packaging material overlap down the long side of the package. Ensures that the longitudinal seal is rigid and does not leak. Top and bottom flaps: The corners of the package that are folded and sealed to the package body.
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Top flap
Top flap
inside of package Longitudinal seal (LS)
LS strip
Bottom flap LS overlap
outside of package
Bottom flap Bottom crease
LS strip
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Top creases
iii Getting to know the Package
Strips
Strips LS Strip The LS strip has the following tasks: • it prevents liquid from being absorbed by the packaging material edge; • it prevents micro-organisms which could be present on the packaging material edge from contaminating the product; • it creates a gas barrier in the longitudinal seal which prevents both aromatic substances from escaping through the seal and air (oxygen) from penetrating and affecting the product; • it reinforces the longitudinal seal.
LHL
PPP/PPPw Primer PET
HDPE
Milk LDPE
Juice / Wine
LDPE
MPM
LSE
mLLDPE LDPE
LDPE
Primer
Primer
PET
EVOH
TBA/jl (TBA Wide)
Primer
Primer LDPE
Primer
Special products
LDPE mLLDPE
(Cont'd)
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LDPE
LDPE
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LS strips are formed by different layers and have different utilisation depending of the product and package type. Here below some examples:
iii Getting to know the Package
Strips
(Cont'd)
PPP-STRIPS 7,5/0,075 449732:16:3 TechPub_2614345_0103 - BoC_2712261_0101_gtk.fm
lot number
PT Strips (Tab, Patch, Outer Patch) A label identifying strip type and lot number is attached to every strip box. Take note of these data and quote them when performing package integrity tests.
UNIFIED TAB STRIP 1234-123
PEP-STRIP 29/0,050 ART. NO
LOT NO.
1234-123 123456 12341212
REELS
10
USE BEFORE DATE
12345678910 11121314151617181920
NET WEIGHT KG
123456 123456
PALLET - BOX NO.
Quantity Lot. No. Prod. date
1234 m 123345678 1234-12-12
Use before: 1234-12-12
12345678910 11121314151617181920
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A label identifying strip type (i.d. PPP, MPM) and lot number is attached to every strip reel. Take note of these data and quote them when performing package integrity tests.
iii Getting to know the Package
Identification of package defects
Identification of package defects Defect location
Defect name
MTD
1
LS
- not sealed - blisters - channels
1202
2
Corners
- red ink leakage
1203 - 1204
3
TS
- channel / blocking - plastic lumps - overheating - Af-foil TS crack - fibres trapped in TS
1201 (Production) 1208 (QC, Troubleshooting) 1210
4
TS/LS cross
- channels - plastic lumps
1208 (QC) 1201 (Production)
5
PullTab / Opening
- red ink leakage
1211
6
Fin
- top fin tearing - bottom fin tear (TWA only)
1204
7
Bottom flap
- k-cracks leakage
1203 - 1204
6
3 4 2
5
1
7
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The following table summarizes the defect location on the package and which MTD has to be followed to identify them:
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1 Transversal Seal (TS)
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1 Transversal Seal (TS)
Methods:
Methods: MTD 1201 - Transversal Seal Tearing Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents • Previous version, MTD 1201, issued by Sara Davolio, 1996/02/27. TTC TS evaluation brochure 1991.
Personnel This method must be performed by Specialized personnel. Refer to section Personnel Requirements, page i-5 for details. Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD 1208 issued by Sara Davolio, 1996/11/19.
MTD 1210 - Transversal Seal Al-foil cracks Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD 1210, issued by Sara Davolio, date 1996/02/29.
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MTD 1208 - Transversal Seal Dissolving and Red Ink
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•
Table of Contents
1 Transversal Seal (TS)
1.1 Transversal Seal - General information. . . . . . . 1 - 5 1.2 Transversal Seal - Tearing (MTD 1201) . . . . . . . 1 - 7 1.2.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 7
1.2.2
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 8
1.2.3
Preparation of the Samples. . . . . . . . . . . . . . . . . . 1 - 9
1.2.4
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 11
1.2.5
Evaluation of the Samples . . . . . . . . . . . . . . . . . 1 - 13
1.3.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 16
1.3.2
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 17
1.3.3
Preparation of the Samples. . . . . . . . . . . . . . . . . 1 - 19
1.3.4
1.3.3-1
Cut packages . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 19
1.3.3-2
Dissolving of packages . . . . . . . . . . . . . . . . . . . 1 - 22
1.3.3-3
Drying the samples . . . . . . . . . . . . . . . . . . . . . . 1 - 29
1.3.3-4
Red Ink Tightness . . . . . . . . . . . . . . . . . . . . . . . . 1 - 30
Evaluation of the Samples . . . . . . . . . . . . . . . . . 1 - 31
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 37 1.4.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 37
1.4.2
Preparation of the Samples. . . . . . . . . . . . . . . . . 1 - 38
1.4.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 39
1.4.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . 1 - 40
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1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 16
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1 Transversal Seal (TS)
Table of Contents
1 Transversal Seal (TS)
1.1 Transversal Seal - General information
1.1 Transversal Seal - General information The Transversal Seal is formed in the jaw system by two jaws working in pairs (e.g. Tetra Pak A3/Flex and TBA/21) or in 10 jaws linked in chain working in pairs (e.g. Tetra Pak A3/Speed and TBA/22). • •
the sealing jaw (A) contains the inductor the pressure jaw (B) contains the pressure rubber dollies and the cutting knife plus the cutting rail.
Note! In some filling machine applications the names of Sealing Jaw and Pressure Jaw can be different (Cutting Jaw is also used). 2 Jaws working in pair
10 Jaws linked as chain
3
4
3
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5
5 2
2
2
1
2
6
6 1
1
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1
7 10 8
9
7 10
9
8
C
A
B
A Sealing Jaw B Pressure Jaw C Volume Flap
(Cont'd)
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1 Transversal Seal (TS)
1.1 Transversal Seal - General information
(Cont'd) The inductor on the sealing jaw induces eddy currents into the Al-foil of the packaging material, producing a heat that melts the plastic layers in the area where the sealing is needed. The rubber dollies on the pressure jaw exert pressure, allowing the plastic layers to be sealed together. The pressure is produced hydraulically or mechanically depending on the machine type. The knife cuts the packaging material tube separating the packages. Each pair of jaws makes two seals, i.e. the bottom seal of one package and the top seal of the next one. Most applications use Ridge inductor, but in most of TCA, TFA and some TWA applications inductors with lower ridge might be used.
1
4 5
2 4 10
7
3
8
9
9
10
10 6 11
11
10
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1 1 2 3 4 5 6
Dolly Cutting rail Knife Upper package Heat pattern Inductor coil
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7 8 9 10 11
Inductor body Cutting groove PM cutting line Ridge Lower package
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1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1.2 Transversal Seal - Tearing (MTD 1201) 1.2.1 Introduction The method consists in pulling the transversal sealing apart using the stretch pliers and examining how the seal separates. By visually checking the seal, it is possible to notice the presence of plastic ridges or lumps along it. These ridges could punch the packaging material layers, compromising the integrity of the package. The seal must be mechanically stronger than the packaging material. If the sealing is good, the packaging material layers (plastic film, Al-foil or paperboard) break while the seal does not separate.
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1
Upper Package
6
7
6
8
3
10 Upper Package
4 TOP TS
5 BOTTOM TS
9 Lower Package
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2
Lower Package
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1 2 3 4 5 6 7 8 9 10
Filling product Al-foil Paperboard Cutting line Plastic film, double layers Blocked area Sealed area Ridge Outer coating Stretch pliers
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1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1.2.2 Definitions Blocked seal Blocked seals are often called cold sealings. Since the reason for a blocked sealing might be either low setting or low pressure the term cold sealing refers mainly to energy. Note! The only way to detect a blocked seal it is the manual Tear Down during Production. Conductivity test and Red ink test would not detect a blocked seal.
1
1 2 3 4 5 6 7 8 9
Filling product Al-foil Paperboard Cutting line Plastic film, double layers Blocked area Sealed area Ridge impression Outer coating
6
2
7
8
6
3 5
4
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The TS with a good heat pattern will progressively tend to appear as blocked, when torn by means of the stretch pliers or by hand. This effect, called decay, typical of wet sealings, depends on the filling product (water included), sealing settings, packaging material and storage time. For this reason during troubleshooting and after production (1 week is the reference interval considered), dissolving and heat pattern analysis is the only reliable method to access the TS quality.
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Decay
1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1.2.3 Preparation of the Samples Note! The test must be performed during Production. If special activities are planned on the samples (i.e. sealing window), the test can be carried out within 1 week from production.
Prepare samples for TS rough check Unfold the top and bottom flaps of the package.
If there is product leakage, the TS has a gross defect (most likely a dolly is missing).
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If any product leakage is found stop the machine and call a technician. Note! If there is any leak from between the PLH and the package, it is not due to the TS sealing. Call a service technician.
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Check if the package has product leakages from the TS by gently squeezing the package with the fingers.
1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
Prepare samples for TS accurate check
1 Cut off the top and bottom of the packages at a distance of about 25-30 mm from the top and bottom fin creases. Rinse the samples and dry them with compressed air.
Cut off 1 mm maximum from the edges.
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Note! Use compressed air with care since it might damage the sample.
1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1.2.4 Procedure TS rough TS check Check the integrity of the TS by gently squeezing the package with the fingers. If there is product leakage, the TS has a gross defect (most likely a dolly is missing).
TS accurate check
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Run you finger over the TS and check if there are plastic lumps or ridges. Plastic lumps and ridges show that the sealing is not correct. See section 1.2.5 Evaluation of the Samples for further details.
2 Place the sample in the stretch pliers and gently stretch the TS.
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1
1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1
2
2
3
3
2
2
1
1
3 Stretch by pressing the plier handles along the whole length of the sample Stretch a little bit at a time, from both ends (1) towards the LS/TS cross (3). Stretch the LS/TS cross last. CAUTION Risk of sample damage. Take a lot of care in the point where the TS and LS cross and on the edges, since the magnetic field and heat pattern is weaker in these areas. The cross might be the last part stretched to enable a better evaluation.
WRONG
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1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
1.2.5 Evaluation of the Samples The seal can be either good or defective. A seal is good when it is mechanically more resistant than the packaging material. If a seal is defective, it could easily cause unsterility. The first sign of a good seal is stretched plastic film. Breakage in the Al-foil and paperboard layers also shows that the seal is stronger than the packaging material. The rules apply also in the TS/LS cross where the strip is part of the seal. Here you have some representative examples of good and defective seals.
1
1
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Plastic lumps are a potential danger in the aseptic package. The hard residue might punch the PM layers during distribution of the package compromising the package integrity.
Defective seal Plastic lumps are the signal of a too high or uneven sealing temperature, too high pressure or wrong jaw system alignment.
2 The seal does not come apart; the plastic film stretches and breaks, leaving the paperboard uncovered.
Good seal
Typical behaviour of TBA/lk and TBA/jl
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Before pulling the seal apart, it is easier to notice the presence of plastic ridges or lumps along it.
1.2 Transversal Seal - Tearing (MTD 1201)
1 Transversal Seal (TS)
3 The case described above applies also to the cross, where TS and LS meet. The LS must be considered and additional plastic multilayer. The picture shows the LS which stretches and delaminates.
Good seal
Good seal
Typical behaviour of TBA/j (that has high adesion to Al-foil)
5 The plastic film layers separate from the Al-foil, leaving it uncovered and shiny.
Good seal
Typical behaviour of TBA/jm (that has low adesion to Al-foil)
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The seal does not come apart; the plastic film breaks leaving the paperboard fibres and the Al-foil uncovered.
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4
1 Transversal Seal (TS)
1.2 Transversal Seal - Tearing (MTD 1201)
6 The seal separates; no rupture occurs in the packaging material layers. The seal appears mattish or greyish. This is a so called blocked seal.
