UA-44035381-1

Facilities

Our products are used in critical applications in pharmaceutical, biopharmaceutical and other industries. In order to meet the expected standards with respect to bioburden, endotoxin levels, particle/fiber release, and contribution to impurity profile from filters, these products are produced and packaged in GMP facilities with ISO class 7 clean room areas certified by external agencies and monitored internally for viable and non-viable particles and air flows. Employee hygiene, change rooms, gowning and continuous monitoring of the areas is an essential part of these facilities.

These facilities have been designed for unidirectional work flow with class 8 corridors around class 7 production areas, with appropriate change rooms for personnel and pass boxes for material movement. The materials of construction allow easy cleaning and prevent buildup of dirt and dust.Well defined and organized clean storage space with separate ISO class 8 storage areas for quarantine and incoming testing is provided and separate finished goods store is situated next to the dispatch section. Transfer of finished goods from manufacturing areas to storage is through pass boxes.