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ARISTOPHARMA is a leading Pharmaceutical company since 1990. ARISTOPHARMA achieved ISO-9001:2000 certificate in 2005. ARISTOPHARMA is committed to ensure better life through quality medicine.



Dhaka, Bangladesh.

Our training program had been scheduled 1st september to 7th October, 2009.

Solid Department

General Introduction

Solid dosage forms are some of the least expensive, most popular and convenient methods for drug delivery. They can be produced in a non-sterile environment and the technology is well-known after more than 100 years of development. Since most pharmaceuticals are produced in solid dosage forms, it is important that the unit operations for their production be thoroughly understood. This course focuses on the fundamentals of each discrete processing step (unit operation) required for the manufacture and packaging of tablets and capsules, the most common of solid dosage forms.

Total Units in Solid Department

Manufacturing area Packaging area

Granulation unit Compression unit Coating unit Capsule filling unit

Tablet Manufacturing

1. Introduction of Tablet
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients include binders, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to ensure that the tablet breaks up in the digestive tract; sweeteners or flavours to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A polymer coating is usually applied to hide the taste of the tablet’s components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life.

A typical tablet contains:


Filler or diluent A filler, such as sucrose,lactose,mannitol and dextrose is included to increase the size of the tablet. This is necessary as often the amount of ‘active’ is so tiny that the tablet would be too small to handle without it.
Disintegrant: Disintegrants help the tablet to break down into small fragments, when it is ingested. This helps the medicine to dissolve and be taken up by the body so that it can act more quickly. Disintegrants may include potato or cocoa butter.
Binder: A binder, such as glucose or sucrose, is added to hold the tablet together after it has been compressed, stopping it from breaking down into its separate ingredients.
Glidant: The glidant helps to keep the powder making up the tablet flowing as the tablet is being made, stopping it from forming lumps.
Lubricant: Lubricants ensure that the tablet has a smooth surface and that the powder does not stick to the equipment used to make the tablet.
Antiadherent: The antiadherent also stops the powder from sticking to the equipment as the tablet is being made.
Flavour: Flavouring agents help to make the tablet taste better.
Colourant: Colours are added to help you to recognize your tablet and to make it easier to take your medicine correctly.

Tablets are usually right, circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be beveled. They may have break-marks and may bear a symbol or other markings. Tablets may be coated.

1.4.Several categories of tablets for oral use may be distinguished:

· uncoated tablets;

· coated tablets;

· effervescent tablets;

· soluble tablets;

· dispersible tablets;

· orodispersible tablets;

· gastro-resistant tablets;

· modified-release tablets;

· Tablets for use in the mouth.

2.Production of tablet

In tablet production there are several steps involved which are following:

  • Dispensing and Granulation.
  • Blending
  • Powder compression
  • Coating
  • Blistering.
  • Secondary Packaging.



Granulation may be defined as a size enlargement process which converts small particles into physically stronger and larger agglomerates in order to facilitate compression for the production of tablet. All the materials are received from the dispensing unit and granulation is performed. For suitable granulation, it is required to have 30-40% powder and 60-70% granules and also 1-5% moisture in compressing particles.

Purposes of granulation

-To produce tablets of appropriate size.

– To prevent segregation of the constituents in the powder mix.

-To improve the flow properties of the powder mix.

-To improve compression nature of powder.

Types of granules

Two types of granules are produced in the four-granulation units of the industry, which include;

· Granules with active ingredient/s

· Placebo granules without any active ingredient/s for moisture sensitive active/s or drug/s

Granulation Processes which are performed in the Aristopharma plant are following:

· Wet Granulation.

· Dry Granulation.

· Direct compression

Wet granulation:

Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The amount of liquid can be properly managed, and over wetting will cause the granules to be too hard and under wetting will cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than solvents.

Dry granulation

This process is used when the product needed to be granulated may be sensitive to moisture and heat. Dry granulation can be conducted on a press using slugging tooling or on a roller compactor commonly referred to as a chilsonator. Dry granulation equipment offers a wide range of pressure and roll types to attain proper densification. However, the process may require repeated compaction steps to attain the proper granule end point.

Direct compression

This method is used when a group of ingredients can be blended and placed in a tablet press to make a tablet without any of the ingredients having to be changed. This is not very common because many tablets have active pharmaceutical ingredients which will not allow for direct compression due to their concentration or the excipients used in formulation are not conducive to direct compression.


