Table of Contents 1.Abo .Abou ut the the Organ rganiz iza ation tion 1.1Units of Hetero Drugs
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1.1.1 The Formulation Formulation Unit Unit (Jeedimetla, (Jeedimetla, Unit III) III) 9
2.What is is a Formulation ion? 2.1 Preformulation
3.Dosage Fo Forms
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4.Tablet Manufacturing Process13 4.1 Ba Batch Ma Manufacturing Re Record
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4.2 4.2 Flow Flow Dia Diagr gram am of of Prod Produc ucti tion on Proc Proces ess s 4.2.1. Granulation
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4.2.1.1. 4.2.1.1. What is an Active Active Ingre Ingredient dient? ? 14 4.2 4.2.1.2 .1.2.. Wh What is an Exci Excip pient? ent?
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4.2 4.2.1.3 .1.3.. Sta Stag ges in Gr Granu anulati ation
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4.2.2. Compression 4.2.3. Coating
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4.2.4. 4.2.4. Inspec Inspectio tion n 23
5. Capsule
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5.1 5.1 Cap Capsu sule le Shel Shelll typ type e 24 5.1.1. 5.1.1. Hard Shelled Shelled Capsul Capsules es 24 5.1.2. 5.1.2. Soft Soft Shell Shelled ed Capsul Capsules es 25 5.2 Capsule Capsule Productio Production n 25 5.2.1. Granulation 5.2.2. Filling
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5.2.2.1. Au Automati atic Fi Filling Ma Machine
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5.2. 5.2.2. 2.2. 2. Caps Capsul ule e Sort Sorter er and and Elev Elevat ator or
5.2. 5.2.2. 2.3. 3. Caps Capsul ule e Dete Detect ctio ion n and and Poli Polish shin ing g 5.2.3. So Sorting
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5.2.3.1. Mi Mini Capsule So Sorter
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5.2. 5.2.3. 3.2. 2. Air Air Disp Displa lace ceme ment nt Unit Unit
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5.2.4. Inspection 5.2.5. Pa Packing
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5.2.5.1. Blister Packing
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5.2.5.2. Strip Packing
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5.2.5.3. 5.2.5.3. Containe Containerr Packing Packing 34
References
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1.About the Organization: Cancel
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Hetero Drugs Limited is an Indian pharmaceutical company established in the year
1993, by Dr. B.Partha Saradhi Reddy, a PhD scientist and expertise in chemistry. It was started by him with a vision to be recognized as an aggressive company that combines its strength of R&D and manufacturing manufacturing with definite advantages in terms of cost and chemistry chemistry with a strong emphasis on quality of the products. The tag line of the company is “Where the future started yesterday ”.
Hetero is one of its kinds, of the very few companies companies which have been able to carve a niche in the pharmaceutical industry given the present scenario where it requires a right blend of intellectual strength, core competencies and a precise foresight for the future. Hetero has revenues over $500 million and employs over 5000 people. Hetero is a strong strong player in API(Ac API(Active tive Pharmac Pharmaceuti eutical cal Ingredient Ingredients) s)
and finished finished dosages dosages and its
manu manufa fact ctur urin ing g plan plants ts have have appr approv oval alss of USFDA (Uni (Unite ted d Stat States es Food Food and and Drug Drug Administration), WHO (Wor (World ld Heal Health th Orga Organi niza zati tion on))
and and cGMP
(Curr (Current ent Good Good
Manufacturing Practices). It has marketing presence in over 100 countries. Hetero drugs is the parent company in the Hetero group of companies and other compani companies es which which are part of the group are Hetero Labs, Hetero Hetero Researc Research h Foundat Foundation, ion, Symbed Labs limited, Cirex Laboratories, GenX Pharma and also foreign subsidiaries such as Invagen Inc, in US and Richmond labs in Argentina etc .Hetero also has its own retail chain of pharmacy outlets in India named as “Hetero Pharmacy”. It holds a leadership position in the manufacture of anti-retrovirals in Hyderabad. Some Some of their their anti-H anti-HIV IV drugs drugs whic which h have have hug hugee mark markets ets are Nevil Nevilast ast-30 -30,, Nevil Nevilast ast-40 -40,, Zidolam-N, etc. They were awarded license to make generic Oseltamivir Tamiflu, by the Swiss firm countries. Roche in 2005 .This generic is an anti-flu treatment for India and other developing countries. This drug is widely seen as the most promising treatment for combating any future pandemic of bird flu in humans. The company says that Hetero Drugs is among the first to demonstrate that it is technically capable of making a reliable generic version of tamiflu, this decision could make it easier and cheaper for poorer nations to acquire stocks of the drug. 3
