69110174 Tablet Flow Chart

TORRENT PHARMACEUTICALS LTD. INDRAD

FORMULATION PLANT:

1. MANUFACTURING ACTIVITIES

Manufacturing activities proposed in the project include various processes as a part of

manufacturing Tablets, Hard-shell Capsules and Soft Shell Capsules, Injections

Ampoules and Vials, bulk drugs. The activities shall also include operation of various

utilities. The manufacturing process is described in details in following sections. The list

of products (existing as well as proposed) and their capacity is given in Table 1.2.

1.1 MANUFACTURING PROCESS, FLOW DIAGRAM & MASS BALANCE

Product wise detailed description of manufacturing process, process flow chart, chemical

reactions involved and mass balance diagram etc. are as follows.

1.1.1 TABLETS 1.1.1.1 MANUFACTURING PROCESS

1. Shift and pulverize all raw materials to be used in the product, which are

dispensed after weighing.

2. Mix the active material with diluents using mixer. If necessary do geometrical

dilution or triturating.

3. Prepare binder solution or paste using binder in appropriate solvent as per

formulation requirement.

4. Bind the mixed powder using binder in mixer.

5. Wet granulate the mix mass using communating mill fitted with perforated screen.

6. Dry the wet granules in fluid bed dryer controlling temperature of inlet air.

7. Shift the dried granules through appropriate sieve and pulverize the oversize

granules in communating mill.

8. Lubricate the shifted granules with freshly shifted lubricants using the mixer.

9. Compress the lubricated granules on suitable rotary compression machine fitted

with appropriate die-punch set.

10. If required film coat the tablets using Autocoating machine controlling spray rate

and drying temperature.


11. If required sugar coat the tablets using conventional sugar coating pan controlling

average weight of the tablet.

12. Inspect the ready tablets on inspection belt.

13. Prepack the tablets suitably in blister, strip or bottles followed by post packing in

cartons or boxes.

14. Shrinks wrap the boxes and pack them finally in corrugated boxes suitable for

dispatches.


1.1.1.2 INCOMING MATERIAL FLOW CHART

Raw material Packaging material

Return to supplier/destructio

Q.C. Testing

Sampling

Verification

Receipt

Under test

For manufacturing

Approved Rejected


1.1.1.3 PROCESS FLOW CHART

Dispensing of raw material

Approval Prod. & QA

Dex, VAC

MRN Checking

Quarantine

Pulverization and sifting

Mixing Compaction

I.P.C. 1 AMP Load

Binder Preparation & Addition

Wet Mixing I.P.C 1.Amp. Load

Size Reduction

Wet Granulation

Drying

Sifting

Lubrication

Dex, VAC, Water

Steam, Air, Dex, VAC, Water

Steam, Air

I.P.C. 1. Moisture content 2. Size reduction 3. Pour volume 4. Tapped volume 5. Content uniformity

I.P.C. 1. Moisture content

Quarantine

Quarantine

Q.C.


Q.C.

CompressionI.P.C.

1. Av. Wt. 2. Diameter 3. Thickness 4. Disintegration 5. Dissolution 6. Appearance

Coating

I.P.C. 1. Av. Wt. 2. Wt. variation 3. Thickness 4. Hardness 5. Disintegration 6. Friability loss 7. Dissolution 8. Appearance

Dex, VacInspection

Quarantine

Q.A. Approval

Quarantine

Transfer to Packing


1.2.1 CAPASULES

1.2.1.1 SOFT SHELL CAPSULE

1.2.1.1.1 MANUFCTURING PROCESS

1. Dissolve the medicament in appropriate solvent by continuous stirring.

2. Filter the solution through 150-mesh screen.

3. Soak the Gelatin and melt in a Gelatin melter with controlled temperature.

Process the Gelatine to form air free, semisolid, pourable paste.

4. Encapsulation the medicament on rotary encapsulator with the Gelatine paste

using appropriate set of die roll or segment. Control the ribbon thickness and

fitted weight of capsules.

5. Degrease the capsules and dry them in the room having controlled humidity and

temperature. Degrease the waste ribbon after chopping and recycle it.

6. Inspect the capsule on inspection table.

7. Prepack the capsule in blister, strip or bottles followed by post packing the printed

cartons or boxes.

8. Shrink wrap the packs and pack finally in corrugated boxes suitably for

dispatches.


