University of Iowa Pharmaceuticals (UI Pharmaceuticals) offers pharmaceutical product development, manufacturing, and testing services for sterile solutions, lyophilized products, tablets, capsules, and non-sterile powder, semisolid, and liquid products.
Because UI Pharmaceuticals is registered with the FDA as a Drug Product Manufacturing and Testing Facility, we are able to produce and test products intended for both clinical studies and commercial sales. Let us help you meet your non-sterile product manufacturing and testing needs.
UI Pharmaceuticals 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. UI Pharmaceuticals 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.
UI Pharmaceuticals Non-sterile Products area has four suites: one suite is dedicated to tablet and capsule coating, two suites are dedicated to the handling of potent/cytotoxic compounds, and one suite is divided into four separate manufacturing rooms and is designed for handling less potent/toxic materials.
The Non-Sterile Products Group has the capability to produce tablet and capsule dosage forms using a variety of processes. Batch sizes can range from a few hundred to hundreds of thousands of dosage units, depending on the dosage form unit weight and formulation blend density. Our largest blender will hold approximately 100 kg of product (depending on density). Non-sterile powders (up to approximately 100 kg), semisolids (up to approximately 100 kg), and liquids (up to 800 L) can also be prepared.
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