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Also now in 2009, as the swine flu outbreak is spreading across the globe and various health organizations and government agencies are piling up stocks of Oseltamivir (tamiflu) as precautionary measure, hetero is helping many countries including India by supplying the Cancel Download And Print generic Oseltamivir under its brand name “Fluvir” Few of the milestones of the company are:
National Award for “Best Efforts in Research and Development” from the Department of Scientific and Industrial Research, Ministry of Science and Technology, Government of India, in the year 1996.
Highest Exporter Exporter award (for the year 1999) against stiff competition from internationally internationally recognized domestic competitors.
Approval of the API facilities by USFDA for compliance to CGMP norms.
Approval of the finished dosage facilities by WHO for the supply of anti-retroviral drugs.
1.1Units of Hetero Drugs With full-fledged marketing capabilities, the company has been able to market its products in over 100 countries in Asia, Middle-east, Eastern Europe and Latin America. With its complia compliance nce to the most stringent stringent regulat regulatory ory requirem requirements ents,, Hetero Hetero has today today gained gained foothold to market several of its APIs in the United States, Canada and Europe. With all six manufacturing facilities being supported by excellent infrastructure and comp compli lianc ancee to the the GMP GMP requi requirem rement ents, s, Hete Hetero ro has has cross crossed ed numero numerous us mile milesto stones nes in a comparatively short period since its inception. Among the six manufacturing units four are in Hyderabad, one is in Visakhapatnam, and the other is in Himachal Pradesh. In Hyderabad, the units are located as mentioned below: Unit
Location
1
Bonthapally(API)
2
Kazipally
3
Jeedimetla(Formulation)
4
Bonthapally(API)
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1.1.1
The Formulation Unit (Jeedimetla , Unit III) Cancel
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The unit in Jeedimetla is divided into two blocks namely block A and block B. It has been certified by ISO-9001:2000 for it maintaining clean and international standards in quality and manufacturing procedures. Installed production capacities of the facility on single shift basis per annum are as follows: Tablets
2.8 billion units
Capsules
250 million units
Liquid Orals
3.5 million units
The details of the blocks are as follows: i.
i.
BLOCK A:
•
Buil Builtt up up are areaa of abou aboutt 651 6510 0 sq. sq.mt mt..
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Modula Mod ularr conc concept ept with with unidi unidirec recti tiona onall flo flow w
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Spre pread in two floors ors
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Four Four modu module less /si /six x pac packi king ng line liness
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Desi Design gned ed for for sol solid id dosa dosage ge form formss
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Appr Approv oved ed by WHO, HO, Gene Geneva va BLOCK B:
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Built up area 16310 sq. mt.(GF+FF+SF)
•
Multi product concept
•
•
Designed for solid and liquid oral dosage forms Manufacturing facility confined to ground and second floor .
2. What is a Formulation? 5
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Formulation (also called as Pharmaceutical formulation), in pharmaceutics, is the process in which different chemical substances (called excipients), including the active drug (called API), are combined to produce medicinalAnd product. Cancel a final Download Print Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and studies have to be carried out to ensure that the drug is compatible with these other substances.