Blocked seals are often due to too low sealing temperature or too low pressure during sealing. Energy settings must be adjusted, inductors and dollies checked and jaw pressure verified.
7 TechPub_2614345_0103 - 01_2712261_01_en.fm
The seal is overheated; the two PE layers are burnt and the Al-foil shows microcracks and cuts.
Defective seal Overheated seals are often due to too high sealing temperature or by excessive pressure. Sealing settings, cooling water temperature or jaw pressure must be adjusted.
8 The Al-foil is cracked in the ridge area.
Defective seal Further investigate the packages to detect Al-foil cracks along the TS, see 1.4 Transversal Seal - Al-Foil Cracks (MTD 1210).
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Defective seal
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208) 1.3.1 Introduction This section describes the method to evaluate the Transversal Seal (TS) by dissolving the Al-foil (2) with chemical agents and separating the inner plastic layers (5) from the other package layers, obtaining a inner plastic bag. The inner plastic bag (see picture below) is then analysed to check the heat distribution along the TS (heat pattern). The TS tightness is tested using the leakage detection fluid (red ink).
1
TOP TS
7
8
6
3
TOP TS
BOTTOM TS
4
5 Lower Package
Upper Package
9
Lower Package
BOTTOM TS 1 2 3 4 5
Filling product Al-foil Paperboard Cutting line Plastic film, double layers
6 7 8 9
Blocked area Sealed area Ridge impression Outer coating
(Cont'd)
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Upper Package
6
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2
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3.2 Definitions Heat pattern The heat pattern is the mark left by the inductor on the packaging material during sealing. The pictures below shows the Heat pattern areas.
Heat pattern
= heat pattern
Ridge impression
Lower Blocked area
LS
LS / TS cross
Air channel
Upper Blocked area
Bending Off
(Cont'd)
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Ridge impression
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
(Cont'd) The heat pattern can be analysed with the use of a zonoscope and a magnifier. The heat pattern must be symmetrical with respect to the LS and the cutting line and fulfil the geometrical measurements shown below. The causes of uneven distribution are mostly unparallel pressure distribution, banana shaped inductors or dollies status.
Dimension
Acceptable (mm)
NOT Acceptable (mm)
A
0
>0
B
≥ 0.2 ≥1 ≥1
< 0.2
D
D
<1 <1
C
B
A
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Note! These dimensions are in general not influenced by the filling machine (e.g. the heat pattern of a TBA/21 is similar to the heat pattern of a TBA/22 given the package size). D, usually, is wider than C.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3.3 Preparation of the Samples 1.3.3-1
Cut packages
1 CAUTION Risk of sample damage! Always handle the samples with care. Mechanical stress due to improper handling can compromise the results of the test.
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The along the TS should be about 50 mm wide with the LS at its central axis. Cut out the front panel of the package at approximately 25 mm from the top and bottom TS.
2 Mark each sample in order to distinguish the Top and Bottom seal after dissolution. For example, write T (for Top) and B (for Bottom) on the inside of the package with a permanent marker. Mark the samples with progressive numbers. Note! If packages was containing high fat products it might be difficult to use the permanent marker.
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Unfold all the flaps and flatten the package. Cut the package in a I shape, as shown in the picture.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
3 If possible, cut the top of the package using the pinking scissors for an easy identification of the top. The scheme below shows the PM layers before starting the procedure:
3 4 5 6
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1 2
Outer coating Paperboard Lamination Al-foil Inner coating 1 Inner coating 2
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1 2 3 4 5 6
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
4 Carefully peel off the external packaging material layers (starting from the LS overlapping), as shown in the top picture. The outer polyethylene layer and part of the paperboard layer will come off. The sample in the bottom picture will be obtained. Note! TFA packages do not need this step since the paperboard is too thin to peel apart.
2 3 4 5 6
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The PM layers left, at this stage, on the sample are the following: Paperboard Lamination Al-foil Inner coating 1 Inner coating 2
2 3 4 5 6
TCA packages Prepare the packages as shown in the picture.
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1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3.3-2
Dissolving of packages Packages can be dissolved either using an acid or an alkaline solution. See chapter 1.6 Preparation of Chemicals for details on the composition and preparation of the solutions. There are three methods that can be followed according to the urgency of results:
•
The alkaline agent (slow method) acts more slowly; the samples must stay immersed in the solution for at least 6 hours. This method is advisable when there are many samples to evaluate (e.g. during troubleshooting). Dissolving of packages methods
Solutions used
Acid agent method 1 (very fast)
Acid agent method 2 (fast) *
- HCl 1:1 solution - HCl 1:3 solution - Neutralizing solution
- HCl 30% solution - Neutralizing solution
Alkaline agent (slow)
- Alkaline solution - Neutralizing solution
Advantages
very fast (sample ready in 15 min)
fast (sample ready in less than one hour)
safer (no acid solutions involved)
Disadvantages
risk of spoiling of the sample with too long immersion in solution
not very fast as Acid agent method 1
slow (sample ready in 6 hours)
go to page 1-23
go to page 1-26
go to page 1-28
* used in Tetra Recart applications
(Cont'd)
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The acid agent (very fast method) acts fast, therefore it is advisable when the results of the test are urgent (e.g. during Production). A fume extractor and a water bath are needed for preparation and usage. The acid agent (fast method) acts slower that the above solution, but is faster than the alkaline solution. With this method is possible to obtain the samples in less than one hour. Fume extractor is highly recommended.
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•
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
(Cont'd) Acid agent method 1 (very fast) WARNING Risk of personal injury! Observe safety regulations when working with acids. Preparation and handling of HCl solutions must be carried out in a well-ventilated environment, as fumes may be given off. Always wear protective goggles and gloves. Use heat resistant beakers for preparation and storage. Exhausted chemicals must be disposed of in accordance with current regulations.
1
Immerse the samples in HCl 1:1 solution one at a time for approximately 4 minutes at temperature between 55° C and 60° C. Use a water bath. Note! Temperature settings might need adjustments given the equipment used.
2 Remove the samples from HCl 1:1 solution and immerse them in the Neutralizing Solution to neutralize the acid. Neutralizing Solution solution should bubble as soon as the samples are immersed; if not, prepare a new solution.
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Note! Always use the tongs to immerse and remove the sample from the solutions, avoiding the contact with the hands.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
3 The external lamination layer should easily separate from the Al-foil by mechanical hand action. The inner plastic layers and the Al-foil are left. The Al-foil will be dissolved in the next step. The PM layers left, at this stage, on the sample are the following:
6
4 Note! This step is the most sensitive. The temperature of HCl 1:3 solution increases when samples are immersed into it, therefore there is a high risk of burning the packages. CAUTION Risk of sample damage! Bath 2 must be at room temperature. Immerse the samples into HCl 1:3 solution, no more than two at a time, until Al-foil is dissolved. Keep the samples in motion to reduce the temperature.
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4 Al-foil 5 Inner coating 1 6 Inner coating 2
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
5 The Al-foil comes off. The inner plastic bag, eventually isolated, must be first neutralized in the Neutralizing solution, then rinsed carefully under tap water. The PM layers left at the end of the dissolving are the following:
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5 6
6 Dry the samples, see 1.3.3-3 Drying the samples.
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5 Inner coating 1 6 Inner coating 2
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
Acid agent method 2 (fast) WARNING Risk of personal injury! Observe safety regulations when working with acids. Preparation and handling of HCl solutions must be carried out in a well-ventilated environment, as fumes may be given off. Always wear protective goggles and gloves. Use heat resistant beakers for preparation and storage. Exhausted chemicals must be disposed of in accordance with current regulations.
1
2 Remove the samples fromthe HCl 30% solution and immerse them in Neutralizing solution to balance acidity.
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Immerse the samples in the HCl 30% solution one at a time for approximately 1 hour.
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Note! Always use the tongs to immerse and remove the sample from the solutions, avoiding the contact with the hands.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
3 Rinse the samples under tap water. The external lamination layer and the Al-foil should easily separate from the inner plastic layer. The PM layers left at the end of the dissolving are the following:
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5 Inner coating 1 6 Inner coating 2
5 6
4 Dry the samples, see 1.3.3-3 Drying the samples.
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1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
Alkaline agent (slow)
1 Carefully immerse all the samples in the dissolving solution. Leave the beaker uncovered to allow hydrogen fumes to be ventilated. If fresh, the solution should immediately start to bubble. If not, prepare a new solution.
Make sure the Al-foil has dissolved completely; if not leave the samples in the solution a little longer or prepare a fresh one. 15% of citric acid solution might be used to neutralize the samples. Rinse the samples under tap water and carefully separate the inner plastic bag. The PM layers left at the end of the dissolving are the following: 5 Inner coating 1 6 Inner coating 2
5 6
3 Dry the samples, see 1.3.3-3 Drying the samples.
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Leave the samples in the dissolving solution for at least 6 hours, or until no Al-foil is visible on the upper samples.
1 Transversal Seal (TS) 1.3.3-3
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
Drying the samples
1 CORRECT
1
Carefully dry the inside of the samples with paper tissue (1) and dry thoroughly on filter paper, in a well ventilated area. The presence of water may interfere with the results of the test.
WRONG
2 Spoiled samples must be discarded. The picture shows a sample that has been heated too much during the chemical exposure, becoming unreliable.
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CAUTION Risk of sample damage! Do not reverse the bags while drying them, or they could be spoilt.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3.3-4
Red Ink Tightness
1 CAUTION Risk of sample damage! Handle the samples with care. Mechanical stress due to improper handling can compromise the results of the test. Take one sample at a time, make sure that it is completely dry.
Let the red ink spread along the TS. Hold the sample with both hands and visually check it. If the TS is not tight and there are channels in it, the red ink will pass to the outside of the bag. If the result is doubtful, let the samples dry and repeat the red ink test, at room temperature. Filter paper can be used to see spots of red ink passing through the sealing.
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Put some red ink with a plastic pipette inside the plastic bag along the TS.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1.3.4 Evaluation of the Samples Irregularities of the TS which are easy to notice at this point are the following: • plastic lumps; • Al-foil TS cracks; • • • •
product residue; overheated seal; channels (unsealed spots) cuts in the ridge area.
• •
bending off sealing simmetry
1
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The sealing is even, the heat pattern is regular, no cracks are visible. The sample shows bubbles that might appear after the dissolving due to the chemical exposure. Those bubbles are not evidence of anomalies in the sample.
Good seal 2 The sealing is smooth, the heat pattern is regular, no cracks are visible.
Good seal
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Here you have some representative examples of TS.
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
3 The sealing is smooth, the heat pattern is regular, no cracks are visible.
Good seal
Good seal
5 The sealing shows cuts in the ridge area that might be due to dissolving procedure or high pressure.
Good seal
6 The sealing shows tiny bubbles toward the product side that do not reach the ridge (very typical for TBA/22 040).
Good seal
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The heat pattern is not regular towards the cutting side suggesting jaw pressure or knife problems, however, this sealing is still acceptable for package integrity but defect might arise.
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1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
7 Solid LDPE can be found at the fin, at the cutting side. Pressure and cutting might need verification.
Good seal
Trapped product might be spotted in the sealing. Further analysis could be needed. If the red ink does not pass through, the sealing is good.
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Good seal
9 Al-foil TS cracks The TS shows lack of PE along the ridge. This rupture corresponds to a crack occurred in the Al-foil during the sealing pulse, which caused and interrupted the resulting heat pattern. Refer to MTD 1210 for details.
Defective seal
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1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
10 Plastic lumps The TS shows plastic lumps.
Defective seal
11
Defective seal
12 Overheating The seal shows bubbles and melted spots. This indicates that the sealing temperature setting was too high or unparallel jaw pressure.
Defective seal
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Product resides (e.g. fruit juice fibres) are trapped into the TS and pass the ridge. Fibres can create channels inside it or perforate the TS up to the paperboard.
