The University of Iowa Pharmaceuticals offers sterile pharmaceutical products development and manufacturing. Let us help you meet your needs.

 

Sterile Products

Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

Sterile Liquid FillingSterile Pharmaceutical Products

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:

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

Key Clean Room filling and finishing equipment includes:

  • Flexicon filling
  • Stoppering
  • Crimp sealing machine
  • Cozzoli vial filling
  • Stoppering machine
  • Westcapper crimp sealing machine

UIP is capable of developing lyophilization cycles.

 

Hull 48 Square Foot HY-PRO LyophilizerOnce 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.

 

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