Wet granulation Dry granulation
Weighing of active ingredient as well as excipients


Dry mixing


Wet mixing (in case of wet granulation) by addition of de-mineralized (DM) water or Maize starch paste in Rapid Mixer Granulator (RMG) for a certain time period specified in the Batch Production Record (BPR)


Initial Phase drying in Fluid Bed Dryer (FBD)


Milling in the Multimill


Partial drying in FBD


Milling in the Multimill


Terminal/Final drying in the FBD


Sieving in the Vibratory Sifter according to the required particle/granule size


Measurement of Loss on Drying (LOD)


Granules of desired size ready for blending.

Weighing of drugs and excipients


Dry mixing of drugs and diluents


Slugging or pre-compression


Milling and sieving




Discharge for compression

Ø Condition for manufacturing of Granules:

§ Relative Humidity: Not more than 55%.

§ Temperature: Below 250C.

Mixing & Blending

A powder blend should be as uniform as possible to assure the proper amount of medication in each dosages unit. The blending of solid particles is affected by the shape, density, size and size range of the particles, and surface effects such as absorbed liquid film, electrostatic charges and Van der Waals forces. Small particles are difficult to blend because they exhibit poor fluidity. However, more important than actual particle size is particle size range. All drugs and chemicals should be reduced to approximately the same size prior to weighing and mixing.


Tablet Processing unit: 1

Name of the machines Purpose
1.Planetary mixer-60 kg,

Gansons, India.

To mix the active ingredient and binder to form granules.
2.FBD-1-10 kg, Alliance Eng. Co. India To Dry granules.
3.Multi mill-1 To reduce the size of granules.
4.Double cone Blender To mix uniformly all the excipients.
5.Tablet oscillating Granulator To reduce the size of granules.
6.Paste Kettle Preparation of slurry
Name of the machines Purpose
1.RMG– 160 kg, Saral ENG. Company LTD. To mix the active ingredient and binder to form granules.
To Dry granules.
2.Y- cone and Double cone blenders. To mix the processed granules with lubricating agents.

Tablet Processing unit: 2

Rapid mixing granulator(RMG) Fluid bed dryer
multi milleer Double cone blender

Features Specifications: Rapid Mixer Granulator

Rapid Mixer Granulator has been specially designed to meet the special needs of tablet manufacturing industry. The machines we offer are in compliance with GMP standards and are known to deliver long time performance. The seal housing and drive shaft is flushed with cleaning water, which is then drained away from the machine, through built in drain tubes.

Technical Specifications :

  • Standard Processing Duration
  • Dry Mixing approx 3 – 5 Minutes
  • Wet Mixing approx 5 – 10 minutes
  • Wet Granulation approx 5 – 10 minutes
  • Discharge approx 1-15 minutes

Unique features :

  • RMG Improved Processing
  • Uniform distribution of all formulation ingredients
  • Reduced mixing and granulation time
  • Useful working capacity of up to 80% to 40% of bowl volume
  • Uniform granules by gentle processing
  • Widely applicable
  • Easy scale up & Scale down between machine sizes
  • Bowl shape design to have no dead spaces
  • Homogeneous binder distribution
  • Enclosed moving parts
  • Ensured safety
  • Air purge sealing for main shaft and Chopper shaft.
  • Auto / Manual Controls
  • Hydraulic/ Pneumatic lifting of main shaft for cleaning

Tablet compression

Compression of powder means reduction in bulk volume of a material as a result of displacement of the gaseous phase. Compression is used for the manufacturing of tablet.

In the compression of active pharmaceutical ingredients, overall control is essential to ensure high quality. Haphazard operations cannot be permitted in the compaction of substances that may be used to save life or to restore or promote health.