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Product residue
1 Transversal Seal (TS)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
13 Cutting knife and pressure problems The seal shows channels from the cutting area towards the product side.
Defective seal
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The seal shows channels from the cutting area towards the product side.
Defective seal
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14
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
1 Transversal Seal (TS)
Here you have some examples of good and defective heat patterns.
A
Good seal Defective seal
Defective seal
C
Good seal
Defective seal
D
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Good seal
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B
1 Transversal Seal (TS)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210) Note! This procedure is very uselful as troubleshooting procedure.
1.4.1 Introduction The purpose of this method is to detect cracks which can occur in the Al-foil along the ridge, especially in the fin corners. This method has been developed for filled packages produced in filling machines with ridge inductor. Package integrity can be compromised if the crack arises at the ends of the seal, before or during the pulse. The current circulation in the Al-foil is interrupted by the crack and the sealing is not performed correctly. As a result, the heat pattern (distance A) does not comply with the minimum required values. •
packaging material;
• • •
status of the sealing components; TS configuration; tolerances of the machine settings (i.e. design correction and folding flaps); TS power setting; jaw pressure.
• •
Good
A
A
Defective
Defective
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At the present level of knowledge, the occurrence of cracks depends on:
1 Transversal Seal (TS)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
1.4.2 Preparation of the Samples 1 Unfold all the flaps of the package samples.
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Make a cut, either with scissors or a cutter, 5 cm long, on one side of the package to empty it from its content.
3 Starting from the LS overlap, tear away the outer layers of packaging material over the top and bottom TS. Mark top and bottom of the package to identify them.
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1 Transversal Seal (TS)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
1.4.3 Procedure 1
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2 If the light source at your disposal is not powerful enough, dip the packages in warm water and carefully remove the paperboard layers covering the Al-foil in the TS area with an abrasive sponge.
3 Put the samples against the light source and look for cracks in the Al-foil along the ridge.
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If a very bright lamp is available, put the edge of the sample against the light source. The area in which the light passes through the packaging material corresponds to a crack in the Al-foil.
1 Transversal Seal (TS)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
1.4.4 Evaluation of the Samples 1 A crack is defined as any spot through which the light, from a source placed below the sample, can be seen, as shown in the picture.
• •
machine settings (design correction and folding flaps); TS power setting;
• •
status of the sealing components TS configuration
2 Defects are visible also with the aid of a magnifying lens or microscope. This seal shows a crack due to excessive pressure of the dollies or knife return problems, which does not cause a magnetic field interruption. The heat pattern is regular. This is NOT a TS Al-foil crack (cracks out of the ridge area).
Good seal 3 This crack compromises the distribution of heat along the TS; the heat pattern will consequently be irregular. This is a TS Al-foil crack in the ridge area.
Defective seal
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Defective seal
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Cracks are due to problems connected with: • packaging material;
1 Transversal Seal (TS)
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
4
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For further investigation dissolve the packages, see 1.3 Transversal Seal Dissolving and Red Ink (MTD 1208) and analyse the heat pattern, to confirm its irregularity.
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1 Transversal Seal (TS)
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1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
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2 Longitudinal Seal (LS/SA)
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2 Longitudinal Seal (LS/SA)
Methods:
Methods: MTD 1202 - Longitudinal Seal Tearing Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD 1202, issued by Sara Davolio, date 1996/11/18.
Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD 1202, issued by Sara Davolio, date 1996/11/18.
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Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details.
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MTD 1202 - Longitudinal Seal by Red Ink
Table of Contents
2 Longitudinal Seal (LS/SA)
2.1 Longitudinal Seal - General information . . . . . . 2 - 5 2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 7 2.2.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 7
2.2.2
Preparation of the Samples. . . . . . . . . . . . . . . . . . 2 - 8
2.2.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 9 Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 9
2.2.3-2
Mechanical test . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 12
Evaluation of the Samples . . . . . . . . . . . . . . . . . 2 - 14 2.2.4-1
Rolling ball point pen test (after mechanical tear down) . . . . . . . . . . . . . . . 2 - 17
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2.3 Longitudinal Seal - Red Ink Injection. . . . . . . . 2 - 18 2.3.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 18
2.3.2
Preparation of the Sample. . . . . . . . . . . . . . . . . . 2 - 19
2.3.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 21
2.3.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . 2 - 22
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2.2.4
2.2.3-1
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2 Longitudinal Seal (LS/SA)
Methods:
2 Longitudinal Seal (LS/SA)
2.1 Longitudinal Seal - General information
2.1 Longitudinal Seal - General information This seal creates the tight tube of packaging material just before product filling. A strip of PE (LS strip) is attached to one edge of the packaging material before sterilization by the Strip Applicator (SA) (Figure 1) by hot air or induction heating depending on the machine type.
Figure 1
Figure 2
The Strip Applicator side (SA side) (4) of the seal is where the strip was attached to the packaging material by the Strip Applicator; the packaging material edges overlap in this area. The LS side (1) is where the strip was attached to the packaging material during tight tube forming; the packaging material is single. An air gap (3) is present in the middle of the seal.
outside package
1
3
2
4
inside package
TBA package is shown
(Cont'd)
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During tight tube forming, the edge of packaging material without the strip is heated by induction or hot air depending on the machine type; the two edges are then overlapped and pressed together to create the sealing (Figure 2).
2 Longitudinal Seal (LS/SA)
2.1 Longitudinal Seal - General information
(Cont'd)
SA
LS
TBA/3
hot air
hot air
TFA/3
hot air
hot air
TBA/9 - TWA
hot air
hot air
TBA/8
hot air
hot air
TBA/19
induction heating
hot air
TBA/21
induction heating
induction heating
TBA/22
induction heating
induction heating
hot air
hot air
Tetra Pak A3/Flex
induction heating
induction heating
Tetra Pak A3/Speed
induction heating
induction heating
Tetra Pak A1
Note! Induction heating and hot air give different results in terms of visual appearance, therefore it is important to bear in mind which kind of sealing system is used in the packages under investigation. IH Sealing produces wrinkles on the Alu-foil. Higher sealing settings would not eliminate, but increase them. Hot air, on the contrary, does not usually creates wrinkles in the Alu-foil unless excessively high settings are used.
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Filling Machine
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The following table shows the type of sealing (hot air or induction heating) used in TBA machines for the sealing of SA and LS.
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202) Note! This test can be carried out during or after Production.
2.2.1 Introduction The quality of the seal is tested by tearing the LS strip manually. The seal must be mechanically stronger than the packaging material. If the sealing is good, the packaging material layers (plastic film, Al-foil or paperboard) come apart together with the strip.
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The heat distribution along the seal can be examined with the use of a zonoscope to detect possible asymmetry.
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2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2.2.2 Preparation of the Samples 1 CAUTION Risk of sample damage! Do not stress or flatten the samples since channel leaks might be induced. Unfold the flaps of the package samples.
3 Open up the sample, rinse it with water and dry it.
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Cut two opposite corners (top right, bottom left), empty the package content, and cut the sample corner to corner in a diagonal, across the front panel of the package, leaving the LS intact.
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2
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2.2.3 Procedure 2.2.3-1
Visual checks
1 Strip position
2
3
=
=
LS
SA
4
Note! The LS side (2) of the seal is where the packaging material (1) is single. The SA side (4) is where the packaging material is double.
TBA, TPA, TWA, TFA packages Check that the strip is centred in the seal.
TBA,TPA,TWA,TFA
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An air gap (3) must be present in the centre of the seal.
1
2
3
4 TCA packages In TCA packages, the strip is off-centred with respect to the seal; 2/3 of the strip cover the SA side.
TCA
1/3
2/3
LS
SA
Note! When the risk of strip folding is reported the strip (2) can be more on the SA side (naturally 2/3) than on the LS (the remaining 1/3). This is recommended for MPM type strip.
2
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1
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2 Blistering Check for any blister or bubble along the heated zone of strip. The presence of blisters in the LS side of the strip indicates too high sealing setting. The presence of blisters in the SA side of the strip indicates too high sealing setting of the Strip Applicator.
PE residue LDPE residue are trapped below the strip affecting the sealing.
Defective seal
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3
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Defective seal
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
4 Overheated LS Excessive settings or uneven pressure (LS roller not in control) result in risk of affecting the performance.
5 Heat distribution Use the zonoscope to examine the heat distribution along the LS/SA. The heat pattern must be present even on the packaging material beyond the edge of the strip. Refer to Use of the Zonoscope, page Appendix-11, when using the Zonoscope.
Defective seal
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Defective seal
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2.2.3-2
Mechanical test
1 3
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1
Cutting line is (3).
2 Pull off the outer layer of packaging material where it is double, to check the overlap.
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2
Cut the package sample along the middle of the LS (1) and LS air channel (2).
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
3 Pull the strip slowly, at an angle of 90°, 20 mm at the time.
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Note! Best results are achieved if the sample is pulled on a flat surface (table).
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2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2 Longitudinal Seal (LS/SA)
2.2.4 Evaluation of the Samples Note! Evaluate the samples soon after preparation as the sealing could be affected by the environment conditions. When pulling the LS strip (1), it must be mechanically stronger than the packaging material (2). If the sealing is good, the packaging material layers (plastic film, Al-foil or paperboard) come apart together with the strip. Delamination of the strip up to PET layer, or delamination of material up to Al-foil, are easy to see due to the shining surfaces of PET and Al-foil. Delamination of the strip layers and the internal of the PM layer is more difficult to notice.
3 3
2
1 2
1 LS Strip 2 Packaging Material 3 Cutting line
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Note! In the drawing below, the LS strip is shown in three layers for easier reading.
2 Longitudinal Seal (LS/SA)
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
1
1
Separation between the two inner coatings When the strip is pulled off and one of the inner coatings comes off with the strip (1) leaving a rupture edge (2) along the seal:
2
Good seal
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Separation between the Alfoil and the inside coatings When the strip (1) is pulled off and the two inner coatings come off leaving the Al-foil bare
Good seal TBA/j packaging material with PPP strip
3
1
Rupture in the paperboard When the strip is pulled outwards and all inner layers including the Al-foil come off with the strip (1),possibly leaving paperboard fibres (3).
3
TBA/jl packaging material with MPM strip
Good seal 4
1
Rupture in the paperboard Stretch of the Polymer and rupture to the paperboard
3
Good seal
TBA/jl packaging material with MPM strip
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2
1
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
2 Longitudinal Seal (LS/SA)
5 Separation in the LS strip
1
When the strip (1) is pulled off and one of the strip layers is left on the packaging material (i.e. strip de-lamination). This can happen also in the cross, where LS and TS meet.
Good seal 6
1
Good seal 7
1
Cold or blocked seal When the strip (1) is pulled off and it comes off leaving the inner coatings unaffected or with a greyish surface
Defective seal
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When all inner layers including the Al-foil come off with the strip (1) possibly leaving part of the inner LDPE layer (lamination layer) (4) on the paperboard.
4
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Separation of inner PE
2 Longitudinal Seal (LS/SA) 2.2.4-1
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202)
Rolling ball point pen test (after mechanical tear down)
1 Edge
Note! After the strip has been pulled away, take care not to touch the spot with fingers. Press a rolling ball point pen (see 1.5 Tools and Equipment for details) on a point of the LS edge after pulling it.
Pulled strip
Red colour pens are the best performing.
If the sealing is good, the ink moves along the sealing fracture point by capillary action. TechPub_2614345_0103 - 02_2712261_01_en.fm
Good seal
3 If the sealing is defective, the ink does not move. This means that the seal is blocked (cold).
Defective seal (blocked)
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2
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
2.3 Longitudinal Seal - Red Ink Injection 2.3.1 Introduction The quality of the LS is tested by injecting Red Ink into the air channel in the middle of the seal. The Red Ink must run along the entire channel without interruption. Any transversal channels of ink would indicate a defective seal (see section 2.3.4 Evaluation of the Samples).
