Located in of the Pharmacy Building
The cGMP Manufacturing Facility
- A 7,000 sq.ft laboratory and pharmaceutical production facility.
- 1,500 sq.ft cGMP Analytical and Stability Laboratory.
- Designed based on US FDA and EU guidelines to support scaled manufacture of commercial products for Phase 1, 2, and 3 clinical trials and scaled commercial manufacturing.
- Three individual process HVAC HEPA filtered clean rooms suitable and support facilities with in-process testing, equipment storage and wash, material management and personnel/material transition.
- Process rooms ISO Class 8 EU Grade C
- Airlock/gowning ISO Class 8 EU Grade C
- Clean Corridor ISO Class 9 EU Grade D
- In Process Lab ISO Class 9 EU Grade D
- Main airlocks ISO Class 9
- VSP-16 Mini Rotary Tablet Press- TSM “D” Tooling
- CP-501 Advanced Single Tablet Press
- Lab V-Shell Interchangeable (1CBM & 2 CBM) Blenders
- LIH-3 Automatic Tablet Hardness Tester
- USP Class1 purified water and clean compressed air
- Exhaust air filtered
- Pharmaceutical product areas; including liquids, oral solids, semi-solids, bio-erodible systems, cytotoxic agents, and USP 797 low-, medium-, and high-risk compounding.
- Cosmetics, foods, nutritional products, and dietary supplements.
- Veterinary products.
- Biopharmaceuticals using single use technologies (excluding sterile fill).