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The
facility for manufacturing of parenterals is having separate section for
each activity as follows: -
Water for Injection Manufacturing:
This includes water treatment such as softening, Reverse Osmosis, Demineralization,
and Distillation.
Store Area:
Separate stores for raw material with segregation for Quarantine, Approved
and rejected materials; plastic granules, packing materials and printed
packing materials.
Servicing Area: For materials feeding to sterile area.
Mixing Room:
Which includes solution preparation, and filtration (class 10000).
Filling Room: Having FFS machine (Class 10000).
Filling Area : Within FFS machine (Class 100)
Sterilization Area:
Having fully automatically controlled Autoclave for sterilization of filled/sealed
bottles.
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