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LS Ink Injection and Mechanical Tear Down are pointing at different properties. The Red Ink Injection does not substitute the Mechanical Tear Down.
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
2.3.2 Preparation of the Sample 1 CAUTION Risk of sample damage! Do not stress or flatten the samples.
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2 Cut two opposite corners (top right, bottom left), empty the package content, and cut the sample corner to corner in a diagonal, across the front panel of the package, leaving the LS intact.
3 Open up the sample, rinse it with water and dry it.
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Unfold the flaps of the package samples.
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
4
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Make an oblique cut across the LS as shown.
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
2.3.3 Procedure By red ink injection CAUTION Risk of sample damage! Do not stress or flatten the samples.
By red ink contact
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1
Evaluation can be done also by applying the red ink on the inside of the package, outside of the LS strip, by means of a pipette.
2 Leave the sample to dry or wipe the excess of red ink before looking for leakages.
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Inject 1 ml of red ink into the air channel of the LS with a 1 ml syringe. The needle should be around ø 0.4-0.5 mm to get into the air channel.
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
2.3.4 Evaluation of the Samples 1 Check that the strip is tight and no transversal air channels are present
This picture shows a good seal, in which the LS induction heating setting is at acceptable values.
Good seal
3 This picture shows a good seal, in which the LS induction heating setting is at acceptable values.
Good seal
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Critical points are where the LS and the TS meet, and on the top and bottom creases.
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
4 The Red ink flows straight in the air channel and there are no deviations.
Good seal
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This picture shows a seal in which the ink flows in the air channel showing deviations that are not compromising package integrity yet.
Good seal
6 This picture shows a seal in which the deviations of the ink in the air channel are worsened making a leaking channel.
Defective seal
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5
2 Longitudinal Seal (LS/SA)
2.3 Longitudinal Seal - Red Ink Injection
7 This picture shows wrinkles and transversal air channels running across the LS. This is typical of the LS made by Induction Heating when the settings of the inductors are too high.
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3 Opening Devices
Methods:
Methods: MTD 1211 - Opening Device PullTab and FlexiCap Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used.
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Reference Documents Previous version, MTD 1211, issued by Sara Davolio, date 1996/11/27.
Table of Contents
3 Opening Devices
3.1 Opening Devices - General Information . . . . . . 3 - 5 3.2 Opening Devices - PullTab (MTD 1211) . . . . . . . 3 - 6 3.2.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 6
3.2.2
Preparation of the Samples. . . . . . . . . . . . . . . . . . 3 - 7
3.2.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 8
3.2.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . . 3 - 9
3.3 Opening Devices - FlexiCap (MTD 1211) . . . . . . 3 - 11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 11 3.3.1.1
FlexiCap top crease faults . . . . . . . . . . . . . . . . . . 3 - 13
3.3.1.2
FlexiCap longitudinal crease faults . . . . . . . . . . . 3 - 15
3.3.1.3
FlexiCap injection faults . . . . . . . . . . . . . . . . . . . . 3 - 17
3.3.1.4
Underfilled FlexiCap . . . . . . . . . . . . . . . . . . . . . . . 3 - 19
3.3.2
Preparation of the Samples. . . . . . . . . . . . . . . . . 3 - 20
3.3.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 21
3.3.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . 3 - 23
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3 Opening Devices
Methods:
3 Opening Devices
3.1 Opening Devices - General Information
3.1 Opening Devices - General Information The methods reported in this section are aimed at assessing the integrity of TPCA opening devices. PullTab and FlexiCap are two opening devices made in the filling machine. To allow these applications, the packaging material is punched and sealed again to restore integrity during the production cycle. The integrity of the PT application is ensured by the PEP strip (Inner Patch) sealed in the inside of the package, which isolates the product from paperboard fibres around the punched hole. For the FlexiCap, the PE and the MasterBatch granulate of the cap is melted and injected so that it is sealed to the inner PE layer of the packaging material, restoring the microbiological barrier.
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Opening such as StreamCap and SpinCap are applied over a PLH (Pre Laminated Hole) after the package leaving the Filling Machine and not treated in the manual. Check also section Pre-Laminated Hole at page iii-11.
PullTab
FlexiCap
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3 Opening Devices
3.2 Opening Devices - PullTab (MTD 1211)
3.2 Opening Devices - PullTab (MTD 1211) 3.2.1 Introduction This document describes a method to evaluate the integrity of the PullTab (PT) opening by means of the leakage detection fluid (Red Ink). A PT opening consists in a hole punched in the packaging material (3). The hole is then closed on the outside by an aluminium Tab (1) and on the inside by a multi-layer plastic strip (Inner Patch, IP) (4). Tab and Inner Patch are sealed together before forming the package.
The overall PT quality is also given by PullTab position, Tab folding and Sealing/Heat pattern.
1 3 4 5 TBA, TCA and TPA Family packages
1
2 3 4
5 TPA Portion packages
1 2 3 4 5
Tab Outer patch Packaging material Inner patch Air gap
(Cont'd)
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An air gap (5) is present around the entire perimeter of the hole. This free space prevents packaging material fibres from coming into contact with the inner patch (4) since it could eventually damage or perforate it. The Inner Patch seals the punched hole, isolating the product from the rest of the packaging material layers. This restores the microbiological barrier and ensures package integrity.
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In TPA portion packages, a plastic unilateral strip (Outer Patch, OP) (2) is applied onto the external surface of the packaging material before punching the hole, to cover the paperboard fibres when the PT is opened for consumption.
3 Opening Devices
3.2 Opening Devices - PullTab (MTD 1211)
3.2.2 Preparation of the Samples 1 Select a suitable number of packages according to the level of accuracy needed. Cut the packages into two halves with a cutter; only the top parts will be used for the test.
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Rinse the package samples and let them dry in a well ventilated area or using compressed air.
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3 Opening Devices
3.2 Opening Devices - PullTab (MTD 1211)
3.2.3 Procedure 1 Apply red ink over the inner surface of the PT hole with a plastic pipette, covering the inner patch completely. Leave the red ink inside the package for at approximately 5 minutes. Remove the excess of red ink with the pipette.
Clean the inside of the package with a dry paper towel or let it dry thoroughly in a well ventilated area. Note! Flushing with water might give problems if water is not carefully dried before unfolding the flaps and splitting the packaging material.
3 Flatten the package by opening the flaps. Carefully, starting from the LS overlap, split the paperboard and remove the outer layer. Continue peeling the package. Some paperboard will come off together with the outer layer of PE and the PT will open up.
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Note! Do not pour red ink out of the package as this could lead to false positive reading.
3 Opening Devices
3.2 Opening Devices - PullTab (MTD 1211)
4 Continue peeling the package. Some paperboard will come off together with the outer layer of PE and the PT will open up. Note! If the ink is still in the package before performing this operation, artifact defects might be created.
3.2.4 Evaluation of the Samples
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The PullTab sealing is good if there are no red ink spots on the paperboard layer around the PullTab hole.
Good application
2 The PullTab sealing is defective if there are red ink spots on the paperboard layer around the PullTab hole.
Defective application
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1
3 Opening Devices
3.2 Opening Devices - PullTab (MTD 1211)
3 This is typical problem due to confetti removal failure. The confetti waste box and waste tube are filled up and their presence in the system create this defect in the application.
Defective application
A
If the PE residue is completely missing, the pressure or heat, during application, was too high and Package Integrity can be affected.
A TBA
If the PE residue is too wide, pressure or heat, during application, was too low and pouring performances can be affected. Note! TPA packages, having a wider hole might show more residue than TBA packages. If ReCap is present the cap helps in getting improved pourability. Note! Refer to the Filling Machine Operation Manuals for related measures A.
A A TPA
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Check if there is a residue of PE all around the PT hole, measure A (see table below). This residue corresponds to the unsealed area of the strip, it is to say the air gap.
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4
3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3.3 Opening Devices - FlexiCap (MTD 1211) 3.3.1 Introduction This chapter describes how to evaluate the quality of the FlexiCap openings. FlexiCap Opening, like PT Opening, consists in a hole which is punched in the packaging material; the hole is then hermetically closed on the outside by a cap which is injection-moulded directly on to the packaging material before forming the packages. The FlexiCap integrity is tested by the leakage detection fluid (red ink), by visually checking the cap and testing the FlexiCap opening force. • • •
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•
faults which are a result of the positioning of the punched hole, faults which are a result of the positioning of the FlexiCap, faults which are a result of a combination of the positioning of both the punched hole and the FlexiCap, faults which are a result of the setting of the moulding tools and/or injection system.
In general, FlexiCap faults are: • result of the hole and FlexiCap positioning, • •
combination being correctly aligned to each other but incorrectly positioned on the packaging material, inaccurately set moulding tools and/or injection system.
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FlexiCap faults can be categorized into four distinct groups:
3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
1 2 3 4 5 6 7 8
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Lid Membrane Hinge Dog bone Injection Point PullTab Tamper evidence Punched hole edge
9 10 11 12 13 14 15 16
Spider leg Leg Membrane support Pouring lid Inside sealing area Knife Stepped membrane Membrane support rib
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FlexiCap Terms
3 Opening Devices FlexiCap top crease faults
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Delamination If the FlexiCap is positioned too close to the top crease there is an increased risk of delamination of the packaging material at the edge of the punched hole, see Figure 1. This will occur when the packaging material is being folded into the package shape in the filling machines final folder.
figure 1
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3.3.1.1
3.3 Opening Devices - FlexiCap (MTD 1211)
3.3 Opening Devices - FlexiCap (MTD 1211)
3 Opening Devices
Transportation damage - cracks in the rear If the FlexiCap is positioned too close to the top fin crease then there is a higher risk of FlexiCap damage during transportation. Typically the packages are stacked on top of each other and then distributed on pallets. If the FlexiCap is too close to the top fin crease, there is an increased load applied to the FlexiCap from the packages stacked above and this combined with the vibration and motion of the truck during transportation creates a fault in the FlexiCap.
figure 2
Cap in the Jaws Although this is a very uncommon problem, if the FlexiCap is positioned extremely close to the top fin crease there is a risk of the FlexiCap being trapped between the inductors of the filling machines jaw system.
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Generally this appears as a crack at the rear of the FlexiCap, see figure 2.
3.3.1.2
3.3 Opening Devices - FlexiCap (MTD 1211)
FlexiCap longitudinal crease faults
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Broken membrane If the FlexiCap is positioned too far over the longitudinal crease there is an increased risk of the membrane being broken at the front of the FlexiCap, see figure 3. This happens when the folding flaps of the jaw system grip the packaging material to keep the tube within design. It is acceptable for the folding flaps to pinch the end of the FlexiCap tab, but if the FlexiCap is positioned too far over the longitudinal crease the folding flaps will pinch too much of the FlexiCap and as a result the membrane can be broken.
figure 3
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3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3 Opening Devices
Positioning impact If the FlexiCap is positioned too far from the longitudinal crease both pouring performance and closure after opening performance are affected and tamper evidence might get broken during package forming in the line.
This is because the edge of the package side panel (longitudinal crease) supports the FlexiCap, but if the FlexiCap is positioned too far from this extra support, cracks in the front of the FlexiCap can form under the pouring lip, see figure 4.
figure 4
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Transportation damage - crack in the front If the FlexiCap is positioned too far in from the longitudinal crease, occasionally cracks are formed in the front of the FlexiCap, normally the cracks appear after and as a result of transportation and distribution of the packages.
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The FlexiCap has been designed to be moulded over the edge (longitudinal crease). Pouring performance is also affected by FlexiCap positioned far from the side panel. The longitudinal crease gives the proper support to allow reclosability.
3 Opening Devices 3.3.1.3
3.3 Opening Devices - FlexiCap (MTD 1211)
FlexiCap injection faults Overfilled FlexiCap The amount of plastic used in each FlexiCap is regulated by adjusting the stroke of the injection cylinder, see the DIMC Multi maintenance manual Injection system - set cylinder for more details.