2.1Preformulation: Preform Preformulat ulation ion involves involves the charact characteriz erizatio ation n of a drug's drug's phy physica sical, l, chemical chemical,, and mechanical properties in order to choose what other ingredients should be used in the preparation. In dealing with protein pre-formulation, the important aspect is to understand the solution behaviour of a given protein under a variety of stress conditions such as freeze/thaw, temperature, shear stress among others to identify mechanisms of degradation and therefore its mitigation. It is also important important to check whether there are any unwanted interactions interactions between the preparation and the container. If a plastic container is used, tests are carried out to see whet whether her any any of the ingre ingredie dient ntss becom becomee adsorb adsorbed ed on to the plast plastic ic,, and and whet whether her any any plasticizers, lubricants, pigments, or stabilizers leach out of the plastic into the preparation. Even the adhesives for the container label need to be tested, to ensure they do not leach through the plastic container into the preparation. Stability studies are carried out to test whether temperature, humidity, oxidation, or photolysis (ultraviolet light or visible light) have any effect, and the preparation is analysed to see if any degradation degradation products have been formed. Formulation Formulation studies then consider such factors as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. The drug must be combined with inactive additives by a method which ensures that the quantity of drug present is consistent in each dosag dosagee unit unit e.g. e.g. each each table tablet. t. Th Thee dosag dosagee shoul should d have have a unifor uniform m appea appearan rance, ce, with with an acceptable taste, tablet hardness, or capsule disintegration.
3. Dosage Forms:
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A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. Cancel Download And Print Various dosage forms may exist for the same compound, since different medical
conditions may warrant different routes of administration. For example, persistent vomiting may make it difficult to use an oral dosage form; in this case, it may be advisable to use either an injection or a suppository suppository.. Also, specific dosage forms may be warranted for certain medications, since there may be problems with stability, e.g. insulin cannot be given orally since it is digested by the gut. Examples of the different types of dosage forms: i. Inhaled dosage forms:
Aerosol
Gas
Inhaler & Inhaler & Metered dose inhaler
Solution for nebulizer for nebulizer
ii. Oral dosage forms:
Capsule
Powder
Solution
Suspension
Tablet
Buccal or sublingual or sublingual tablet
Orally disintegrating tablet
Thin film
iii. Ophthalmic dosage forms:
A dosage form for ophthalmic ophthalmic drugs is disclosed. The dosage form is a suspension of 10 to 300 micrometer particles in a liquid medium. The particles are made up of drug enclosed within a drug release rate-controlling rate-controlling material which bio erodes in the environment environment of the eye.
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Print document iv. Otic dosage forms:
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Ear drop (solution or suspension)
v. Parenteral dosage forms:
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Solution or suspension for injection for injection
vi. Rectal dosage forms: Enema Suppository
vii. Topical dosage forms:
Cream - Emulsion of oil and water in approximately equal proportions. Penetrates stratum corneum outer layer of skin well.
Ointment - Comb Combine iness oil oil (80%) (80%) and and water water (20%) (20%).. Effe Effecti ctive ve barri barrier er agains againstt moisture loss.
Gel - Liquefies upon contact with the skin.
Paste - Combines three agents - oil, water, and powder; an ointment in which a powder is suspended.
Powder
Liniment
Lotion
Transdermal patch
viii. Vaginal dosage forms
Douche Intrauterine device Pessary (vaginal suppository)
Vaginal ring
Vaginal tablet
4. Tablet Manufacturing Process 4.1. Batch Manufacturing Record 8
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Any produc producti tion on in the pharm pharmac aceut eutica icall indus industr try y is follow followed ed stric strictl tly y and and blind blindly ly accor accordi ding ng to previ previous ously ly devel develope oped d proto protocol cols. s. So for produc producti tion, on, the the entir entiree proce process, ss, pre preca caut utio ions ns,, equi equipm pmen ent, t, cond condit itio ions ns to Download be main mainta tain ined edPrint are are ment mentio ione ned d in the the Batc Batch h Cancel And Manufacturing Record (BMR). This BMR is documented by the R&D unit and checked for improvements by the Analytical Development unit.