Adherence to the practices, complementing the various control tests carried out from the beginning at dispensing to the end of the production cycle with compaction, will contribute substantially to the production of consistently uniform batches of high-quality active pharmaceutical ingredient


General Compression Direct Compression
Granules (previously made)


Transfer of granules in the Hooper of tablet press machine

by hand or auto powder/granules loader


Rising of upper punch & dropping of lower punch


Filling of die cavity through feed frame


Removal of extra granules by scrape off plate


Coming down of upper punch for


compression to produce tablet


Raising of both upper & lower punches

to certain extent


Ejection of tablet with the help of take out plate


Conventional Uncoated Tablets

of desired shape and size

Milling & Screening of active ingredient/s

& the excipients


Mixing of the active ingredient/s

along with excipients including lubricants & disintegrants


Transfer of mixer in the hopper of tablet press machine

by hand or auto powder loader


Rising of upper punch & dropping of lower punch


Filling of die cavity through feed frame


Removal of extra granules by scrape off plate


Coming down of upper punch for

compression to produce tablet


Raising of both upper & lower punches

to certain extent


Ejection of tablet with the help of take out plate


Conventional Uncoated Tablets

of desired shape and size

Tablet-machine parts:

Ø Hopper

Ø Main compression roller

Ø Feed frame

Ø Compression station

Ø Feed paddles

Ø Ejection cam

Ø Draw down cam

Ø Take off blade

Ø Weight controller fills station

Ø Ejection station

Ø Pre-compression roller

Ø Take off chute.

Machines used in the Tablet Press unit for Compression:

# B-tooling machine ? Die 30 mm & punch 19 mm (35 punches)

# D-tooling machine ? Die 38 mm & punch 25 mm (27,35 punches)

There are 08 compression machines:

# 1 automatic machine 30 station. (Sejong)

# Press machines {Station: -16, 23(1), 27(1),35(3),37(1)}

Automatic tablet compression machine

1. New Se Jong Model 37 Station Rotary Tablet Press. Machine

(1) Unit has the capacity to deliver 54,000 to 216,000 tablets per hour. Maximum Tablet Diameter: 16mm, Maximum Tablet Thickness: 8.5 mm, Filling Depth: 4.5 to 10mm, 8.5 to 14mm, 12.5 to 18mm, Upper Punch Insert: 1 – 6mm, Maximum Pre-Pressure: 2 tons, Maximum Main Pressure: 8 tons, Die Size: 30.162 x 22.225mm.

(2) This is a high speed rotary tablet press, which is constructed of steel channel and aluminum bar, with exterior cover constructed of 304 Stainless Steel. Door is constructed of clear acrylic plate with cylinder supporter, Turret: FCD55. All contact parts are Stainless Steel. Machine Dimensions: 44” wide x 54” deep x 76” high, (without hopper), 82” high with hopper.

(3) Driving System: 5 HP motor, 1/19 ½ Speed Reducer, Rotation Speed of Turret: 25 – 75 RPM, Variable Speed Pulley (SAKAI) or AC frequency variation speed controller (Inverter), Clutch and Brake System.

(4) Turntable: Pitch Circle Diameter: 420 mm, 30 die holes, 30 holes each for upper and lower punches, Pre-compression roller, adjustable by index handle, Main compression roller, adjustable by index handle.:

(5) Lubrication System :Automatic lubrication by cycle pump, Lubricating interval and amount can be reset, Pump Motor: 0.9 Kw.

(6) Compression Force Buffering System: Hydraulic Cylinder buffers on both of Pre-compression and Main compression stations, powered by hydraulic pump, adjustable by a push button controller on the panel, Pump Motor: 0.2 Kw.

(7) Feeding System: Mechanical feeder as standard, open feeder is available as an option, Stainless Steel hopper with sight port.

(8) Tooling: IPT ‘B’ Type.

(9) Electric Control System: Index Handles, Hydraulic Pressure Indicator, Voltmeter, Ampere Meter, Digital Tachometer, Digital Product Counter, On – Off Switches, Function Selectors, Safety Lamps, Hydraulic Power Adjusting Buttons, Emergency Stop Button, Jog Drive Button, Alarm Buzzer. Comes with all controls and standard features needed to operate properly including a tool box and manual. If required, installation and training are available for an additional cost. The MRC 36 Tablet Press will come with standard instruction manual, installation qualifications and operation qualifications (IQOQ). Comes with a 1 year warranty. Delivery time: approximately 8 – 10 weeks from receipt of order and a 60% dep

Semi Automatic Rotary Tableting Press GMP

Common Problems that arise during Compression:

Common Problems that generally arise during compression are-

· Capping

· Chipping

· Sticking

· Weight variation

· Mottling

· Hardness problem

· Lamination

TABLET Coating

Coated tablets are tablets covered with one or more layers of mixtures of various substances such as natural or synthetic resins, gums, gelatin, inactive and insoluble fillers, sugars, plasticizers, polyols, waxes, coloring matter authorized by the competent authority and sometimes flavoring substances and active substances. The substances used as coatings are usually applied as a solution or suspension in conditions in which evaporation of the vehicle occurs. When the coating is a very thin polymeric coating, the tablets are known as film-coated tablets.