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If too much plastic is injected, splashes of plastic will be visible around the inside of the FlexiCap, see figure 5.
figure 5
(Cont'd)
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3.3 Opening Devices - FlexiCap (MTD 1211)
3 Opening Devices
(Cont'd) The first FlexiCaps produced can be overfilled. This is due to a change in the characteristics of the plastic left in the injection system from the previous production, which allows more plastic to be injected. This is normal and no corrective action is required.
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figure 6
figure 7
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If the FlexiCaps have a fin along the top of the lid, this too could be the result of too much plastic being injected. But it is more likely to be a small amount of cured plastic trapped between the two halves of the lower tools stopping the two halves of the lower tools from closing completely. See figure 6 and 7.
3 Opening Devices 3.3.1.4
3.3 Opening Devices - FlexiCap (MTD 1211)
Underfilled FlexiCap
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Underfilled FlexiCaps are a direct result of an incorrectly set injection system, see figure 8.
figure 8
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3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3.3.2 Preparation of the Samples 1 Select a suitable number of packages according to the level of accuracy needed. Note! At least 1 package produced by each moulding station must be sampled and checked.
Cut the packages into two halves with the scissors. Only the top parts will be used for the test. Rinse the package samples and let them dry in a well ventilated area or using compressed air.
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If the test is applied during troubleshooting take a tray of packages in which at least 1 appears defective.
3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3.3.3 Procedure FlexiCap Integrity Check
1 Note! If the check is being carried out after a packaging material splice check the FlexiCap forming as described in the FlexiCap forming Apply red ink to the inside of the package in the area indicated in the illustration with a plastic pipette, covering the FlexiCap completely. Leave the red ink inside the package for at approximately 5 minutes. Remove the excess of red ink with the pipette.
Note! Do not pour red ink out of the package as this could lead to false positive reading.
2 Break the tamper evidence of the FlexiCap and lift it just enough to see inside. Check that the red ink has not passed through the membrane (in the area indicated on the illustration). If the red ink has passed through the membrane, corrective action shall take place.
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Wait for the ink to completely dry.
3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3
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Carefully peel off the outer layer of PE starting from the LS overlap. Some paperboard will come off together with PE.
3 Opening Devices
3.3 Opening Devices - FlexiCap (MTD 1211)
3.3.4 Evaluation of the Samples 1 Check for any red spots around the application. Absence of red spots indicates that the FlexiCap application is good.
2 Red spots indicate that the FlexiCap application is defective. Note! Problems with FlexiCap sealing may result in unsterile packages and corrective action shall take place.
Defective application
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Good application
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3 Opening Devices
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3.3 Opening Devices - FlexiCap (MTD 1211)
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4 Package Integrity
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4 Package Integrity
Methods: MTD 1203 - Package Integrity - Conductivity test Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD 1203, issued by Sara Davolio, date 1996/04/20.
Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD1207, issued by Sara Davolio, date 2002/03/05.
MTD 1204 - Package Integrity - Red Ink test Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details. Tools and Chemicals Refer to section B.2 Tools and Equipment, page Appendix-6 for details on the tools used. Reference Documents Previous version, MTD1204, issued by Sara Davolio, date 1996/04/20.
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Personnel This method must be performed by Qualified personnel. Refer to section Personnel Requirements, page i-5 for details.
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MTD 1207 - Package Integrity - Copper test
Table of Contents
4 Package Integrity
4.1 Package Integrity - General Information . . . . . . 4 - 5 4.2 Package Integrity - Conductivity Test (MTD 1203) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 6 4.2.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 6
4.2.2
Preparation of the Samples. . . . . . . . . . . . . . . . . . 4 - 7
4.2.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 8
4.2.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . . 4 - 9
4.3.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 10
4.3.2
Preparation of the Samples. . . . . . . . . . . . . . . . . 4 - 11
4.3.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 12
4.3.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . 4 - 14
4.4 Package Integrity - Red Ink Test (MTD 1204) . 4 - 15 4.4.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 15
4.4.2
Preparation of the Samples. . . . . . . . . . . . . . . . . 4 - 16
4.4.3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 17
4.4.4
Evaluation of the Samples . . . . . . . . . . . . . . . . . 4 - 18
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4 Package Integrity
4 Package Integrity
4.1 Package Integrity - General Information
4.1 Package Integrity - General Information The present chapter reports test methods aimed at the microbiological barrier of a TPCA package. The microbiological barrier consists of the inner plastic layer, the Al- foil and the lamination layer between the Al- foil and the paper board. All three layers have to be broken before the microbiological barrier is lost. By definition, aseptic package integrity requires, beside sealing quality as described in the dedicated chapters, an intact microbiological barrier. The tests are: • Conductivity Test (MTD 1203) • •
Copper Test (MTD 1207) Red Ink Test (MTD 1204)
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Depth of defect
Conductivity Test
Red Ink Test
Copper Test
Tight Package
Corrective actions needed
A
X
X
X
NO
YES
B
X
-
X
YES
YES
C
X
-
X
YES
YES
D
-
-
-
YES
NO
3
B A 1 2 3 4 5 6
4
C
5
6
D 1
2
Inner layer (PE, m-PE) Adhesion layer Al-foil PE Lamination Paperboard Outer layer
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Defects are detected according to the table below.
4.2 Package Integrity - Conductivity Test (MTD 1203)
4 Package Integrity
4.2 Package Integrity - Conductivity Test (MTD 1203) 4.2.1 Introduction This chapter describes how to detect ruptures of the inner PE layer, which leave the Al-foil uncoated. The package is immersed in an electrolytic solution (salt solution). If there is a crack in the PE layers, an electrical contact is established between the electrolytic solution outside the package and the package content, which is measured by an ammeter (electrolytic tester).
Note! The only way to detect a blocked seal it is the manual Tear Down during Production. Conductivity test and Red ink test would not detect a blocked seal. To detect where the rupture is located, the test must be followed by the 4.3 Package Integrity - Copper Test (MTD 1207) or by the 4.4 Package Integrity - Red Ink Test (MTD 1204).
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Packages filled with fat products should not be checked with this method after storage, as the greasy components could create an insulating layer on the inside of the package, preventing current from circulating. Adopt the Red Ink Integrity test, instead.
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This method can be used for packages containing liquid products such as water, wine or fruit juice.
4 Package Integrity
4.2 Package Integrity - Conductivity Test (MTD 1203)
4.2.2 Preparation of the Samples 1 Cut all the selected packages in two halves with a sharp cutter or scissors.
2 Rinse the packages and wipe the cut edges thoroughly with a paper tissue or let them dry before testing; a wet edge might cause a false current deflection.
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Note! The best procedure is anyway to keep the package in one sample only.
4 Package Integrity
4.2 Package Integrity - Conductivity Test (MTD 1203)
4.2.3 Procedure 1 Put table salt (10 g per litre of water) into a plastic water basin. Fill a third of each package sample with the NaCl solution. Make sure the solution reaches the weak areas of the package, such as corners and creases. Put the sample carefully into the bowl, so that the outside corners are fully covered.
CAUTION Risk of false readings! Keep the package cut edges dry to prevent them from acting as a bridge and giving false deflections. Be careful not to scratch the inside of the packages with the electrodes. Note! The electrodes can be connected to the ammeter by wires, in order to facilitate the work.
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Dip the positive probe (Red) of the ammeter inside the package and the negative one (Black) outside of it, into the NaCl solution.
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Note! The black probe (negative) has to be placed in the water, the red probe (positive) in the package sample.
4 Package Integrity
4.2 Package Integrity - Conductivity Test (MTD 1203)
4.2.4 Evaluation of the Samples
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Read the deflection of the ammeter: • If the reading is 0 µA, the sample has no ruptures in the internal PE coating; (negative samples). • If the ammeter reading is unsteady and greater than 0 µA, wipe the edge once more and make a new reading; if still unsteady, let the sample dry. • If the deflection is quick and steady and the reading is greater than 0 µA, it means that there is contact to the Al-foil (i.e. a hole on the inner PE layers). Those samples shall be submitted to further investigations, (positive samples). Note! A reading below half scale is almost always a wet paper edge.
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4.3 Package Integrity - Copper Test (MTD 1207)
4 Package Integrity
4.3 Package Integrity - Copper Test (MTD 1207) 4.3.1 Introduction This document describes a method to locate ruptures in the inner layers of the Tetra Pak Carton Ambient packages. Ruptures in the inner PE layers can be detected by the conductivity test (MTD 1203). The package is immersed in an electrolytic solution (i.e. salt solution). In case of a crack in the PE layers, which leave the Al-foil uncovered, an electrical contact is established between the electrolytic solution outside the package and the package content.
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If some copper solution is poured into the package, the copper oxide solidifies in the area of the cracks when a copper tester is used, allowing to locate the fault.
4 Package Integrity
4.3 Package Integrity - Copper Test (MTD 1207)
4.3.2 Preparation of the Samples 1 Cut all the selected packages in two halves with a sharp cutter or scissors.
2 Rinse the packages and wipe the cut edges thoroughly with a paper tissue or let them dry before testing; a wet edge might cause a false current deflection.
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Note! The best procedure is anyway to keep the package in one sample only.
4 Package Integrity
4.3 Package Integrity - Copper Test (MTD 1207)
4.3.3 Procedure Note! If the Red ink test (MTD 1204) is going to be performed on the packages, do it before the copper test. The copper test can cause an enlargement of the cracks in the packaging material, compromising the results of the ink penetration.
1 Put some NaCl solution (approx. 10%) into a plastic water basin.
Refer to Use of the Electrolyte Copper Tester, page Appendix-12, when using the Tester.
2 Press the Push button for approximately four seconds to turn on the tester. If the ammeter shows a current deflection over 50 µA, there might be the presence of a crack in the inner layer up to the Al-foil.
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Put the red electrode into the sample package and the black one in contact with the salt solution.
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Put some copper solution into the sample package, to cover corners and creases, and dip it carefully into the basin, so that it is steady.
4 Package Integrity
4.3 Package Integrity - Copper Test (MTD 1207)
3
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4 Move the red electrode around the inner corners of the packages for approximately 3 minutes; the copper will deposit on the cracks, making them visible. Mark the areas of deposition with a permanent marker. Repeat the test with all the packages, on both halves.
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Press the button Push once again. Electrolysis starts. The red LED lights up.
4 Package Integrity
4.3 Package Integrity - Copper Test (MTD 1207)
4.3.4 Evaluation of the Samples 1 After the copper test has been performed, rinse the sample packages with water. Let them dry thoroughly; use compressed air to speed the process. Unfold the flaps and peel off the outer layers.
2
3
5
3
6
If no red ink is found on the packaging material, the contact was due to a rupture of the plastic layers up to the Al-foil (3) (cases B, C or D).
A
D 7 1 2 3 4 5 6 7
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4
1 Inner layer (PE, m-PE) Adhesion layer Al-foil PE Lamination Paperboard Outer layer Copper deposition
2
If red ink spots are visible, in correspondence of a copper deposition area (7), a rupture of the plastic layers and Al-foil occurred, causing a defect (case A). Count the number of packages with exposed Al-foil, packages with red ink failures that compromise the package integrity and the total number of tested packages. Record the data.
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B
C
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Look for red ink spots on the paperboard.
4 Package Integrity
4.4 Package Integrity - Red Ink Test (MTD 1204)
4.4 Package Integrity - Red Ink Test (MTD 1204) 4.4.1 Introduction
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An aseptic package is conventionally defined as leaking when Red Ink penetrates the coating layers and stains the paperboard. According to this definition, a package is defective when it is positive to the Red Ink Test, since all the microbiological barriers performed by the Al-foil and inner PE layers are broken: integrity is therefore not guaranteed.
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4 Package Integrity
4.4 Package Integrity - Red Ink Test (MTD 1204)
4.4.2 Preparation of the Samples 1 During troubleshooting Cut out a hole in the front panel of the package. This allows to investigate the package as a whole, identifying the defective areas in an accurate way.
