PBIC site is a state-of-the-art API manufacturing facility, designed to meet US FDA, WHO and other cGMP requirements and expectations. HVAC system with terminal HEPA filters to Grade D (ISO Class 8) clean rooms, USP Purified Water generation, storage and distribution system. Utilities are able to handle temperature gradient from -30oC to +160oC (4 chillers and 4 thermal units).
In-house analytical and micro laboratories to support development, technology transfer and production.The area is equipped with air ventilation system, Walls are forced concrete, floors are forced concrete covered with self-leveling epoxy. Ceiling is constructed from sandwich panels and doors are painted steel, The building is explosion proof designed according to International Electrical Code (IEC).
The Open Processing Manufacturing Area is equipped with reactors from 2000 to 8000 L of various types (13 Stainless Steel 316L Reactors and 4 Glass Lined Reactors), one Centrifuge for Intermediate / Product Isolation and one vacuum tray dryer.
The Finishing Production Area is equipped with: Two centrifuges for intermediate and finished product isolation, One vacuum tray dryer, One milling machine, One CIP unit & Utensils dryer (for scoops, trays, etc.).