college of pharmacy

7 Greenhouse Road Kingston, RI 02881

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

URI
Think Big, We Do.
Rhode Island Seal
Follow us on TwitterVisit our Facebook page
 
 
ACPE logo

The University of Rhode Island Doctor of Pharmacy program is accredited by the Accreditation Council for Pharmacy Education.

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 ā€œDā€ 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).

Copyright © 2014 University of Rhode Island.

The University of Rhode Island
Think Big, We Do.
A-ZDirectoryContact UsJump to top