Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 1 of 11
Table Of Content
1.
Objective
2.
Scope
3.
Responsibility ( Client & Manufacturer )
4.
Machine Description
5.
Technical Specification
6.
Technical Specifications of the sub – components/ bought out items, and their make, model & quantity, and backup records/ brochures
7.
Details of Utilities
8.
Identification Identificati on of components for calibration
9.
Safety features and alarms
10.
FAT procedure
11.
Reference Documents
12.
GA Drawing
13.
Catalogue
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 2 of 11
1.0
Objective
To design, engineer, and supply the Rapid Mixer Granulator for Powder & Granules as per cGMP guide lines and to provide assurance that the machine is manufactured as per the users requirement it complies with Scope of Supply.
2.0
Scope
The scope of this qualification document is limited to the Preliminary Design Qualification of Rapid Mixer Granulator . This pre. qualification document is part of a ordering activity for the Rapid Mixer Granulator.
3.0
Responsibilities
Client
To provide the data sheet for the requirement.
To perform the Factory Acceptance Test (FAT).
Manufacturer
1.
To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
i.
Machine overview
ii.
P & ID drawing
iii.
Equipment orientation with layout
iv.
Specifications of the sub – components/ bought out items, and their make, model & quantity, and backup records/ brochures
v.
Details of utilities
vi.
Identification of components for calibration
vii.
Material of construction of all components
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 3 of 11
viii.
2.
Brief process description
ix.
Safety features and alarms
x.
Pre – installation requirements
To facilitate the client for the Factory acceptance test of the machine at their works/ site.
3.
To confirm the safe delivery of the equipment to the user site.
4.
To ensure that no un – authorized and / or unrecorded design modifications shall take place. It at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
5.
To ensure the proper installation and commissioning of the equipment.
4.0
Machine Description
This equipment is a agitator mixer, in which a bottom entry agitator performs the function of wet mixing, and a side mounted chopper blade breaks the lumps into granules. Discharge is side mounted.
5.0
Technical Specifications
Equipment
Rapid Mixer Granulator
Service
Wet Mixing and granulation
Volume
400 Litres Gross 320 litres Working
Capacity / Output 150 Kgs at 0.5 Kgs/ Liters bulk density of powder
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 4 of 11
MOC SNo
Item
Description / Specification
1
Contact Parts
SS316
2
Non Contact Exposed Parts
SS304.
3
Non Contact Internal Parts
Cladded
/
Covered
with
SS304. 4
Elastomers in contact with product
Silicon
5
Elastomers not in contact with product
Food Grade Neoprene.
Design Features SNo
Item
Description / Specification
1
Temperature
Ambient to 120 degrees ° C
2
Pressure
Atmospheric
3
Major Dimensions
As per our standards.
4
GA Drawing No.
B&A/GEN/RMG
5
Product Safety
All internal surfaces have smooth rounded edges.
Internal
surfaces
smooth
mirror
Polished. 6
Speed
Main agitator 60/120 dual speed approx Chopper dual speed 1400 & 2800 approx
7
Drive
Non Ex proof TEFC
8
Electricals
Non Ex proof TEFC
Operating Features SNo
Item
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Description / Specification
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
1
Page 5 of 11
Charging
Through the top of the bowl manually or by bin loading arrangement ( Optional ).
2
Discharge
Through
pneumatically
operated
side
discharge valve directly into Cone mill or FBD bowl. 3
Mobility
The machine is to be placed in one location.
4
Cleaning
To be cleaned manually or optionally a CIP system can be provided.
Documents to be provided
1.
As Built Drawings
2.
Material TC
3.
Motor TC
4.
Gear Box TC
5.
Operation / Instruction Manual
6.
Guarantee Certificate
General Description Of Machine
Bowl
The bowl consists of
Flat bottom
Central cylindrical shell
Inverted conical frustum at the top.
Flanged lid with counter weight for easy opening
Side mounted chopper assembly
Side mounted discharge.
Bottom entry main agitator.
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 6 of 11
Lid
The lid consists of
Flange matching the bowl flange.
Counter weight
View port & Small part addition inlet
Air vent with filter
Main Agitator
The main drive consists of
750/1440 rpm, 30 / 40 HP dual speed motor
Profiled machined blade
Teflon Seal to avoid powder entering the shaft
Belt drive between gear box and motor.
Chopper
Consists of
1440 & 2800 rpm, dual speed 4 / 5 HP motor
Specially designed blade
Teflon Seal to avoid powder entering the shaft
Directly mounted motor.