Coated tablets have a smooth surface which is often colored and may be polished;a broken section, when examined under a lens, shows a core surrounded by one or more continuous layers with a different texture.

Classification of Coating:

Mainly three types of coating are performed in the solid section. They are as follows:

Sugar coating Film coating Enteric coating
Aqueous coating Organic coating

1. Sugar Coating:-

In suitable sugar- coating equipment, the tablet cores are successively treated with aqueous sucrose solutions which, depending on the stage of the coating reached, may contain other functional ingredients e.g. fillers, colors etc. The build up of coating material is due to transference of coating medium from one tablet to another. Typically a single liquid application will be made which will be allowed to spread over the entire tablet bed utilizing the mixing capability of the particular equipment. At this point, drying, usually in the form of heated air will be used t o dry the application. The whole cycle will then be successively repeated.

Stages Of Sugar Coating-

  1. Sealing
  2. Sub­-coating
  1. Film coating:

In film coating two polymers are highly used. One is HPMC and another is Eudragit-L100 and L-50 (liquid). In aqueous solution water is used as solvent but in organic solution – methanol, methylene chloride and PEG 6000 are used. The distance between spray gun and tablet bed, incase of organic solvent is 3-4 inch and incase of aqueous solvents is 8 inch. Pan rotation is within 3-15/hr. it varies from product to product. Air pressure is maintained to 1.5-4 kg.

Steam temperature:

Coating Inlet Outlet
Organic 750c 650c
Aqueous 60/650c 50/550c

? 200 kg coating machine containing spray guns.

? 110 kg coating machine containing spray guns

? 100,70, 20 kg coating machine containing spray guns

3.Enteric coating:

There are two steps for enteric coating

? Sub-coating: Sub coating is performed by using HPMC as polymer with either organic or aqueous solution. This process performs for 5 hours.

? Enteric coating: Enteric coating is performed by using eudragit L-100 or L-50 over the sub coating. This is done for 15 hours.

Machines used for both Film & Enteric Coating:

Name of the Machine CAPACITY

FIGURE: Sugar coating and Film coating machines.

q Condition required during Coating:

Relative Humidity: Not more than 50%.

Temperature: Below 250C.

Common problems associated with tablet coating:

  1. Logo bridging


Ø Surface characteristics of the product being coated

Ø Inadequate adhesion of film coating

Ø Inadequate design of logo (e.g. too detail/fine logo)


Ø Modify core formulation to include more hydrophilic ingredients

Ø Increase core porosity

Ø 0Using formulation with increased adhesion property.

Ø Increase area within the debossing and modified angles.

2. Core erosion


Ø Inherent softness or high friability of core.

Ø Excessive pan speed in coating process.

Ø Spray rate too low.

Ø High sensitivity of core to moisture as coating is applied.


Ø Increase mechanical strength of core.

Ø Decrease pan speed.

Ø Increase spray rate.

3. Edge chipping/erosion


Ø Low mechanical strength of coating

Ø Excessive pan speed

Ø Low solid content in coating liquid

Ø Low spray rate

Ø Sharp edges on tablets

Ø Worn tablet punches


Ø Using formulation with increased mechanical strength

Ø Decreased pan speed

Ø Increase solid content in coating liquid

Ø Decrease spray rate

Ø Use modified punch design

4. Picking/sticking:


Ø Spray rate too high

Ø Inadequate drying condition

Ø Pan speed too low

Ø Inadequate atomization of coating liquid

Ø Poor distribution of coating liquid


Ø Decrease spray rate

Ø Increase drying condition

Ø Increase pan speed

Ø Increase atomizing air pressure/volume

Ø Increase number of spray gun

5. Cracking:


Ø Low mechanical strength of coating, exacerbated by inadequate plasticization, excessive pigmentation.

Ø Core has significantly different thermal expansion characteristics than coating.