During Production or After Production Laboratory checks Cut the packages in two halves using a cutter. Note! The best procedure is anyway to keep the package in one sample only.
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Note! TFA packages should be cut into halves, making sure not to cut on damaged spots.
4 Package Integrity
4.4 Package Integrity - Red Ink Test (MTD 1204)
4.4.3 Procedure 1 Apply red ink over the critical points of the package, such as corners, TS, crosses. Leave the red ink inside the package for approximately 5 minutes. Remove the excess of red ink with the pipette.
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2 Clean the inside of the package with a dry paper towel or let it dry thoroughly in a well ventilated area.
3 Once samples are dry, unfold the flaps and carefully peel off the outer layer of PE starting from the LS overlap. Some paperboard will come off together with the PE. Note! If ink is still present in the package, leakage can be caused by opening the flaps and breaking the inner PE layer.
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Note! Do not pour red ink out of the package as this could lead to false positive reading.
4 Package Integrity
4.4 Package Integrity - Red Ink Test (MTD 1204)
4.4.4 Evaluation of the Samples 1 Check for any red ink spots on the paperboard layer on the corners, TS, and crosses areas. Any red ink leakage corresponds to a defect in the package.
Defective
TBA and TPA packages can be affected by fin tears in the top due to interactions between the PM and folding flaps. TWA packages are affected by fin tears in the bottom (since the folding flaps act on the bottom). Check for any red ink spots on the fins. Any red ink leakage corresponds to a defect in the package. TWA package shown
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Defective
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Fin tear can develop into integrity defects.
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Fin tearing
4 Package Integrity
4.4 Package Integrity - Red Ink Test (MTD 1204)
2 If the red ink spot is larger on the peeled external layer than on the package side, it means that the ink has leaked from the OUTSIDE of the package to the INSIDE.
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1
2
1 2 3 4 5
Larger red ink spot PM external layer Split paperboard Smaller red ink spot PM internal layers
3
4 5
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This is NOT an integrity defect but simply and artifact by applying the procedure. See diagram.
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4.4 Package Integrity - Red Ink Test (MTD 1204)
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5 Package Forming
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The methods reported in this section are additional checks which are not aimed at assessing package integrity, but other important aspects of the packages such as flap sealing, data printing, weight. They are included here to give a complete picture of what is a good package, also from appearance’s point of view.
Table of Contents
5 Package Forming
5.1 Package Forming. . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 Date Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 Flap Sealing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5 Crease lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 6 LS Overlap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 7
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Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 7
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5 Package Forming
5 Package Forming
5.1 Package Forming
5.1 Package Forming Note! The machine OMs always report an updated and exhaustive version of package appearance and forming checks.
Date Printing Check the date and code printing.
Weight TechPub_2614345_0103 - 05_2712261_01_en.fm
Weigh the packages. Record their weight and weight deviations. After setting, pick out new packages and check them.
Flap Sealing Unfold the flaps and check that they are properly sealed. On the bottom flaps the heat should not be directed on the TS. Burnt marks might impact on package integrity.
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If necessary, stop the filling machine and adjust the date printing according to the instructions supplied with the printer.
5 Package Forming
5.1 Package Forming
Crease lines
1
Lift the package top or bottom fin (1).
fig.1 Bottom view of package
2
2
Note! To correct check crease lines alignment it is important to lift the flaps, since closed flaps might give indication of wrong set of creases lines, but due to package folding. Check the position of the preformed crease lines (2).
fig.1
The position is acceptable if
2
2
fig.2
the creases are opposite one another (fig.1) either parallel (fig.2) or at an angle (fig.3).
•
the preformed crease lines are not opposite one another (fig.5 and 6).
If there are any defects, corrective actions should be taken.
fig.3
2
2
fig.4
2 fig.5
2
After adjustment, pick out new packages and check them. Note! To correct assess crease lines alignment it is important to lift the flaps, since closed flaps might give indications of wrong set of creases lines, but they are due to package folding in the Final Folder Unit, as shown the picture below.
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The position is not acceptable if
2
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•
5 Package Forming
5.1 Package Forming
LS Overlap With the aid of a vernier calliper check the width of the packaging material overlap, distance B.
B
If the overlap is out of the range indicated, corrective actions should be taken.
Surfaces
fig.1
Cut two opposite corners (fig.1) and empty the content of the package (fig.2) fig.2
Cut transversally the front panel of the package, from the lower cut corner to the opposite one (fig.2 and 3). Split the TS apart and open the package (fig.4). Rinse and dry the package with compressed air from the filling machine. Check the outside and inside surfaces of the package for scratches.
fig.3
Inside deep scratches might cause package integrity problems. If there are any defects, corrective actions should be taken. fig.4
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Note! Refer to the Filling Machine Operation Manuals for related measures B.
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5 Package Forming
5.1 Package Forming
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Appendix A: Flowcharts and Troubleshooting
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Appendix - 2
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Appendix A:Flowcharts and Troubleshooting
Appendix A:Flowcharts and Troubleshooting
Table of Contents
A.1 Operator Checks . . . . . . . . . . . . . . . . . . Appendix - 5 A.1.1
Checking scheme. . . . . . . . . . . . . . . . . . . Appendix - 5
A.1.2
Flowchart of the Production Quality Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 7
A.2 Laboratory QC Checks . . . . . . . . . . . . . Appendix - 9 A.3 Products with Fibres Checks . . . . . . . Appendix - 10 A.4 Troubleshooting . . . . . . . . . . . . . . . . . Appendix - 12 Homogeneous (Water-based) Products . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 13
A.4.2
Viscous and Fatty Products . . . . . . . . . Appendix - 14
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A.4.1
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Appendix - 4
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Appendix A:Flowcharts and Troubleshooting
Appendix A:Flowcharts and Troubleshooting
A.1 Operator Checks
A.1 Operator Checks A.1.1 Checking scheme The Checking Scheme, present in the OM of the filling machine, describes the recommended sequence of checks to be done on the packages. The Checking Scheme table explains:
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•
the event which it is recommended that the package checks are performed immediately after, e.g. Production Start (1). the number of packages needed for checks according to which event has prompted the package checks (2).
• • •
the number of packages on which to perform the individual checks (3). the check to be performed (4). the page number of the check instructions (5).
•
to mark the check box when the check has been completed (6)
Note! For some checks, the number of packages checked depends on the number of jaws of the filling machine. This variable is identified as X. X is equal to the number of jaws of the FM (e.g. 2 jaws in TBA/19 and TBA/21, and 10 jaws in Tetra Pak A3/Speed and TBA/22). X+1 means that the number of packages to be checked are equal to the number of jaws plus one package. Refer to the specific machine OM for instructions on how to select and mark the packages for quality checks. Extract from the Checking Scheme schedule
2 3
Date Print
1
3
1
Production Start
4
page 123
5
6
(Cont'd)
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•
Appendix A:Flowcharts and Troubleshooting
A.1 Operator Checks
(Cont'd) Here below an example of Checking Scheme as you can find it in the OM. These checks can be carried out by the operator in the machine area, during Production. These checks are Filling Machine and PullTab unit dependent due to number of jaws (X variant) of the FM or/and PullTab unit with single or double index (Y variant). Please refer to the machine OM as detailed reference.
X
Date print
Weight
X
1
X
TS X
X
After a raw material splice
1
After a LS strip splice
Y
After a patch or tab strip splice
Date print
Weight
TS
X
TS (Accurate)
X (Accurate)
1
Shape & design
1
Shape & design
Y
Tab position
Y
Tab position*
1
Flap sealing
1
Flap sealing
TS
1
Crease lines
1
1
Overlap
1
1
Surfaces
1
Y
Tab position
Crease lines Overlap
Surfaces
Y
Hole position
Y
Hole position
Y
Hole position
Y
Patch & tab sealing
Y
Patch & tab sealing
Y
Patch & tab sealing
1
LS/SA
Appendix - 6
1
LS/SA
1
LS/SA
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Production start
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X+1
Appendix A:Flowcharts and Troubleshooting
A.1 Operator Checks
A.1.2 Flowchart of the Production Quality Checks The Flowchart of Production Quality Checks displays:
• •
the checks to be performed in the sequence described in the checking scheme table (1) the type of check (2) the necessary actions (if any) to be taken depending on the result of the completed check (3).
Note! For some checks, the number of packages checked depends on the number of jaws of the filling machine. This variable is identified as X. X is equal to the number of jaws of the FM (e.g. 2 jaws in TBA/19 and TBA/21, and 10 jaws in Tetra Pak A3/Speed and TBA/22). X+1 means that the number of packages to be checked are equal to the number of jaws plus one package. Refer to the specific machine OM for instructions on how to select and mark the packages for quality checks.
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Extract from Flowchart of operator quality checks
2 1
Flap Sealing
1
No OK?
TPOP Setting
3
Yes
1
TS Rough
1
2 No
OK?
Call a Technician
Stop Production
Yes
3
3
= Legal requirement related check = Package integrity related check = Package appearance and line efficiency related check
(Cont'd)
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•
Appendix A:Flowcharts and Troubleshooting
A.1 Operator Checks
(Cont'd) Here below an example of Production Quality Check Flowchart as you can find it in the OM. These checks can be carried out by the operator in the machine area, during Production. These checks are Filling Machine and PullTab unit dependent due to number of jaws (X variant) of the FM or/and PullTab unit with single or double index (Y variant). Please refer to the machine OM as detailed reference. Date print 1
no Ok?
Stop Production
call a technician
1
Crease lines
yes Weight
no
1
Machine setting
Ok?
TS (rough)
Ok?
Stop Production
call a technician
1
no
Stop Production
call a technician
Stop Production
call a technician
Surfaces
yes
Ok?
TS (accurate) no Ok?
yes Stop Production
Machine setting
1
LS/SA
no
yes
Ok?
Shape and design no Ok?
yes
Machine setting
continue Production
additional
X+1 packages to
yes 1
call a technician
yes no
1
Stop Production
Overlap
yes
X
no
yes
Laboratory QA checks
Flap sealing
Ok?
no
Machine setting
yes
Appendix - 8
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Ok?
X
Machine setting
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X
no Ok?
Appendix A:Flowcharts and Troubleshooting
A.2 Laboratory QC Checks
A.2 Laboratory QC Checks These checks must be carried out on regular basis by qualified personnel, in an area appropriately equipped. This allows to constantly monitor the quality of the packages.
Conductivity X test
MTD 1203
1
LS by red ink injection
MTD 1202
yes test ok?
record results
no test ok?
no
defect found
corrective actions
yes test ok?
record results
X
Alu-foil TS cracks
MTD 1210
X
Dissolve packages
MTD 1208
yes
urgent check?
Leakages ? by red ink
MTD 1204
no defect found
corrective actions
no
method 2: dissolving in alkaline solution
method 1: dissolving in acid solution
record results
obtain samples
X
MTD 1208
Heat pattern yes
X
MTD 1208
TS integrity by red ink
yes test ok?
record results
no defect found
corrective actions
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yes
Appendix A:Flowcharts and Troubleshooting
A.3 Products with Fibres Checks
A.3 Products with Fibres Checks These checks can be of help to investigate the behaviour of products containing fibres. Due to the fact that the Transversal Sealing takes place in the product flow, fibres can be trapped in the TS (usually bottom seal for TPA, TBA, TCA and TFA packages, top seal for TWA packages), causing unsterility during storage and transportation. By definition, the filled product should be homogenous, i.e. no particles must be retained on a sieve 0.6 span.The only non-homogeneous products accepted by TPCA are citrus juices with a maximum fibre content of 5%. Fibres hardness is a parameter that can highly influence performance even though it is not measurable and specified.
