Coldstream Laboratories utilizes a 22,000 square foot state-of-the-art parenteral manufacturing facility to provide advanced cGMP manufacturing services to meet your needs. Our facility design is centered around mobile isolator technology, providing an ISO 5 environment during processing, as well as product containment for potent, cytotoxic, and radiolabeled products.
Our facility is FDA approved and our regulatory history includes successful completion of numerous client audits.
Parenteral sterile fill/finish:
Bosch vial filler with capper (maximum output of 900 vials/hour)
Hull lyophilizer (48 square feet)
Finn Aqua (Steris) autoclave (38 square feet)
Depyrogenation oven (48 square feet)
Chase Logeman Filler with Capper (coming soon)
Water for Injection Hot Loop Distribution System
Clean Steam Generation and Distribution
Medical Grade Air and Nitrogen Distribution Systems
Refrigerated and Ultra Low Temperature (ULT) Storage
Emergency Power Generator
ISO 7 (Class 10,000) formulation room
ISO 5 (Class 100) biological safety cabinets in each formulation room