Ø Extended strain relaxation of core after compaction.


Ø Selecting formulation with increased mechanical strength and elasticity properties.

Ø Avoid use of mineral type fillers (e.g. CaCO3, CaSO4, MgCO3 etc.)

Ø Extend holding period of tablets prior to submitting them to coating process.

6. Peeling


Ø Low mechanical strength of coating

Ø Poor adhesion of coating to tablet surface


Ø Using ingredients of improved mechanical strength.

Ø Using ingredients with improved adhesion properties.

7. Orange peel/roughness


Ø Viscosity of coating liquid is too high

Ø Poor atomization of coating liquid

Ø Excessive drying condition

Ø Over wetting (causing coating too rub)


Ø Decrease solid content of coating liquid

Ø Increase atomizing air pressure/volume

Ø Decrease inlet air temperature/flow rate

Ø Decrease spray rate

8. Twinning


Ø Spray rate too high

Ø Pan speed too low

Ø Inappropriate tablet shape


Ø Decrease spray rate

Ø Increase atomizing efficiency

Ø Increase pan speed

Ø Select new tablet shape that decrease chances of flat surfaces coming into contact during application of coating liquid. (e.g. avoid capsule shape tablet with thick side wall)

9. Tablet-to-tablet color variation


Ø Too little coating applied

Ø Inadequate mixing of tablet during coating

Ø Poor opacity (or hiding power)

Ø Solid content of coating liquid too high

Ø Insufficient number of spray gun


Ø Increase quantity of coating applied

Ø Increase pan speed/increase improve baffle system

Ø Reformulate coating with respect to colored ingredients or use an opacified white pre-coat.

Ø Decrease solid contents of coating liquid.

Ø Increase number of spray gun.

Number of tablet being produced in ARISTOPHARMA.

Capsule preparation

Trade name Generic name Strength
A-MYCIN Erythromycin 250mg, 500mg
ARISTO GOLD Multivitamin (A-Z)
CALBON D Calcium+Vitamin D3 500mg+200IU
ALFA-E Vitamin E 200mg
XPA Paracetamol 500mg
GLUCOMET Metformi 500mg, 850mg

2. Capsule


Capsules are solid preparations with hard or soft shells of various shapes and capacities, usually containing a single dose of active substance(s). They are intended for oral administration.

The capsule shells are made of gelatin or other substances, the consistency of which may be adjusted by the addition of substances such as glycerol or sorbitol. Excipients such as surface-active agents, opaque fillers, antimicrobial preservatives, sweeteners, colouring matter authorised by the competent authority and flavouring substances may be added. The capsules may bear surface markings.

The contents of capsules may be solid, liquid or of a paste-like consistency. They consist of one or more active substances with or without excipients such as solvents, diluents, lubricants and disintegrating agents. The contents do not cause deterioration of the shell. The shell, however, is attacked by the digestive fluids and the contents are released.

Several categories of capsules may be distinguished:

  • hard capsules;
  • soft capsules;
  • gastro-resistant capsules;
  • modified-release capsules;
  • cachets.

In this pharmaceutical industry filling (encapsulation), sealing and polishing (if required) of capsules of hard gelatin shell are done during manufacturing, as the industry does not manufacture any capsule shell.

The active is filled in the empty the hard gelatin capsule shell in the form of-

Ø Powder

Ø Pellets

There are 6 different sizes of empty hard gelatin capsule shells used in Aristopharma Ltd. for general production, which include

§ Capsule shell size 0

§ Capsule shell size 00

§ Capsule shell size 1

§ Capsule shell size 2


§ Capsule shell size 3

§ Capsule shell size 4

# Encapsulation Process by Automatic Capsule Filling Machine:

For encapsulation of pellets the following procedure is done with the help of Automatic Capsule Filling Machinein the capsule filling units of Aristo Pharma Ltd.;

Blend Pellets with NPS




For encapsulation of powder,










q Encapsulation Process by Manual Capsule Filling Machine by Hand:

For encapsulation of powder the following procedure is done with the help of Manual Capsule Filling Machineby hand in the capsule filling units of the industry:

Loading of capsule in the loading plate


Removal of caps of the shells


Filling of powder


Rejoining of caps of the shells




Sorting of Capsules


Polishing of Capsule


Machine name Machine specification Manufacturer Origin
Semi automatic Capsule filling machine Capacity: 15000-17000/hr Capsule fill

P+am pharmaceuticals

Automatic Capsule filling machine Capacity: 30000/hr Capsule fill Hanli Korea
Automatic Capsule filling machine Capacity:90000/hr

Capsule fill

Se jong Korea
S.S.Drum -Blender Capacity: 200 kg Gansons India.
Charge Vat Capacity: 50 kg Myth Bangladesh
Capsule polishing machine P+am pharmaceuticals India
Hand fill machine Capacity:8000/hr Pharmachem India


Figure: Capsule filling machine.