1.2.1.1.2 PROCESS FLOW CHART

Steam, Water, Air, VAC

Soft Gelatine

Gelatine Preparation

Medicament preparation

Encapsulation

Q.C.

I.P.C. 1. Fill Wt. 2. Ribbon Thickness

Semi Drying

Drying

De- Oiling

Inspection

Quarantine

Packing

Bond Room

Air

Dehumidification

Q.C.

Q.C.


1.2.2.2 HARD SHELL CAPSULE

1.2.2.2.1 MANUFCTURING PROCESS

1. Dissolve the medicament in appropriate solvent by continuous stirring.

2. Filter the solution through 150 mesh screen.

3. Soak the Gelatine and melt in a Gelatine melter with controlled temperature.

Process the Gelatine to form air free, semisolid, pourable paste.

4. Encapsulation the medicament on rotary encapsulator with the Gelatine paste

using appropriate set of dieroll or segment. Control the ribbon thickness and fitted

weight of capsules.

5. Degrease the capsules and dry them in the room temperature and temperature.

Ribbon after chopping and recycle it.

6. Inspect the capsule on inspection table.

7. Prepack the capsule in blister, strip or bottles followed by post packing the printed

cartons or boxes.

8. Shrink wrap the packs and pack finally in corrugated boxes suitably for

dispatches.


1.2.2.2.2 PROCESS FLOW CHART

Dispensing of raw material

Milling & Sieving

Blending

I.P.C 1. Fill Wt. 2. D.T. Encapsulation

Inspection & Polishing

Q.C.

Quarantine

Packing

Bond Room

Hard Gelatine

Air, VAC

Q.C

Q.C


1.3.1 INJECTION

1.3.1.1 MANUFCTURING PROCESS

1. Dissolve the medicament in appropriate solvent. Take necessary measure to

reduce the biomass. Control pH of the solution.

2. Subject the bulk medicament to sterile filtration or any other suitable method of

sterilization.

3. Wash the Ampoules, Vials or caps suitably and subject them to sterilized cycle.

4. Carryout accepting filling and sealing of bulk medicament in vials or ampouls

using appropriate injection filling machine. Control the fill volume and aseptic

condition.

5. Subject the filled ampoules to leak test.

6. Carryout visual inspection of individual unit against light.

7. Label the ampoules/ Vials suitably on labeling machine.

8. Prepack the ampoules/Vials in blister or cartons followed by packing in boxes.

9. Pack finally in corrugated boxes suitably for dispatches.


1.3.1.2 PROCESS FLOW CHART

Vials/Ampoules Dispensing of raw materials

Snap off Caps

Washing Washing Bulk manufacturing

Sterilization

Aseptic Filtration

Aseptic Filtration & Sealing

Leak test/SterilizationQ.C. 1.Bulk analysis 2.Bulk sterility

I.P.C. 1.Fill volume 2.Seal integrity

Sterilization I.P.C. 1.pH 2.Crystal Size 3.Turbidity 4.Bulk analysis

Visual Inspection

Quality Assurance

Cold Storage (Incase of vials)

Packing

Q.A. Retained Samples

Bond Room

Dispatch


1.4.1 PACKAGING OF TABLETS, CAPSULES AND INJECTION

1.4.1.1 PACKING PROCESS

1. Packaging material issued from packaging material store near packaging department.

2. Released batch issued from manufacturing department (tablet/Capsule/Injection).

3. Tablet/Capsule packed in blister/strip packing using two type of film (Printed

foil/Plain Foil/ PVC).

4. Issued packaging material from P.M. store subject to overprint B.No., Mfg Exp.,

Retail Price required matter from Export Department.

5. Released batch issued from manufacturing department subject to check it identity and

weight.

6. Packing activity divided in two, primary packing and secondary packing.

7. After primary packing meant for online checking and then secondary packing on belt.

8. Packed goods on belt for counter checking & then secondary packing on belt.

9. After checking weight on shrink pack used for final packing.

10. Packed goods, strapped and transfer to bonded store by internal transfer slip.


1.4.1.2 PACKING FLOW CHART

Packaging Flow Chart

P.M. Issue Released Batch Issue

Printed/Secondary P.M. Coding Issue

Weight Identity

Checking By Supervisor

Primary Packing

Blister/ Strip/ Ampoule/ Vial/ Labeling

On Line Checking

Secondary Packing

Counter Checking By Weight

Final Packing

69110174 Tablet Flow Chart

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