(capacity 100kg) (capacity 320kg )Fluid bed dryer Aeromatic Solace

Final mixer BHOLE mixer Not present

Solace multimill. Only one available for production

Russel shifter. Only one available for production

Types of granulation:Three types of granulation techniques are used­

• Dry granulation• Wet granulations

• Spray granulation

Dry granulation:This method is applied for drugs which do not compress well after wet granulation or those

which are sensitive to moisture. It may be performed following two ways­

In­plant training report. Page 5 of 40

Process one:1. Weighing.

2. Shifting.

3. Dry mixing.

4. Addition of disintegrants.

5. Lubrication.

Process two:1. Weighing.

2. Shifting.

3. Dry mixing.

4. compression to form slug.

5. Addition of disintegrants.

6. Lubrication.

Wet granulation:Wet granulation involves the massing of the powder mix using a solvent. The solvents used must

be volatile, so that they can be removed by drying, and nontoxic.

Steps involved:

1) Weighing.

2) Shifting.

3) Dry mixing.

4) Wet mixing.

5) Drying.

6) Crushing.

7) Addition of disintegrants.

8) Lubrication.

Spray granulation:This technique utilizes the technology of fluid bed drier. Heated air is blown through a bed of

unmixed powders and mixes the powders. Granulating liquid is pumped through a spray nozzle

over the particle.

In­plant training report. Page 6 of 40

Limitations and solutions:

Multimill and shifter frequently used in granulation technique. Production A and production Buse these two instruments by shifting. It reduces productivity.

Solution: To increase productivity these instruments are essential in both areas.

No final mixer (e.g. BHOLE MIXER) present in production area B; which is essential for qualityproduct.

Solution: It is essential to install a final mixer.

Compression:Compression of powder means reduction in bulk volume of a material as a result of displacementof the gaseous phase. Compression technique used for the manufacture of tablet.

Machines available:◊ Manestry (unipress):single rotary, 20 punch.◊ Clit machine:double rotary, 29 punch.◊ Se­Jong tablet machine:single rotary, 30 punch.

Tablet machine parts:Hopper.

Fed frame.

Feed paddles.

Main compression roller.

Compression sration.

Ejection cam.

In­plant training report. Page 7 of 40

Feed paddles.

Draw down cam.

Weight controller Fill station.

Pre­compression roller.

Ejection cam.

Take off blade.

Ejection station.

Take off chute.

Stages of compression:1. Feed frame over die.2. Fill.3. Scrapping.

4. Feed shoe pull back.5. Compression.6. Ejection

Tablet manufacture problem:Θ Punch filming and sticking.Θ Weight variation.Θ Capping/lamination.Θ Mottling.

Θ High friability.Θ Low hardness.Θ Variable hardness.Θ Bisection or embossing.

Limitations and solution:

Vacuum system used in both Clit and Se­Jong tablet machine to introduce granules, thatreduce the requirement of manpower & increase productivity – but it produce dust particle which

contaminate environment. Manestry tablet machine has no such problem.

Solution: Automatic hopper as Manestry may be used or protective covering my use to prevent dust

formation.

weight of tablet digitally controlled in both Manestry and Se­Jong tablet machine that reduce

weight variation and also easy to control than clit machine which is manually controlled.

Solution:Establishment of digitally control system for Clit machine, granules that have better flowing

property may be compressed without any weight variation.

Pre­compression roller reduce the air inside the granules, that reduce cracking problem –

In­plant training report. Page 8 of 40

absent in clit machine.

Solution:Granules with better compressibility can be easily compressed. If problem (Cracking) arises with

this machine direct compression (Ludipress LCE) agent may be used.

Tablet coating

It is the process by which a layer of polymer or sugar applied on core tablet for various reasons iscalled coating.

Types:o Sugar coating.o Film coating.o Powder coating.o Enteric coating.

Coating machines:◊ Manestry accela cota (capacity 150kg)

◊ Se­Jong (capacity 150kg)

◊ NR­cota (capacity 30kg)

Sugar coating:Sugar coating is the traditional method of coating tablet. It involves the successive application of

sucrose­based solutions to tablet cores in suitable coating equipment.

Steps: Actual steps Used steps

1. Sealing of the tablet cores.2. Sub­coating.3. Smoothing.4. Coloring.5. Polishing.6. Printing.

1. Application of liquor solution.2. Application of talc solution.3. Coloring.4. Polishing.

In­plant training report. Page 9 of 40

6. Printing.

Limitations and solutions:

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