Number of tablet being produced in ARISTOPHARMA.

Trade name Generic name Strength
OMEP Omeprazole 20mg, 40mg
AZ Azithromycin 250mg, 500mg
ARISTOMOX Amoxacillin 250mg, 500mg
REUMACAP Indomethacin 25mg
TRAMACAP Tramadol 50mg

Dry Syrup

Dry syrup at Aristo Pharma Ltd is manufactured in a method namely,

Ø Direct Mixing,

q Flow chart for Direct Mixing for the manufacturing of Dry Syrup:

Crushing the sucrose in FITZ mill at 3000 rpm


Transfer of half portion of sucrose from step-1 into

a double cone blender by passing through a 20 mesh screen


Transfer of all other excipients in the blender

to blend for 30 minute


Transfer the mix from the double cone blender by

Passing through a 20 mash screen

q Machines used in the Dry Syrup Manufacturing unit:

Name of the Machine Function
Double cone Blender Blending/Mixing
FITZ Mill Crushing/ Milling
Dust Collector Removal of dust
Bottle Filling Machine Filling of Dry Syrup
Bottle Sealing Machine Sealing of Dry Syrup Bottle

q Condition for manufacturing Dry Syrup:

Relative Humidity: Not more than 45%.

Temperature: Below 250

Number of tablet being produced in ARISTOPHARMA:

Trade name Generic name Strength
AFIX Cefixime 100mg/5ml
AXIM Cefuroxime 125mg/5ml
STAFOXIN Flucloxacillin 125mg/5ml


Packing can be defined as an economical means of providing, presentation, protection, identification/information, containment, convenience, and compliance for a product during storage, carriage, display and use until such time as the product is used or administered.

After compression of tablets and coating [if required], the tablets are packed either in blister pack or in the strip.

v Purpose of packaging:

To increase the acceptability of the drug

To increase the stability of the drug

To minimize the transport/shipping hazards

To improve patients compliance

To improve the pharmaceutical elegance by use of special color or contrasting printing

At Aristopharma Limited, two types of combination is used depending on the upper & lower layers as well as product requirement. They are;

· PVC-Aluminium Blister

· Aluminium -Aluminium Blister

Besides blister packaging, at Aristo Pharmaceuticals Limited, other packaging includes;

Ø Striping

Ø Filling of tablets &capsules in bottles

Ø Labeling of bottles

Ø Secondary Packaging (Both on-line & off-line)

Ø Packaging of Ampoules

Ø Packaging of Vial

Packaging machineries:

Machine Name Machine specification No. of Machine Manufactured by Origin
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Buchon Korea
Automatic Blister Pack machine Capacity:


1 Hoong-A Korea
Automatic Blister Pack machine Capacity:


1 Hoong-A Korea
Automatic Blister Pack machine Capacity:


2 Elmapack India.
Strip Packing machine Capacity:


1 Gansons India.

fig: Aluminium foil

Primary Packaging Materials

Materials Sources
1. Polyvinyl Chloride [PVC], (PVC/PVC)

2. Polyvinylidine chloride [PVDC],

3. Aluminium Foil

ü korea

ü India,

ü Korea, Bangladesh

Different parts of a blister pack machine:

Different parts of a blister pack machine and their functions are giver in the following table:

Parts of blister machine Function
1. Base grid Draws the base material, which may be PVC, PVDC, ALUMINIUM FOIL.
2. Forming Station Forms blister in the base material either by hydraulic pressure or by air pressure and temperature
3. Hopper Tablets are kept in the hopper
4. Chute and Sprial Feeder Regulate the vibration so that table can move and fall in the feeding channel
5. Feeding Channel Feed the blister with tablet
6. Deduster Collects dust by creating vacuum
7. Scanner Scan the empty blister
8. Sealing station Seal the blister pack
9. Cooling station Cool the blister pack
10. Marking station Marks the empty blister
11. Code embosser Emboss code number
12. Slitting station Slit the blister pack
13. Web clump Draws the blister
14. Punching Station Cut the blister and slit down
15. Timer Regulate the passage of blisters
16. Detector Detect the empty packet
17. Rejector Rejects the empty blister packet
18. Conveyer belt Convey the pack for further processing.

