A major part of the University of Iowa Pharmaceuticals core business is clinical supply manufacturing and testing.  Since 1974, UIP quality clinical supply manufacturing and testing services have ensured that products are produced and tested under strict batch record, standard operating procedure, and cGMP controls. Manufacturing operations are fully audited after clinical supply manufacturing and testing by the Quality Assurance Group.

The Sterile Products Group has three ISO Class 6 Clean Rooms with ISO 5 (Grade A) aseptic work areas, one of which is interfaced with a 48 square foot Hull Lyophilizer with clean in-place and steam in-place capability.  Continuous viable and non-viable particulate monitoring is performed.

Sterile pharmaceutical products are prepared by sterile filtering and then aseptically filling solutions into glass vials. After filling, vials can undergo lyophilization if desired. UIP also has the capability to terminally sterilize aseptically filled solutions if desired. Batch sizes can range from a few hundred vials to up to 4,000 vials or 40 L of bulk solution (whichever is less), depending on the fill volume of the product. Differential air pressures, along with other measures, including cleaning verification and dedicated product contact equipment components, are used to prevent cross-contamination.  Because our fillers use peristaltic pumps and a single fill needle, line losses are low compared to larger operations. Vial sizes processed range from 2 mL to 100 mL (up to 50 mL for lyophilized products) and fill volumes can range from 0.5 mL up to 100 mL for liquid products.

We are able to process controlled substances schedules I-V and most potent and cytotoxic materials.  We routinely work with both large and small molecules.

Component preparation equipment includes:

Steriline vial washer
Cozzoli stopper washer
Getinge pass-through autoclave
Gruenberg dry heat oven

Key Clean Room filling, finishing, and processing equipment includes:

Flexicon FPC50 filling, stoppering, and crimp sealing machine (used for sterile liquid products)
Flexicon FP50 filling and stoppering machine (used for sterile lyophilized products)
Cozzoli Mini Monoblock vial filling and stoppering machine
West PW500 capper crimp sealing machine
Hull HYPRO 48 square foot lyophilizer

Once processed, all vials are wiped to ensure no residual product remains on the outside of the vials and 100 percent inspected for quality defects.  UIP has the ability to apply labeling to the finished vials. For smaller studies, patient kits can be assembled and materials can be shipped directly to clinical sites.  

To learn more about our sterile pharmaceutical products manufacturing and packaging capabilities, please Contact Us or review our Full Equipment List.