4.2. Flow Diagram of Production Process:
Firstly the raw material is obtained from the ware house unit. They calculate the exact amounts required for production of one batch of tablets and deliver accordingly into the production unit through the pass box. The raw material, before entering is tested by Quality Control and checked if it is suitable for production.
Produ Product ction ion begin beginss once once the the raw mater materia ials ls enter enter the produ product ction ion unit. unit. Th Thee entir entiree production procedure can be divided into five stages. They are:
Granulation
Compression
Coating
Inspection
Packing
4.2.1. Granulation: Granulation is the process of formation of grains. In simple terms it is the process of mixing of active ingredient with the excipients so that particles accumulate to reach a stage where there is uniformity and no voids in the material.
4.2.1.1 What is an Active Ingredient? An active ingredient (AI), also active pharmaceutical pharmaceutical ingredient (API) or bulk active is the substance in a drug that is pharmaceutically active.It is that component of the tablet which has a therapeutic action. The active ingredients are manufactured at bulk drug units also called API units.
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4.2.1.2. What is an excipient? first need to download it.
An excipient is an inactive substance used as a carrier for the active ingredients of a Download And Print medication. medication. In many many cases cases,, anCancel "acti "active" ve" subst su bstanc ancee (such (such as aspirin) aspirin) may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or mixed with an excipient. Excipients are also sometimes used to bulk up formulat formulations ions with with very potent active active ingredie ingredients, nts, to allow allow for conveni convenient ent and accurate accurate dosage. In addition to their use in the single-dosage quantity, excipients can be used in the manufacturing process to aid in the handling of the active substance concerned. Depending on the route of administration, administration, and form of medication, different excipients may be used. Often, once an active ingredient has been purified, it cannot stay in purified form for long. In many cases it will denature, fall out of solution, or stick to the sides of the container. To stabilize the active ingredient, excipients are added, ensuring that the active ingredient stays "active", and, just as importantly, stable for a sufficiently long period of time that the shelf-life of the product makes it competitive with other products. Thus, the formulation of excipients in many cases is considered a trade secret. secret. Types of excipients are:
Anti-adherants
Binders
Coaters
Disintegrants
Fillers
Flavours
Glidants
Colours
Lubricants
Preservatives
Sweeteners
4.2.1.3 Stages in Granulation: The Granulation is performed in the following stages: 10
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Firstly, the raw materials are sieved in a sifter. This will ensure that similar sized particles are separated.
Cancel Download Andminutes Print in a rapid mixer granulator. Then the API and excipients are pre-mixed for 10
Pre-mixing will lead to formation of uniform mixture
Then solvent such as water or isopropyl isopropyl alcohol are added. The solvent will be added continuously until the required size grains are obtained.
Then the granules are collected and dried under a FBD (Fluid Bed Dryer).
Then the dried granules are sieved in a sifter.
The lumps formed after solvent addition will be collected on the top of the sifter.
Then Th en the the lump lumpss are are proce processe ssed d in the the Mu Mult ltim imil ill. l. Th Thee requi required red size size granul granules es are collected.
Finally the granules are blended in a double cone blender by adding of lubricants
Then the blend is collected and stored in Blend Hold Room.
The machines required for the entire Granulation process are: I.Rapid Mixer Granulator:
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The applications of Rapid Mixer Granulator (RMG) are that the impeller (which is inclined) sets the entire mixture in a whirling-rising tumbling motion ensuring a quick and even distribution of all dry components which leads to an even wetting of every granule. Another advantage is that the vessel of the RMG is jacketed and steam can be passed to undertake mixing activities which require heating.
