Table of Contents1.About the Organization 7

1.1Units of Hetero Drugs 8

1.1.1 The Formulation Unit (Jeedimetla, Unit III) 9

2.What is a Formulation? 10

2.1 Preformulation 10

3.Dosage Forms 11

4.Tablet Manufacturing Process 13

4.1 Batch Manufacturing Record 13

4.2 Flow Diagram of Production Process 13

4.2.1. Granulation 14

4.2.1.1. What is an Active Ingredient? 14

4.2.1.2. What is an Excipient? 14

4.2.1.3. Stages in Granulation 15

4.2.2. Compression 19

4.2.3. Coating 21

4.2.4. Inspection23

5. Capsule 24

5.1 Capsule Shell type 24

5.1.1. Hard Shelled Capsules 24

5.1.2. Soft Shelled Capsules 25

5.2 Capsule Production 25

5.2.1. Granulation 25

5.2.2. Filling 26

5.2.2.1. Automatic Filling Machine 26

1

5.2.2.2. Capsule Sorter and Elevator27

5.2.2.3. Capsule Detection and Polishing 28

5.2.3. Sorting 29

5.2.3.1. Mini Capsule Sorter 29

5.2.3.2. Air Displacement Unit 29

5.2.4. Inspection 30

5.2.5. Packing 31

5.2.5.1. Blister Packing 32

5.2.5.2. Strip Packing 33

5.2.5.3. Container Packing 34

References 35

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1.About the Organization:

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 with definite advantages in terms of cost and 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 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 player in API(Active Pharmaceutical Ingredients) and finished dosages and its

manufacturing plants have approvals of USFDA (United States Food and Drug

Administration), WHO (World Health Organization) and cGMP (Current 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

companies which are part of the group are Hetero Labs, Hetero Research Foundation,

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 of their anti-HIV drugs which have huge markets are Nevilast-30, Nevilast-40,

Zidolam-N, etc.

They were awarded license to make generic Oseltamivir Tamiflu, by the Swiss firm

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

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

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 award (for the year 1999) against stiff competition from 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 compliance to the most stringent regulatory requirements, Hetero has today 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

compliance to the GMP requirements, Hetero has crossed numerous milestones 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)

4

1.1.1 The Formulation Unit (Jeedimetla , Unit III)

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. BLOCK A:

• Built up area of about 6510 sq.mt.

• Modular concept with unidirectional flow

• Spread in two floors

• Four modules /six packing lines

• Designed for solid dosage forms

• Approved by WHO, Geneva

ii. BLOCK B:

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.

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2. What is a Formulation?

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 a final medicinal product.

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:

Preformulation involves the characterization of a drug's physical, 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 to check whether there are any unwanted interactions between the

preparation and the container. If a plastic container is used, tests are carried out to see

whether any of the ingredients become adsorbed on to the plastic, and whether 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 products have been formed. 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

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dosage unit e.g. each tablet. The dosage should have a uniform appearance, with an

acceptable taste, tablet hardness, or capsule disintegration.

3. Dosage Forms:

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.

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. 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 & Metered dose inhaler

Solution for nebulizer

ii. Oral dosage forms:

Capsule

Powder

Solution

Suspension

Tablet

Buccal or sublingual tablet

Orally disintegrating tablet

Thin film

iii. Ophthalmic dosage forms:

7

A dosage form for 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 material which bio erodes in the environment

of the eye.

iv. Otic dosage forms:

Ear drop (solution or suspension)

v. Parenteral dosage forms:

Solution or suspension 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 - Combines oil (80%) and water (20%). Effective barrier against

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)

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Vaginal ring

Vaginal tablet

4. Tablet Manufacturing Process

4.1. Batch Manufacturing Record

Any production in the pharmaceutical industry is followed strictly and blindly

according to previously developed protocols. So for production, the entire process,

precautions, equipment, conditions to be maintained are mentioned in the Batch

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.

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Raw material

Granulation

Compression

Coating and inspection

Production begins once the raw materials enter the production unit. The entire

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 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.

4.2.1.2. What is an excipient?

An excipient is an inactive substance used as a carrier for the active ingredients of a

medication. In many cases, an "active" substance (such as 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

formulations with very potent active ingredients, to allow for convenient and 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, 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

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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.

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:

Firstly, the raw materials are sieved in a sifter. This will ensure that similar sized

particles are separated.

