Contract Aseptic Filling
Available from University of Iowa Pharmaceuticals
The University of Iowa Pharmaceuticals (UIP) has been preparing aseptically filled drug products for use in clinical trials and commercial sale for over 35 years and is registered with the FDA as a Drug Product Manufacturer. The aseptic filling area is capable of handling batch sizes ranging from a few hundred to 5,000 or more vials. The area is fully compliant with cGMP regulations and numerous products have undergone QP release for use in studies conducted in EU countries. The area is supported with a hot loop Sterile Water for Injection, USP system, 48 square foot Hull lyophilizer, Pure Steam Generator, Flexicon Filling, Stoppering, and Crimp Sealing Machines and other modern sterile processing machinery. UIP has the capability to terminally sterilize products. Once products are filled and sealed into vials, the products and vials are 100% visually inspected and can be labeled according to client specifications. The area is equipped with an isolator which allows potent and/or cytotoxic compounds to be processed. In addition, UIP is registered with the FDA and fully licensed to handle controlled substances schedules I-V. UIP has an integrated full support analytical testing laboratory that is able to perform in-process and finished product quality control testing, as well as, ICH compliant stability assessments.