II.Fl II.Flui uid d Bed Dry D ryer er :
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The product to be dried is fluidized by passing hot air through it. The process achieves fast heat transfer making it very efficient, yet gentle on the product. This is controlled by PLC (Programmable Logic Control).We just need to adjust the temperature and time of drying. The time will be 10 mins for isopropyl alcohol and 30 mins for water. Its capacity is 50 kgs to around 5 tons. III.Sifter III.Sifter
A mesh of required size is placed and it works like a vibrating sieve. The particles of greater sizes will be collected in the top dish.
IV .Mul .M ulti timi mill ll :
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Inside this there are many cutting knives. They cut down the lumps to the granule size we want. V.Doubl V.Do ublee cone blende ble nderr:
It is used for mixing dry powder and granules homogeneously. Only two third of the conta contain iner er is fille filled d in this this type type of mixer mixer to achiev achievee prope properr mixi mixing. ng. If 100 tablets tablets are are manufactured, all of them have same amount of the drug. It is because of blending. In this stage even lubricants are added. They increase the flow properties of the blend when it is in compression.
4.2.2. Compression: 14
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Before Compression, the blend which is stored in the blend store room is sent to the quality control department department for content uniformity testing. They check if each tablet contains the mentioned amount of drug Cancel by assay. Once theyAnd givePrint their approval, compression of Download tablets start. The compression is done on a compression machine. There are two types of compression, Automatic and Semi-automatic. The automatic machine has 45 stations and is controlled by PLC, whereas whereas in the semi-automatic semi-automatic machine, there are 27 stations. Also the weight of tablet (depth of fill) and the thickness are to be adjusted manually.
The blend is added into the hoppers. It then flows into the die bore. The amount of blend is adjusted by the feed frame (bronze colored) based on our weight setting. The punches (upper (upper and lower) lower) are fixed onto a turret. turret. When the powder powder is pressed pressed in between between the two dies, it forms a tablet. The pressure of the rollers pressing the dies is set by the penetration wheel. Embossing on the tablets is done during compression .It is done by changing the punches to the ones which have impressions of the emboss.
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To get a particular hardness, thickness and weight many trials have to be performed. Then batch production starts. 27 station means in one rotation of the turret wheel, 27 tablets can be punched. Duri During ng the the comp compre ress ssio ion, n, once once in half half an hour hour,, aver averag agee weig weight ht,, fria friabi bili lity ty,, and and disintegration are checked. If any of these are abnormal, production is stopped for a while and checked. Friability is an important factor in tablet formulation to ensure that the tablet can stay
intact and withhold its form from any outside force of pressure:
Where Wo is the original weight of the tablets, and Wf is the final weight of the tablets after the collection is put through the friabilator. Friability below 0.8% is usually considered satisfactory. 16
Print document Tablet Deduster:
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The Tablet Deduster is used to dust off the powder of compression that might be present on the tablets. It is similar to polishing done in case of capsules.