Discharge
Side mounted discharge valve, located on shell near bowl bottom.
Pneumatically operated.
Discharge hinged for opening and cleaning.
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 7 of 11
Height to suit FBD Bowl or comill with FBD Bowl.
Cleaning
The bowl is to be cleaned in place. Spray nozzles provided for bowl and discharge opening. Pump and piping is offered as an options.
Mounting
MS Rectangular stand supports the entire assembly of bowl, drive and platform. The stand is provided with SS304 covers on all side.
Controls
1.
Phase Indication Lamps ( In Main Panel)
2.
Rotary Main switch
3.
Voltmeter ( In Main Panel)
4.
Current display for each motor
5.
Timer for Cycle Time
6.
Auto manual operation
7.
Slow - Fast – Stop operation for both agitators
8.
Indications for lid open
9.
Discharge operation
10.
Pressure switch for no air no operation
11.
Process display
12.
Emergency Off Push button
13.
Contactors, relays, Mcbs,etc,.
Note :
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Prepared By Minu Pathak
Checked By S M Rabee
Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 8 of 11
For Exproof models, the main panel is to be mounted outside the FLP area, Only MMI and FLP operator panel is provided near the machine.
6.0 Technical Specification Of Components & Sub – Components Used / Bought Outs. Drive
Non Exproof , TEFC
Electricals
Operator panel in ExProof ( Main panel to be mounted outside FLP area, MMI is mounted on the machine )
7.0
Details Of Utilities
Utilities SNo
Utiity
Specification
Unit
Quantity
1
Power
3 Phase, 410
HP
45
Volts, 50 Hz., 2
Compressed
3 Kgs/cm
CFM
10
Kgs
NA
Air 3
Steam
3 Kgs/cm2
4
Space
mm * mm * mm
L * b * ht
Required
8.0
2000 * 2000 * 3500 ( tentative )
Identification Of Component For Calibration
1.
Voltmeter
2.
Ammeter
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Checked By S M Rabee
Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
9.0
Page 9 of 11
Safety Features
1.
Overload Relay for motor.
2.
All moving parts are provided with limit switches.
3.
All sharp edges removed.
4.
Lid and discharge provided with limit switches so that impellers and discharge do not operate with lids are opened.
10.0
5.
Chopper motor interlocked with main motor.
6.
Machine will not operate in case air pressure is low.
7.
Earth arrangement provided for machine.
Fat Procedure
Factory Acceptance Test Procedure shall be as follows: After the completion of erection work of the machine, client shall be informed to perform the factory acceptance test (FAT).
Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:
11.0
1.
Test Criteria
2.
Design Verification Check List
3.
Deficiency & Corrective Action report
4.
Pre – installation requirements
5.
Final report
Reference Documents
Manufactures Brochure (s)/ Manual (s). ( Title and Location ) to be supplied with the Installation qualification documents
Name Date Signature
Prepared By Minu Pathak
Checked By S M Rabee
Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 10 of 11
1. Instruction & Maintenance manual 2. Calibration certificates 3. Material of construction certificates 4. GA drawing
Bought Out
Brand
Motor
Hindustan
Gear Box
Shanti/CPEC
Electricals
Siemens / L&T
Push Buttons
Technic
Variator
Schneider, Telemechanic
PLC
Schneider, Telemechanic
Pneumatics
Festo / Dancal
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Client Document
Preliminary Design Qualifications
Equipment
Rapid Mixer Granulator 150 Kgs
Offer Ref. & Date Page
Page 11 of 11
CHOPPER MOTOR
COUNTER WEIGHT
DISCHARGE
ST AIRCASE
PLATFORM
OPERATING PANEL BOWL
CONTROL PANEL DRIVE ASSEMBLY
STAIRCASE AND PLATFORM DEPEND ON MACHINE HEIGHT MACHINE HEIGHT DEPENDS ON fbd BOWL HEIGHT
TITLE
RAPID MIXER GRANULATOR PRODUCTION MODELS
Designers and Manufacturers of Pharmaceutical Machineries
CLIENT B&A/GEN/RMG
Phone (9122) :23747768/69 (9122) 23782714 Fax
(9122) :23747768
Mobile: 98210 78933
DATE
27/06/05
SCALE
NTS
E-Mail :
[email protected]
Name Date Signature
Prepared By Minu Pathak
CHKD.
Checked By S M Rabee
SMR