Steps of Blister packing:

Ø Blister packaging:

We observed the blister packaging of Napa tab. (Paracetamol)

Foil soften by hot plate

Temp. 125-145°C

PVC sheet
Heating plate

Passed through desired dies plate which is kept

cold & air pressure is applied to make pocket for small time & desired shape is resulted (air pressure 6-8 bar)

Pressed by two plates simultaneously (upper plate temp. 160-180°C for PVC & lower plate is cold

Tablets or capsules are filled into the pockets

Alu-alu foil with

properly labeled

Passed through cutter
Desired blister pack

v Trouble shooting:.

– Preheating problem – malleability

– Forming problem

– Sealing problem

– Slitting problem – perforation

– Loading problem

– Air pressure

– Scanner problem

– Emboss problem

– Heat exchanger

– Feeding problem –

ü Chute channel

ü Gate transfer

ü Spiral

ü Brush

Ø Strip packaging:

We observed the strip packaging of ……….………..

v In-process check:

  1. Observation no.
  2. Leak test
  3. Room condition

a) Temperature & humidity

b) Segregation of bulk materials/finished packs

c) Product identity

d) line, display board

5. Aluminum foil leaving in machine and stock

6. Number of individual strips/blisters checked

7. Number of finished products checked

8. Quality and identity of components complient slip/labels/cartons/leaflets/outer labels/outer box/ spoon

9. Identity and appearance of product in packs

10. Quantity: No./volume/weight

11. Overprinting/embossing: batch no./MFD/Exp date/MRP

12. Label/carton with product name, batch no., Mfg date, price. Exp date

q Secondary Packaging (Both on-line & off-line):

Secondary packaging includes-

· Unit Cartooning with



-Spoon/dropper (in case of liquid)

-Security seal/Hologrammed Seal

· Master Cartooning with

– Unit cartoons

Sterile Department

Commonly the small volume parenteral or injectable products are filled in-

§ Ampoules

§ Vials

Generally the products are manufactured by two ways:

? Aseptically Sterilized

? Terminally Sterilize

Injectable Products in Ampoule:

Injectable Products are dispensed in ampoules following the procedure given below-

Ampoule De-boxing


Ampoule washing


Sterilization (in case of aseptically filled ampoules)


Ampoule filling (under laminar air flow)


Ampoule Sealing


Terminal Sterilization


Ampoule Inspection


Sealed Ampoules

q Ampoule Washing:

Sequence of “wash” by Ampoule Washing Machine:

DM water (inner-outer) ? Compressed air spray ? Distilled water ? WFI

Ampoule Filling & Sealing (under laminar air flow):

Ampoule on the filling belt


N2 flush ® Filling ® N2 flush ® Sealing by flame ® Ejection

(O2: LPG-1: 10)

q Ampoule Inspection:

· The white zone detects visually the black particles,

· The black zone detects the white particles.

· The volume is measured visually by taking 4 ampoules at a time in hand

q Different Sterilization Techniques & their uses:

Sterilization Technique Temperature

( 0C)

Exposure Time




Dry Heat Sterilization (DHS) 180 3 1.1 Vials
220 2.5 1.1
250 1 1.1
Steam Sterilization /Autoclave 121 0.5 1.1 Ampoules, Gloves, Filters, Gourmets


Sound protector, Mask, Surgical gloves, Cap, Apron, Electric Balance.


– Dust collector.

– SS Vat charge.

– SS Jug.

– SS funnel.

– Perforated tray.

Specialized location

The processes are done in fully aseptic area.

Production process flow

Manufacturing of injectable preparations require a clean room which should have the following standard

Class Cfu/m3 Particle of 0.5 micron/ft3 Particle of 5 micron /ft3
100 <1 NMT 100 0
1000 NMT 10