4.2.3. Coating: Many tablets today are coated after being pressed. Although sugar-coating was popular in the the past, past, the the proce process ss has has many many drawb drawback acks. s. Mo Moder dern n tabl tablet et coati coatings ngs are polymer and polysaccharide based, with plasticizers with plasticizers and pigments and pigments included. Tablet coatings must be stable and strong enough to survive the handling of the tablet, must not make tablets stick together during the coating process, and must follow the fine contours of embossed characters or logos on tablets. Coatings can also facilitate printing on tablets, if required. required. Coatings are necessary for tablets that have an unpleasant taste, and a smoother finish makes large tablets easier to swallow. Tablet coatings are also useful to extend the shelf-life of components that are sensitive to moisture or oxidation. Opaque materials like titanium titanium dioxide can protect lightsensitive actives from photo degradation. Special coatings (for example with pearlescent effects) can enhance brand recognition. If the active ingredient of a tablet is sensitive to acid, or is irritant to the stomach lining, an enteric coating can be used, which is resistant to stomach acid and dissolves in the high pH of the intestines. Enteric coatings are also used for medicines that can be negatively affected affected by taking a long time to reach the small intestine where they are absorbed. Coatings Coatings are often chosen to control the rate of dissolution of the drug in the gastro-intestinal tract. Some drugs will be absorbed better at different points in the digestive system. If the highest percentage of absorption of a drug takes place in the stomach, a coating that dissolves quickly and easily in acid will be selected. If the rate of absorption is best in the large intestine or colon, then a coating that is acid resistant and dissolves slowly would be used to ensure it 17
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reached that point before dispersing. The area of the gastro-intestinal tract with the best absorption for any particular drug is usually determined by clinical trials. Cancel Download This is the last stage in tablet formulation and And it isPrint done to protect the tablet from
temperature and humidity constraints. It is also done to mask the taste, give it special characteristics, distinction to the product, and prevent inadvertent contact with the drug substance. The most common forms of tablet coating are sugar coating and film coating. Coating is also performed for the following reasons: 1. Contr Controll ollin ing g site site of drug drug rele release ase 2. Providing Providing controlled, controlled, continuous continuous release release or reduce the frequency frequency of drug dosing 3. Maintai Maintaining ning physi physical cal or chem chemical ical drug drug integr integrity ity 4. Enhancin Enhancing g product product accepta acceptance nce and and appear appearance ance Sugar coating Sugar coating is done by rolling the tablets in heavy syrup, syrup, in a similar process to candy making. It is done to give tablets an attractive appearance and to make pill-taking less unpleasant. However, the process is tedious and time-consuming and it requires the expertise of highly skilled technician. technician. It also adds a substantial amount of weight to the tablet which can create some problems in packaging and distribution. distribution. In comparison to sugar coating, film coating is more durable, less bulky, and less time consuming. But it creates more difficulty in hiding tablet appearance. One application of film-coating is for enteric protection, termed enteric coating. The purpose of enteric coating is to prevent dissolution of the tablet in the stomach, where the stomach acid may degrade the active ingredient, ingredient, or where the time of passage may compromise its effectiveness, effectiveness, in favor of dissolution in the small intestine, intestine, where the active principle is better absorbed.
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The Neocota apparatus is used to coat tablets. In this apparatus, there are 5 spraying guns. There is a solution tank. Firstly, spraying solution is prepared .It is then transferred to the solution tank and sprayed by the peristaltic pump. There is a facility to pass steam. This enables the drying of the coat on the tablets.
4.2.4. Inspection:
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In Inspection, the tablets are checked for any damages or deviations from the productions. There is a conveyor belt on which tablets will be flowing. The people inspecting would check for any dark spots, breakage etc. and would reject them. They are also passed through metal detectors, which would check if any metals have entered the tablets from the machine walls. Then the finished dosage is sent again for testing to the Quality Control Unit. 5. Capsule:
Capsules are one of the preferred dosage forms in the world today. Capsules provide a convenie convenient nt way for the consumers consumers to take strong tasting tasting vitamins vitamins and herbal herbal powders, powders, because of its neutral taste. Capsules gained popularity with their attractive appearance, ease of swallowing and their ability to be filled and processed easily. Capsules have advantage over tablets in the way they do not need fillers and binders in their production as tablets needed.
5.1 Capsule Shell Types: Capsule shells are of two types:
5.1.1Hard Shelled Capsules: 20
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They Th ey are also kno known wn as Hard Hard Gela Gelati tin n Capsu Capsules les.. Th They ey are are made made from from 86% of Bovine/Pigs skin and 24% of purified water. Gelatin contains water soluble proteins, which are primarily derived from the connective tissue collagen animal’s body. Cancel Download AndinPrint Gelatin Gelatin is obtained from collagen when it is heated. Hard gelatin capsules are primarily used for filling of drugs in dry or powdered form.
