College of Pharmacy

7 Greenhouse Road Kingston, RI 02881

pharmcol@etal.uri.edu – Office: 401.874.2761 Fax: 401.874.2181

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cGMP Facility

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.

Equipment

The Facility

  • 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
  • Bioreactor
  • USP Class1 purified water and clean compressed air
  • Exhaust air filtered

 

Potential Products

  1. Pharmaceutical product areas; including liquids, oral solids, semi-solids, bio-erodible systems, cytotoxic agents, and USP 797 low-, medium-, and high-risk compounding.
  2. Cosmetics, foods, nutritional products, and dietary supplements.
  3. Veterinary products.
  4. Biopharmaceuticals using single use technologies (excluding sterile fill).

Contact Us

Clinton Chichester
Co-Director, Human Patient Simulation Center
Professor and Chairman, Biomedical & Pharmaceutical Sciences
401.874.5034
chichester@uri.edu

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