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have totally separate premise for this. This has its own
Personnel & Material entry / exit area., separate RM
store with dispensing facility (Having reverse LAF), separate
PM store. Personnel entry has a air shower facility. This
area is having a IPQC section for routine quality checks.
It has separate water systems for DM & Distilled water.
The pipeline for the same is in loop and is made up of SS
316 L with internal electropolish.
DRY
POWDER INJECTABLE
It is well equipped with decartoning area, rotary washing
machine under LAF surrounded by class 100000 area. Sterilization
is through DHS(having HEPA Fillers) and Autoclave with arrangement
of steam passing through 0.2 m filter.
Sterile area is having Buffer zone, Mfg. Area and filling
area. Sterile area is fully epoxy coated & covered.
Dehumidification arrangement is provided. AHU is through
HEPA filler.
DRY
SYRUP
This area is having decartoning arrangement, bottle washing
with filtered air. Filling & Sealing is carried out
under controlled area having separate AHU with dehumidification
arrangement. It has inline labelling & packing equipments.
There is a common controlled area for manufacturing dry
syrups, capsules & tablet provided aithg all the requisite
equipments.
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