Description
Packaging Lines
HVA (High Viscosity Aseptic) kit
Helps the product run through the filling system avoiding valve clogging
TBA/8 TBA/19
Special packaging material TBA/lk-25 and TBA/lk-36
The LLDPE film improves packing of hard particles
All except TBA/3
Modified counter pressure rubber dollies in combination with modified jaw system settings
Help to free the sealing area from particles
TBA/3 TBA/8 TBA/9 TBA/19 TBA/21
Non-trapped fibre Upper package
Top seal
Lower package
Bottom seal
Trapped fibre
(Cont'd)
Appendix - 10
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Special equipment and packaging material have been designed to reduce the risks of defective seals when packing fibrous products, see table below. For further information, refer to the TPCA Sealing Technology and Food Technology Departments.
Appendix A:Flowcharts and Troubleshooting
A.3 Products with Fibres Checks
(Cont'd) The following flowchart represent part of a test procedure which should be carried out on a representative batch of at least 6000 packages to get reliable results. The procedure should be performed before and after full distribution (i.e. transportation).
Conductivity MTD 1203 test. 300
no
defective packages
test ok?
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Dissolve 100 packages
no
fibres are not a problem
fibres in TS?
?
TS integrity by red ink
no test ok?
fibres are a problem
yes
yes
Dissolve packages fibres may be a problem fibres in TS?
no
fibres are not a problem
yes fibres may become problem
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yes
Appendix A:Flowcharts and Troubleshooting
A.4 Troubleshooting
A.4 Troubleshooting These checks take place during troubleshooting to investigate if the unsterility is due to package integrity. Care in every step of the evaluation is important since the methods are destructive and packages will not be available for further checks afterwards. Package forming and data printing should be analysed and recorded since they may add relevant information to find the cause of unsterility. The procedure is slightly different for homogeneous (water-based) products (e.g. water, fruit juice) and viscous or fatty products (e.g. cream, tomato sauce).
The overall troubleshooting procedure should be performed by: • FiSQA Officers • System Specialists • •
Appendix - 12
Senior Tetra Pak Field Service Engineers Senior Technical Support Staff.
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The optimal population to investigate consists of the blown package (which most likely will show also burst spots on the TS) and the packages produced close to it (most likely belonging to the same tray).
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The Conductivity Test is not effective with packages filled with fat products, as fat can create a layer which covers the defects and does not allow the flow of current. The Red Ink Test is performed instead. Products like cream might interact with packaging material causing a phenomenon called Environmental Stress Cracking.
Appendix A:Flowcharts and Troubleshooting
A.4 Troubleshooting
A.4.1 Homogeneous (Water-based) Products X
X
Weight, date print
perform A.1 Operator Checks
Conductivity test
MTD 1203
no test ok? yes
corrective actions
MTD 1210
no
defect found
test ok? yes
?
Leakages by red ink
MTD 1204
yes test ok?
X
MTD 1208
Dissolve packages
no yes
defect found
record results and corrective actions
no urgent check? * method 2: dissolving in alkaline solution
method 1: dissolving in acid solution get samples
X
X
Heat pattern
MTD 1208
TS integrity by red ink
MTD 1208
yes
no (*) Recommended
corrective actions
defect found
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test ok?
packages are integer
Appendix - 13
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X
Alu-foil TS cracks
Appendix A:Flowcharts and Troubleshooting
A.4 Troubleshooting
A.4.2 Viscous and Fatty Products Wash the inside of the packages with warm water and alcohol before performing the test, to take away as much product residue as possible, at ambient temperature. X
Date, Printing, Forming
X
Leakages by red ink
perform A.1 Operator Checks MTD 1204
Crease, Flap alignment
no
defect found
test ok?
corrective actions
MTD 1210
Alu-foil TS cracks
X
no
defect found
test ok?
corrective actions
yes
method 1: dissolving in acid solution
MTD 1208
Dissolve packages
X
yes
* method 2: dissolving in alkaline solution
no
urgent check?
obtain samples
X
X
packages are integer (*) Recommended
Appendix - 14
Heat pattern
MTD 1208
TS integrity by red ink
MTD 1208
no
yes test ok?
defect found
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corrective actions
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yes
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Appendix B: Tools and Chemicals
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Appendix - 1 (24)
Appendix B:Tools and Chemicals
Appendix - 2 (24)
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This chapter contains description and materials used in Package Integrity test methods.
Appendix B:Tools and Chemicals
Table of Contents
B.1 Area Requirement . . . . . . . . . . . . . . . . . Appendix - 5 B.2 Tools and Equipment . . . . . . . . . . . . . . Appendix - 6
B.3.1
Copper Solution . . . . . . . . . . . . . . . . . . . Appendix - 14
B.3.2
Dissolving Solutions . . . . . . . . . . . . . . . Appendix - 16
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B.3.3
B.3.2.1
Acid Dissolving Solution (very fast method) . . . . . . . . . . . . . . . . . . Appendix - 17
B.3.2.2
Acid Dissolving Solution (fast method) . . . . . . . . . . . . . . . . . . . . . . Appendix - 19
B.3.2.3
Alkaline Dissolving Solution (slow method) . . . . . . . . . . . . . . . . . . . . . Appendix - 20
Leakage Detection Fluid . . . . . . . . . . . . Appendix - 21 B.3.3.1
Red Ink . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 21
B.3.3.2
Blue Ink. . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 23
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B.3 Preparation of Chemicals . . . . . . . . . . Appendix - 13
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Appendix B:Tools and Chemicals
Appendix B:Tools and Chemicals
B.1 Area Requirement
B.1 Area Requirement An adequately equipped area must be available to carry out integrity tests. The area must be ventilated and with good illumination.
3 2
3
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A fume extractor is needed for the preparation of the dissolving solutions. Running water is needed. Compressed air can be useful.
4 5
1
6
1 2 3 4 5 6
Conductivity Water Magnifying lenses Compressed air Microscope Dissolving station
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Appendix - 5 (24)
B.2 Tools and Equipment
Appendix B:Tools and Chemicals
B.2 Tools and Equipment
Picture
Supplier and code
Used in
Rolling ball point pen (felt tip pen (red)
Any
2.2.4-1 Rolling ball point pen test (after mechanical tear down)
Permanent pen
Any
All
Scissors
Fiskars
All
No. 9451-7097
Pinking scissors
Fiskars No. 9445-7097
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208) 1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
Cutter
Any
All
Note! Snap off blades are not used in many food industries. Refer to local regulation. Paper towels
Appendix - 6 (24)
Any
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All
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Name
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Here you have a list of tools and equipment used in Package Integrity Methods, with reference to the specific method in which they are needed and item code.
Appendix B:Tools and Chemicals Picture
Supplier and code
Used in
Light source
Any
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
Beakers
Any
B.3 Preparation of Chemicals
Pipettes
Any
B.3 Preparation of Chemicals
Water tray
Any
4.2 Package Integrity - Conductivity Test (MTD 1203)
Note! Cat litter tray (HDPE) can work very well.
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4.3 Package Integrity - Copper Test (MTD 1207)
Appendix - 7 (24)
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Name
B.2 Tools and Equipment
Picture
Supplier and code
Used in
Disposable syringe
needle ø 0.4-0.5 mm 2.3 Longitudinal Seal - Red Ink Injection
Gloves
Any
All
Safety goggles
Any
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208) B.3.1 Copper Solution
Tongs
Any (wooden material is preferable)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
Appendix - 8 (24)
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Name
Appendix B:Tools and Chemicals
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B.2 Tools and Equipment
Appendix B:Tools and Chemicals Picture
Supplier and code
Used in
Abrasive sponges
Any
1.4 Transversal Seal - Al-Foil Cracks (MTD 1210)
Magnifying lamp with in-built light
Any (this model is PEAK)
1.2 Transversal Seal - Tearing (MTD 1201)
Magnifying lenses
Peak
1.2 Transversal Seal - Tearing (MTD 1201)
Scale Lupe 10X No.2028 (78073-101) 1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208) Zoom Lupe 816 No.2044 Scale Lupe 10X No.1983 Light Lupe 15X TP No. 1326015
Stretch pliers
Tetra Pak
1.2 Transversal Seal - Tearing (MTD 1201)
No.78073-0101 Spare parts: Small spring No.566772 Big Spring No.566773
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Name
B.2 Tools and Equipment
B.2 Tools and Equipment
Name
Picture
Zonoscope
Appendix B:Tools and Chemicals Supplier and code
Used in
Tetra Pak
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
No.90243-0203
2.2 Longitudinal Seal (LS/SA) - Tearing (MTD 1202) PullTab positioning (OM)
No.90243-0110
Copper tester
Tetra Pak No.90459-0095
Water bath (bain-marie)
Dinkelberg No.ATH232319
Appendix - 10 (24)
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4.2 Package Integrity - Conductivity Test (MTD 1203)
4.3 Package Integrity - Copper Test (MTD 1207)
1.3 Transversal Seal - Dissolving and Red Ink (MTD 1208)
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Tetra Pak
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Ammeter
Appendix B:Tools and Chemicals
B.2 Tools and Equipment
Use of the Zonoscope The zonoscope is a polarizer which allows to better enhance and analyse the heat pattern of the LS. It does not give any indication on the quality of the sealing as far as distribution of pressure is concerned. When analysing the LS through the zonoscope, a different range of colours appear (dark blue and brown); this is due to the fact that the multilayer plastic of which it is made filters the light reflected from the Al-foil differently from the PE of the LS. The zonoscope has two sides. The one marked with a double circle is designed for TBA/K packaging material; turn this side facing upwards when analysing TBA/K. The other, marked with two lines, is intended for all the other packaging materials.
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The zonoscope is also widely used in PT applications to locate heat distribution.
TBA/lk
TBA/j
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Appendix - 11 (24)
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Either way, turning the zonoscope only changes the range of visible colours as light is filtered differently; therefore choose the side which better enhances the heat pattern under investigation.
B.2 Tools and Equipment
Appendix B:Tools and Chemicals
(Cont'd) Use of the Electrolyte Copper Tester CAUTION Risk of instrument damage. Never switch On the tester when the electrodes are in short circuit. Press the Push button for approximately four seconds to turn on the tester. The green LED 100µA lights up; the tester acts as voltage generator and detects the current loss between two liquids by the two electrodes. The display shows the value of the current deflection. Press the Push button once again to make the tester produce electrolysis acting as current generator. The red LED 100mA lights up. The display shows the value of the current circulating between the two liquids.
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To switch off the instrument manually, press the button Push for five seconds.
Appendix - 12 (24)
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The tester switches off automatically if there is no current circulating for 5 minutes.
Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
B.3 Preparation of Chemicals
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Name
Picture
Supplier and code
Used in
Copper solution
Preparation is required, see B.3.1 Copper Solution
4.3 Package Integrity Copper Test (MTD 1207)
Dissolving solutions (alkaline or acid)
Preparation is required, see B.3.2 Dissolving Solutions
1.3 Transversal Seal Dissolving and Red Ink (MTD 1208)
Leak detection fluid (red ink)
Can be ordered from Tetra Pak on TP No.90298-26 or prepared according to section B.3.3 Leakage Detection Fluid
1.3 Transversal Seal Dissolving and Red Ink (MTD 1208) 2.3 Longitudinal Seal Red Ink Injection 3.2 Opening Devices PullTab (MTD 1211) 4.4 Package Integrity Red Ink Test (MTD 1204)
Leak detection fluid (blue ink)
Preparation is required, see B.3.3.2 Blue Ink
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Not used in TPCA Package Integrity Methods
Appendix - 13 (24)
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Here you have a list of the chemicals used in Package Integrity Methods. Specific information about each chemical preparation and usage follow.
Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
B.3.1 Copper Solution Ruptures in the inner PE layers can be detected by the conductivity test (MTD 1203). The package is immersed in an electrolytic solution (i.e. salt solution). In case of a crack in the PE layers, which leave the Al-foil uncovered, an electrical contact is established between the electrolytic solution outside the package and the package content. If some copper solution is poured into the package, the copper concentrates in the area of the cracks when a copper tester is used, allowing to locate the fault. Ingredients • Cu2SO4.5H2O • • •
Emulsifying agent Distilled water HNO3 (concentrated 65%)
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Weight 100 g of Cu2SO4.5H2O in a plastic beaker.
