Advanced Aseptic Success Story

Delivery Method
Conceptual / Detailed Design, Potent Compound & cGMP Risk Assessment, Process Equipment URS & Specifications, Construction Administration, Validation Master Planning, Compound Evaluation/Categorization (OEL)

Objective
Construct a new, 35,000sf, dedicated manufacturing facility for the production of OSD and Parenteral cytotoxic pharmaceutical products.
Total Site: 58,520sqmt
Cyto Block: 2,850spmt
Anti-hormonal Block: 1,500sqmt
Utility Block: 858sqmt

Capabilities
The new cGMP facility included two dedicated areas, one for oral dosage and the other for parenteral products for international market distribution.  Solid dosage capabilities included wet and dry granulation through compression, coating, and final packaging. Parenteral operations supported formulation and primary/secondary packaging. Various isolation technologies were assigned to provide for primary containment and facility elements provided transition area supporting secondary containment and cGMP zoning (FDA , EMEA, MHRA, WHO). Produced materials will be used for submission and commercial use with batch sizes ranging from 0.75kg to 60kg.