5.1.2Soft Shelled Capsules: They are primarily used for filling in liquids or oils in which Active Pharmaceutical Ingredient is either dissolved or suspended. They are made of 92% of methyl cellulose and 8% of purified water. These are also known as vegetable capsules.
5.2 Capsule Production: Capsule production contains five stages: 1) Gran Granul ulat atio ion n 2) Filling 21
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4) Insp Inspec ecttion 5) Packing
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5.2.1. Granulation: The steps that take place in granulation are as follows: •
The powder to be filled in the capsules is granulated to increase flow properties as is done in the tablet production before compression of powder in to tablets.
•
To explain briefly in the first step of granulation API and Excipients are in the Rapid Mixer Granulator (RMG 400) and mixed till granules are formed.
•
Then the mixture is transferred to Fluid Bed Drier for drying of mixture.
•
Then the powder is sieved in Sifter and undesired undesired granules are reduced in diameter using Oscillator Granulator like multimill.
•
The above two steps are continued till we get desired size granules.
•
Then the powder is blended in Double Cone Blender.
5.2.2. Filling: After blending in the granulation room the blender is taken to filling where the blended powder was filled in the capsules. Filling process is done using Automatic Filling Machine (AF 25T)
5.2.2.1. Automatic Filling Machine (AF 25T)
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Automatic filling machine has two hoppers in which powder to be filled in the capsules is loaded in one of the hoppers and capsules were loaded in another hopper using Sorter And Elevator machine (SE 100).
5.2.2.2 Sorter and Elevator (SE 100):
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Sorter And Elevator machine sorts out the diametrically diametrically defective capsules and sends only capsules of correct size in to the capsule filling machine(AF 25T).SE 100 feeds capsules of correct size in to the capsule filling filling machine through elevator. elevator. This eliminates eliminates stoppage of the automa automatic tic capsulecapsule-fil filling ling machine machine,, which which could could occur occur due to presence presence of defecti defective ve capsules in the loading station. The capsule sorter-cum-elevator is connected to the automatic capsule-filling machine's capsule hopper. In Automatic Capsule Filling Machine (AF 25T), it takes four capsules at a time. It then opens each capsule using vacuum fills each capsule with the pre- determined determined amount of drug and recloses it. Machine has logging pins using which it takes of the capsules for which top and body are not separated. After reclosing of capsules, capsules are tested with a sensor which checks whether the capsule is filled with pre-determined amount of drug. And AF 25T stops if a capsule is detected as not filled properly. Automatic Filling Machine has the capacity to fill 25000 in
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one hour. After filling is completed capsules send to Detection and Polishing machine (DP 100). Cancel
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5.2.2.3. Detection and Polishing Machine (DP 100):
Detection and polishing machine is an advanced DE-Duster and polishing machine. In this machine, it takes every capsule checks whether it has any loose powder over its surface and if it detects any, it polishes it and sends out. Capsules collected after polishing are sent to a sorting machine
5.2.3. Sorting: Capsu Capsule less are are sent sent to mini mini capsu capsule le sorte sorterr from from DP 100 100.. MCS10 MCS100 0 is a speci special ally ly desig designed ned machi machine ne to sort sort out autom automat atica icall lly y capsul capsules es of loose loose caps caps and diame diametr trica icall lly y defective. Thus MCS 100 ensures that only capsules of correct size and which are fitted exactly are sent out. Now capsules collected are perfectly filled and closed.
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5.2.3.1. Mini Capsule Sorter ( MCS 100): Cancel
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5.2.3.2. Air Displacement Unit (ADU 100): Air displacement unit is a dust extraction unit which was connected to the polishing chamber of Detection and polishing machine (DP 100).It is used to take out the loose powder collected in the polishing chamber of detection and polishing machine. Air Displacement Unit is also used for cleaning purpose in the Automatic Filling Machine.
