A major part of the University of Iowa Pharmaceuticals’ (UIP) core business is clinical supply manufacturing and testing. Since 1974, UIPs’ 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 and testing operations are fully audited after clinical supply manufacturing and testing by the Quality Assurance Group.

University of Iowa Pharmaceuticals’ (UIP) 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.

Each manufacturing room has its own gowning/entry way that opens from a central staging area. Differential air pressures and single pass air, along with other measures including cleaning verification, are used to prevent cross-contamination. 

Special protective suites, wireless intercoms and video feeds, and supplied air respirators are used to protect employees from exposure to potent/toxic materials. The area is supported with a clean, dry compressed air system and a hot loop USP Purified Water system. 

All incoming air is HEPA filtered and humidity controlled and exhausted air is double HEPA filtered.  UIP can process controlled substances schedules I-V and most potent/cytotoxic compounds.

Tablet and capsule dosage forms can be produced using a variety of processes including roller compaction, wet granulation, and simple blending. 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.

Processing techniques available to prepare products include:

Screening, Milling or Micronizing

Roller Compaction

Low or High Shear Wet Granulation

Fluid Bed Granulation or Coating

Fluid Bed or Conventional Drying

Holt Melt Capsule Filling

Tablet or Capsule Pan Coating

Low or High Shear Blending

Capsule Banding

Once dosage forms are produced, UIP can sort them by weight to ensure the weight of every dosage unit is within the specified weight range. UIP has the ability to package finished products into bottles or bulk containers and apply labeling as desired. Clinical kits can be assembled and materials shipped directly to clinical sites.  UIP is fully capable of preparing comparator products via a variety of means.   

For more information about our clinical supply services and packaging services, please Contact Us.