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 126.96.36.199 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...