2 Put a 1 l flask on the scale. Reset and add 0.5-1.0 g of any emulsifying agent using a pipette. Add 200 cm3 distilled water.
Appendix - 14 (24)
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Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
3 Mix the solution well with a magnetic agitator. Add the Cu2SO4.5H2O.
4 CAUTION Risk of personal injury! Use protective goggles and gloves when handling HNO3; put the acid into the solution, never the other way round Add 2.6 g of concentrated (65%) HNO3 with a syringe and mix for additional 5 minutes. The copper solution is ready. Store the solution in a glass bottle, filter or decant it after usage.
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Add 800 cm3 of distilled water while mixing. Make sure that the Cu2SO4.5H2O is completely dissolved.
B.3 Preparation of Chemicals
Appendix B:Tools and Chemicals
B.3.2 Dissolving Solutions These solutions can be used to dissolve the Al-foil and separate the internal polyethylene bag from the remainder of packaging material layers, when the Transversal Seal is under investigation. 1) Acid solution (very fast method), follow B.3.2.1 Acid Dissolving Solution (very fast method). 2) Acid solution (fast method), follow B.3.2.2 Acid Dissolving Solution (fast method). 3) Alkali solution (slow method), follow B.3.2.3 Alkaline Dissolving Solution (slow method).
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Note! Hydrofluoric Acid is used in local applications but fumes that give off are of health concern. (Cont'd)
Appendix - 16 (24)
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Refer to the 1.3.3-2 Dissolving of packages chart at page 1-22 for determine which type of solution is more suitable:
Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
(Cont'd)
B.3.2.1
Acid Dissolving Solution (very fast method)
Three different solutions are used, which we will call: 1) HCl 1:1 Solution, 2) HCl 1:3 Solution, 3) Neutralizing Solution.
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This method is very fast, therefore it is advisable when the results of the test are urgent. A fume extractor and a water bath are needed. Ingredients: • HCl (37% - starting solution as commercially available), • • •
Distilled water (1:1), CuCl2, Na2CO3 in cristals. (Cont'd)
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WARNING Risk of personal injury! Observe safety regulations when working with acids. Preparation and handling of HCl solutions must be carried out in a well-ventilated environment, as fumes may be given off. Always wear protective goggles and gloves. Use heat resistant beakers for preparation and storage. Exhausted chemicals must be disposed of in accordance with current regulations. Never poor water into the acid but always acid in water.
B.3 Preparation of Chemicals
Appendix B:Tools and Chemicals
(Cont'd) 1) HCl 1:1 Solution (Hydrochloric acid at 60° C) Note! The solution is prepared at room temperature but must be heated using a water bath at 60° C when in use. a) Dilute the concentrated HCl in distilled water (1:1) at room temperature. b) Add 1wgt % CuCl2 (e.g. 1 l. HCl, 1 l. distilled water, 20 g. CuCl2) at room temperature. c) Store the solution in a glass container with a glass lid when not in use. The bath can be filtered at room temperature and reused.
3) Neutralizing Solution (Sodium Carbonate at room temperature) Note! Bath 3 spoils very quickly. If the solution does not start to bubble as soon as the samples are immersed into it, prepare a new one. a) Prepare 10 wgt % solution of Na2CO3 in distilled water (e.g. 100 g. Na2CO3, 1 l. distilled water) at room temperature. b) Store the chemical in a glass container with a glass lid. The bath can be filtered at room temperature and reused.
Appendix - 18 (24)
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a) Dilute the concentrated HCl in distilled water (1:3). b) Add 0.5 wgt % CuCl2 (e.g. 250 cm3 HCl, 750 cm3 distilled water, 5 g.CuCl2); c) Store the chemical in a glass container with a glass lid. The bath can be filtered at room temperature and reused for several TS examinations.
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2) HCl 1:3 Solution (Hydrochloric acid at room temperature)
Appendix B:Tools and Chemicals B.3.2.2
B.3 Preparation of Chemicals
Acid Dissolving Solution (fast method) WARNING Risk of personal injury! Observe safety regulations when working with acids. Preparation and handling of HCl solutions must be carried out in a well-ventilated environment, as fumes may be given off. Always wear protective goggles and gloves. Use heat resistant beakers for preparation and storage. Exhausted chemicals must be disposed of in accordance with current regulations. Never poor water into the acid but always acid in water.
2) Neutralizing Solution. This method is fast, but slower than the method at B.3.2.1 Acid Dissolving Solution (very fast method). A fume extractor is needed.
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Ingredients: • • •
HCl (37% - starting solution as commercially available), Distilled water (1:1), Na2CO3 in cristals.
1) Acid Solution (Hydrochloric acid) Prepare an acid solution of HCl 30% (e.g. for 3 litres solution put 600 ml of water in a beaker and add carefully 2400 ml of HCl 37%). 2) Neutralizing solution Prepare 10 wgt% Na2Co3 in distilled water (e.g. 100 g Na2Co3 and add water until the solution is 1 litre.
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Appendix - 19 (24)
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Two different solutions are used: 1) Acid Solution,
Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
B.3.2.3
Alkaline Dissolving Solution (slow method) Ingredients: • •
Distilled water, NaOH
Prepare a 15% NaOH solution with distilled water. Stir the solution while adding water to the NaOH pellets. The solution warms up while adding water. Do not wait too long before using the solution or it may lose its efficiency.
Appendix - 20 (24)
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Note! CIP solution (normally 30% with no added cleaning agents) can be used after dilution 1:1
Appendix B:Tools and Chemicals
B.3 Preparation of Chemicals
B.3.3 Leakage Detection Fluid B.3.3.1
Red Ink Red ink is pure isopropanol based solution (99.5%), which has the characteristic of penetrating the small cracks and pinholes which can be present inside the package. The red colour is due to the addition of erithrosine, and it allows to visually detect the ink leakage, which simulates the penetration of microorganisms across the packaging material layer. Isopropanol has a high capillary action but does not interact, at room temperature, with the internal plastic layers of the package. Other solvents, like turpentine, would damage PE and therefore give false results, whereas Ethylic Alcohol (Ethanol) cannot be used worldwide due to special local regulations.
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1 Weight approximately 1.5 g of powder Erythrosin β.
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Appendix - 21 (24)
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Ingredients • Erythrosin β, sodium salt • Isopropyl alcohol (99.5 %, commercial purity)
B.3 Preparation of Chemicals
Appendix B:Tools and Chemicals
2 Mix the Erythrosin β with 1 l. of Isopropyl alcohol.
Filter the solution with a funnel covered with a paper towel, into a spare container. The red ink is ready to be used. Store the red ink in a convenient cabinet at room temperature, in a closed container to reduce evaporation.
Appendix - 22 (24)
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Shake well and leave to decant overnight.
Appendix B:Tools and Chemicals B.3.3.2
B.3 Preparation of Chemicals
Blue Ink Blue ink is a water based solution which is used to test the tightness of the external layer of the package (decor layer) to the penetration of water and humidity. Its characteristic colour is due to the addition of methylene blue. Blue ink cannot be used to assess microbiological tightness of the package at any level. It is not used for TPCA applications, but only for TPCC. The recipe is included here in case of interest. Ingredients • Methylene blue • Emulsifying agent • •
Ethanol (95%, commercial purity). Distilled water
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Weight 5 g of Methylene blue.
2 Warm up 1 l. distilled water in a heat resistant flask at about 45 °C. Dilute the Methylene blue into the distilled water. Mix the solution using a magnetic agitator.
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Appendix - 23 (24)
B.3 Preparation of Chemicals
Appendix B:Tools and Chemicals
3
Remove the flask from the agitator and add 200 cm3 Ethanol. Close tight and shake the solution well. Blue ink is ready. Store it at room temperature in a closed container to reduce evaporation.
Appendix - 24 (24)
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Add 5 cm3 of emulsifying agent (Polyoxyethylene (20) Sorbitan Mono-oleate) using a pipette and mix well with the magnetic agitator.
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Appendix C: Data Record
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Appendix - 1 (8)
Appendix C:Data Record Documenting and recording any changes related to package integrity tests are of the utmost importance at any stage of the product cycle, i.e. during Production and during laboratory checks. If unsterility problems occur and a troubleshooting procedure is needed, it is vital to trace back past production parameters and events to have a complete picture of the situation. In some countries, such as USA, Regulatory Agencies require the documentation of the defects detected and of all the related corrective actions.
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This section includes examples of forms which can be used as reference.
Table of Contents
Appendix C:Data Record
C.1 Production Package Recording Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 5 C.2 Laboratory Package Recording Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 6 C.3 Sample Collection Form . . . . . . . . . . . . Appendix - 7
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C.4 Troubleshooting General Data Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - 8
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Appendix - 4 (8)
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Appendix C:Data Record
ID
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event
LabCheckForm1.xls last update 13/09/2004
time
n.packs taken
EXAMPLE
Operator signature
Machine number
Machine type
Date
check box
Date print
check box
Weight
ID event
Production Package Recording Sheet
check box
setting
TS rough
Packages codes
PM P.O.
type
LS
check box
check box
check box
Shape and Flap sealing Crease lines design
Checks
type
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setting
TS accurate
Product temperature
check box
type
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check box
Overlap
P.O.
EX
X = not performed
PL
E
check box
setting
LS/SA
yes
Sara Davolio Monica Malagoli
no
lab. checks?
Note: packages tested as from event scheme on OM package checks
AM
check box
Surfaces
V = passed KO = not passed
legend
Appendix C:Data Record C.1 Production Package Recording Sheet
C.1 Production Package Recording Sheet
Appendix - 5 (8)
Appendix - 6 (8)
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10
09
08
07
06
05
04
03
02
01
10
09
08
07
06
05
04
03
02
01
link n.
LabCheckForm1.xls last update 13/09/2004
ID event
date
Sample ID
machine
PM P.O.
Red ink
Heat pattern
Red Ink
TS quality by dissolving
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Top Bottom Top Bottom Top Bottom Top Bottom check box check box check box check box check box check box check box check box
Conductivity
Package integrity
Checks
Type
LS P.O.
check box
LS (by red ink injection)
Type Check box legend
EX
E
Sara Davolio Monica Malagoli
PL
AM
X = not performed
KO = NOT passed
Temper.
Product Type
Operator signature
Pack Codes V = passed
ID event
Machine number
Machine type
Date
Laboratory Package Recording Sheet
C.2 Laboratory Package Recording Sheet
Appendix C:Data Record
C.2 Laboratory Package Recording Sheet
Appendix C:Data Record
C.3 Sample Collection Form
C.3 Sample Collection Form Sample Collection Sheet Machine Type Machine Number Operator Name
Date Time Batch No. Link No.
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EX
AM
PL
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E
TOP
BOTTOM Comments:
monica malagoli sara davolio
updated 13/09/2004
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Appendix - 7 (8)
Appendix C:Data Record
C.4 Troubleshooting General Data Form
C.4 Troubleshooting General Data Form Troubleshooting Sheet - General Data Test Code (if more than one) Date Report Reference
Package
Volume Family Opening
Filling Machine
Cutting Rail End Pieces Inductors Dollies Pulse Time TS Setting Jaw pressure (bar) Jaw Gap (mm) if not standard TS working window performed? TS working window settings and location
Purpose of the Test Package Integrity
Short description Amount of Samples Unsterility Rate Red Ink TS Cracks Inner bags heat Pattern
Numbering Progressive Project number
Notes
Appendix - 8 (8)
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Sealing Configuration
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PL AM
Filling product Production Date Exp.Date Product temperature (C) Packaging Material Design Packaging Material Converting factory P.Order LS Strip Al-Foil Thickness(µ)
EX
Customer
E
Type Development Step Serial number
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