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Let Us Assess Your Parenteral Manufacturing Needs

Parenteral Manufacturing

parenteral manufacturing 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.

Aseptic Filling Capabilities:

Parenteral sterile fill/finish:

  • Vials from 2 - 100 mL
  • Dispensing volume as low as 0.5 mL up to 50 mL

Parenteral Lyophilization:

  • Vials from 2 - 100 mL

Equipment:

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)

Systems:

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

Features:

ISO 7 (Class 10,000) formulation room
ISO 5 (Class 100) biological safety cabinets in each formulation room