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.
TORRENT PHARMACEUTICALS LTD. INDRAD
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.
TORRENT PHARMACEUTICALS LTD. INDRAD 1.1.1.2 INCOMING MATERIAL FLOW CHART
Raw material
Packaging material
Receipt
Verification
Sampling
Under test
Q.C. Testing
Approved
Rejected
For manufacturing
Return to supplier/destructio
TORRENT PHARMACEUTICALS LTD. INDRAD 1.1.1.3 PROCESS FLOW CHART MRN Checking
Approval Prod. & QA
Dispensing of raw material
Dex, VAC
Quarantine
Dex, VAC, Water
Pulverization and sifting
Quarantine
Compaction I.P.C. 1 AMP Load
Mixing
Binder Preparation & Addition Wet Mixing
Wet Granulation I.P.C. 1. Moisture content
I.P.C. 1. 2. 3. 4. 5.
Moisture content Size reduction Pour volume Tapped volume Content uniformity
I.P.C 1.Amp. Load
Steam, Air, Dex, VAC, Water
Drying Steam, Air
Sifting
Lubrication
Quarantine
.C.
Size Reduction
TORRENT PHARMACEUTICALS LTD. INDRAD
I.P.C. 1. 2. 3. 4. 5. 6. 7. 8.
Av. Wt. Wt. variation Thickness Hardness Disintegration Friability loss Dissolution A earance
Com ression
Coating
Q.C.
Ins ection
Quarantine
Q.A.
uarantine
Transfer to Packing
Dex, Vac
I.P.C. 1. 2. 3. 4. 5. 6.
Av. Wt. Diameter Thickness Disintegration Dissolution Appearance
TORRENT PHARMACEUTICALS LTD. INDRAD 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.
TORRENT PHARMACEUTICALS LTD. INDRAD
1.2.1.1.2 PROCESS FLOW CHART
Soft Gelatine
Steam, Water, Air, VAC
Gelatine Preparation
Medicament preparation
Q.C. Air
I.P.C. 1. Fill Wt. 2. Ribbon Thickness
Dehumidification
Encapsulation
Semi Drying
Drying
De- Oiling
Inspection Q.C. Quarantine
Packing Q.C. Bond Room
TORRENT PHARMACEUTICALS LTD. INDRAD 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.
TORRENT PHARMACEUTICALS LTD. INDRAD 1.2.2.2.2 PROCESS FLOW CHART
Hard Gelatine
Dispensing of raw material
Milling & Sieving
Blending Q.C. Air, VAC
Encapsulation
Inspection & Polishing Q.C
Quarantine
Packing Q.C
Bond Room
I.P.C 1. Fill Wt. 2. D.T.
TORRENT PHARMACEUTICALS LTD. INDRAD 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.
TORRENT PHARMACEUTICALS LTD. INDRAD 1.3.1.2 PROCESS FLOW CHART
Vials/Ampoules
Washing
Dispensing of raw materials
Snap off Caps
Washing
Bulk manufacturing I.P.C. 1.pH 2.Crystal Size 3.Turbidity 4.Bulk anal sis
Sterilization
Sterilization
Aseptic Filtration
Aseptic Filtration & Sealing I.P.C. 1.Fill volume 2.Seal integrity
Q.C. 1.Bulk analysis 2.Bulk sterility
Visual Inspection
Quality Assurance
Cold Storage (Incase of vials)
Packing
Q.A. Retained Samples Bond Room
Dispatch
TORRENT PHARMACEUTICALS LTD. INDRAD 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.
TORRENT PHARMACEUTICALS LTD. INDRAD 1.4.1.2 PACKING FLOW CHART
Packaging Flow Chart
P.M. Issue
Released Batch Issue
Printed/Secondary P.M. Coding Issue
Checking By Supervisor
Weight
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Blister/ Strip/ Ampoule/ Vial/ Labeling
On Line Checking
Secondary Packing
Counter Checking By Weight
Final Packing
Identity
