UI Pharmaceuticals operates a new, 16,000 square foot sterile products manufacturing facility — fully operational and qualified to support your large-scale sterile fill/finish and lyophilization needs.
Our Sterile Products Group offers both clinical supply and small-scale commercial product manufacturing and testing services, with the capacity and expertise to meet the demands of today's pharmaceutical development pipeline.
State-of-the-Art Sterile Processing Facility
Our facility features two fully automated, ISO 5 integrated isolator lines, each interfaced with a Telstar Lyophilizer with clean-in-place (CIP) and steam-in-place (SIP) capability. This infrastructure supports rigorous contamination control and consistent, reproducible manufacturing outcomes.
Sterile Fill/Finish Capabilities
Sterile pharmaceutical products are prepared by sterile filtration and aseptic filling of solutions into glass vials within closed isolators. Filled vials can undergo lyophilization (freeze-drying) if required, and UI Pharmaceuticals also has the capability to terminally sterilize solution products.
Key operational parameters:
Batch sizes from a few thousand vials up to approximately 20,000 vials or 200 L of bulk solution (depending on vial size)
Vial sizes processed: 5 mL to 100 mL, with other vial configurations available
Fill volumes: 0.5 mL to 100 mL for liquid products
Differential air pressure controls and dedicated product-contact equipment components prevent cross-contamination
Peristaltic pump fillers minimize line losses compared to larger-scale operations
We routinely process controlled substances (Schedules I–V) and potent/cytotoxic materials, and work with both large and small molecules.
Vial filler, stoppering, and vial capping machines
TelStar Lyomega 80ST DH-RC 5.4/140 lyophilizers with Lyogistics Rx RVLus 400 Loaders, Tee switches, and conveyors (sterile lyophilized products)
Cleaning & Decontamination
Steris Reliance 680PG Pharmaceutical Grade Washer
VHPM1'000-S/T4 Decontamination manifold system linked with a Bioquell VHP system
After manufacturing, all vials are automatically washed by an External Vial Washer before leaving the isolator lines. 100% visual inspection is performed on every vial for each batch.
Labeling, Packaging & Clinical Distribution
UI Pharmaceuticals can apply labeling to finished vials and, for smaller clinical studies, assemble patient kits for direct shipment to clinical sites — streamlining your clinical supply chain from manufacturing to patient delivery.
Lyophilization Cycle Development
Our team has extensive experience developing lyophilization cycles. We use Lyotherm2, Lyostat2, and TA Instruments Q20 DSC instrumentation to determine critical lyophilization parameters. Trial batches are processed on our TFS LyoStar II and/or Virtis Advantage development lyophilizers.