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Air Displace Dis placement ment Unit Un it (ADU 100) 100 ):
5.2.4. Inspection: After sorting of capsules, they are sent for manual inspection. inspection. Capsules are inspected manually manually for any spots or scratches formed over the capsules. Capsules are dropped from the hopper on to a belt which moves continuously. This manual inspection was done using
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machine machine tablet/capsule tablet/capsule sorter. Using this manual inspection, inspection, we can sort out capsules which are defective from the good capsules. Cancel
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Capsule/Tablet Sorter
After capsules are inspected manually they passed through a metal detector. This detects any traces of metal and discards capsules having metal content in them. There by reducing the harmful effects of metals in capsules. Then capsules are sent to packing process.
5.2.5. Packing: Packing is of three types: 28
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Blister packing
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Strip packing
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Container packing
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5.2.5.1. Blister packing: In blister packing tablets and capsules are packed such that one side has Aluminium foil and another side having PVC transparent. On the aluminium foil required information such as composition, manufacturer and expiry date are printed already.
This KDB-120 is an automatic blister packing machine that fully automatically heating the PVC then forming, feeding, sealing, embossing, perforating & trimming. It can be used for the pharmaceutical packing (tablets, capsules, pills, and etc...), food and other similar products packing. This machine waste no materials because no scrap in between two blisters.
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Compact size with all function and fast production. Cancel Download And Print Compressed air forming creates equivalent blister pocket.
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Continuous motion offers best filling condition.
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Equipped with trouble detection system which displays where the trouble is.
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The machine adopts a no waste trimming method to save material.
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It is very easy to exchange all the size change parts. It takes less than 30 minutes to finish.
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Main frame is covered with stainless steel. This makes it easier to clean and meets cGMP
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Standard. •
It is neither noise nor creates public hazards and it is easy to operate.
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The expiration is about 4 times longer than traditional dot-type sealing.
KBD 120ALU
This KDB-120 ALU production procedure is the same as KDB-120 (PVC-ALU type) and and it can can also also produ produce ce ALUALU-AL ALU. U. It uses uses cold cold extrus extrusio ion, n, form forming ing,, feedi feeding, ng, seali sealing, ng, embossing, perforating, and finally trimming. This machine waste no materials because no scraping between two blisters. This machine specially designed for the ALU/ALU 30
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product for the purpose purpose of better preservation. preservation. (Preventing (Preventing air from getting into the blister blister packs and preservation from exposure to light rays). Cancel
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5.2.5.2Strip packing: In Stri Strip p pack packin ing g Tabl Tablet etss or Caps Capsul ules es are are pack packed ed such such that that both both side sidess havi having ng Aluminium foil and required information is printed on one of the sides. The KDS-800 is a high speed strip packing Machine and has been designed to pack capsules, Tablets or similar products. The basic simplicity operation offer wide range product and high quality strip sealing
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. Automatic feeding, sealing, slitting and cutting are done simultaneously. Therefore,
its efficiency is high, meaning production cost is decreased due to reduction of labour cost. The exterior of the machine is made of stainless steel which makes it easy to be cleaned and meet cGMP. Compact and constructed simply, the machine can and its be maintained easily, operates with low noise downtime is low. When packing operation is completed, the product shall be absolutely sealed and beautifully looked at. This certainly promotes the quality of the
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product. It is easy to operate and anyone can learn the operation instantly. The mould/die can be easily replaced within 40 minutes. Cancel
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5.2.5.3. Container packing: In container packing required number of capsules or tablets tablets are filled in containers of specified specified size. Before packing containers and cotton to be filled are tested by quality control control department.
References: Internet: 1. http://www.google.com 2. http://www.wikipedia.org 3. http://www.heterodrugs.com 4. http://www.pharmainfo.net 5. http://www.niroinc.com/pharma_systems/ 6. http://www.pamusallc.com 7. http://www.viable-herbals.com 8. http://www.samsmachines.com
Documents: The Batch Manufacturing Records (BMR’s) that were used in the manufacturing of tablets like ATOMAX-30 and ZIDO-H 100 32
