The University of Iowa Pharmaceuticals offers sterile pharmaceutical products development and manufacturing. Let us help you meet your needs.
The University of Iowa Pharmaceuticals (UIP) knows that sterile products are critical.
The Sterile Products Group has three ISO Class 6 Clean Rooms with Class 5 (Class 100) aseptic work areas, one of which is interfaced with a 48 square foot Hull Lyophilizer with clean in-place and steam in-place capability.
Sterile pharmaceutical products are prepared by sterile filling solutions into vials. After filling, vials can undergo lyophilization or terminal sterilization. Batch sizes can range from a few hundred to approximately 4,000 vials depending on the finished fill volume of the sterile products. Differential air pressures, along with other measures, including cleaning verification and dedicated product contact equipment components, are used to prevent cross-contamination.
Component preparation equipment includes:
Key Clean Room filling and finishing equipment includes:
UIP is capable of developing lyophilization cycles.
Once produced, all products are 100 percent inspected for quality defects. UIP has the ability to apply labeling to finished dosage units. If desired, patient kits can be assembled and materials can be shipped directly to clinical sites.