The University of Iowa

UI Pharmaceuticals Provides Sterile Fill/Finish and Lyophilization Services for Commercial Products

Although the bulk of UI Pharmaceuticals projects over the years have supported clinical studies, small scale pharmaceutical manufacturing and testing for commercial products has been performed for most of the last 20 years.  A sterile solution product is currently being produced in our facility and being sold commercially in the US.

Sterile solution being filled into vials in a Clean Room.
UI Pharmaceuticals is registered as a drug product manufacturer with FDA and has produced and tested a number of sterile products that have been sold commercially over the years.  We are currently working with additional customers producing and testing product currently being sold commercially in the US or working through the registration process.

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.

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 (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:

Vials being held in an inspection booth.

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
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.  Products are shipped to third parties as bright stock for final labeling and commercial finish.

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