The University of Iowa

UI Pharmaceuticals Provides Sterile Fill/Finish and Lyophilization Services

University of Iowa Pharmaceuticals (UIP) offers pharmaceutical product development, manufacturing, and testing services for sterile solutions and lyophilized products.  Because UIP is registered with the FDA as a Drug Product Manufacturing and Testing Facility, we are able to produce and test products for both clinical studies and commercial sale.  Let us help you meet your sterile fill/finish and lyophilization needs.

a close up of a sterile products line
The University of Iowa Pharmaceuticals (UIP) knows that sterile processing is critical and offers both clinical supply and small scale commercial product manufacturing and testing services.

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 (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

open lyophilizer

UIP has extensive experience developing lyophilization cycles. We have a Lyotherm2, Lyostat2, and TA Instruments Q20 DSC that are used to determine critical lyophilization parameters, and then trial batches are processed in our TFS LyoStar II and/or Virtis Advantage development lyophilizers. To learn more about our lyophilization cycle development capabilities, please consult our Lyophilization Cycle Development Page.

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 clinical 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.