Then the API and excipients are pre-mixed for 10 minutes in a rapid mixer granulator.

Pre-mixing will lead to formation of uniform mixture

Then solvent such as water or 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 the lumps are processed in the Multimill. The required size granules 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.

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The machines required for the entire Granulation process are:

I.Rapid Mixer Granulator:

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.

12

II.Fluid Bed Dryer:

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

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.

13

IV.Multimill:

Inside this there are many cutting knives. They cut down the lumps to the granule size we

want.

V.Double cone blender:

It is used for mixing dry powder and granules homogeneously. Only two third of the

container is filled in this type of mixer to achieve proper mixing. If 100 tablets 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.

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4.2.2. Compression:

Before Compression, the blend which is stored in the blend store room is sent to the

quality control department for content uniformity testing. They check if each tablet contains

the mentioned amount of drug by assay. Once they give their approval, compression of

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 in the 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 and lower) are fixed onto a turret. When the powder is pressed in between the two

dies, it forms a tablet.

15

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.

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.

During the compression, once in half an hour, average weight, friability, 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:

16

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.

Tablet Deduster:

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 past, the process has many drawbacks. Modern tablet coatings are polymer and

polysaccharide based, with plasticizers 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. 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 dioxide can protect light-

sensitive 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

17

by taking a long time to reach the small intestine where they are absorbed. 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 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.

This is the last stage in tablet formulation and it is 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. Controlling site of drug release

2. Providing controlled, continuous release or reduce the frequency of drug dosing

3. Maintaining physical or chemical drug integrity

4. Enhancing product acceptance and appearance

Sugar coating is done by rolling the tablets in heavy 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. It also adds a substantial amount of weight to the tablet which

can create some problems in packaging and 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, or where the time of passage may compromise its effectiveness, in favor of

dissolution in the small intestine, where the active principle is better absorbed.

18

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:

19

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

convenient way for the consumers to take strong tasting vitamins and herbal 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:

They are also known as Hard Gelatin Capsules. They are made 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 in animal’s body.

Gelatin is obtained from collagen when it is heated. Hard gelatin capsules are primarily used

for filling of drugs in dry or powdered form.

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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) Granulation

2) Filling

3) Sorting

4) Inspection

5) Packing

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 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.

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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)

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).

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5.2.2.2 Sorter and Elevator (SE 100):

Sorter And Elevator machine sorts out the 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 machine through elevator. This eliminates stoppage of

the automatic capsule-filling machine, which could occur due to presence of defective

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 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

23

detected as not filled properly. Automatic Filling Machine has the capacity to fill 25000 in

one hour. After filling is completed capsules send to Detection and Polishing machine (DP

100).

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:

Capsules are sent to mini capsule sorter from DP 100. MCS100 is a specially

designed machine to sort out automatically capsules of loose caps and diametrically

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):

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.

25

Air Displacement Unit (ADU 100):

5.2.4. Inspection:

After sorting of capsules, they are sent for manual inspection. Capsules are inspected

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

machine tablet/capsule sorter. Using this manual inspection, we can sort out capsules which

are defective from the good capsules.

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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:

Blister packing

Strip packing

Container packing

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.

27

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.

Features:

Compact size with all function and fast production.

Compressed air forming creates equivalent blister pocket.

Continuous motion offers best filling condition.

Equipped with trouble detection system which displays where the trouble is.

The machine adopts a no waste trimming method to save material.

It is very easy to exchange all the size change parts. It takes less than 30 minutes to finish.

Main frame is covered with stainless steel. This makes it easier to clean and meets cGMP

Standard.

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It is neither noise nor creates public hazards and it is easy to operate.

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 it can also produce ALU-ALU. It uses cold extrusion, forming, feeding, sealing,

embossing, perforating, and finally trimming. This machine waste no materials because no

scraping between two blisters. This machine specially designed for the ALU/ALU

product for the purpose of better preservation. (Preventing air from getting into the blister

packs and preservation from exposure to light rays).

5.2.5.2Strip packing:

In Strip packing Tablets or Capsules are packed such that both sides having

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

product. It is easy to operate and anyone can learn the operation instantly. The mould/die can

be easily replaced within 40 minutes.

5.2.5.3. Container packing:

In container packing required number of capsules or tablets are filled in containers of

specified size. Before packing containers and cotton to be filled are tested by quality control

department.

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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

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