The Coldstream Laboratories manufacturing facility utilizes isolator technology for aseptic processing in a 22,000 square foot state‐of‐the art building. Our facility is FDA-approved and our regulatory history includes successful completion of numerous client audits.
The core of the aseptic area is ISO-8, equipped with isolators to provide an ISO-5 environment for aseptic operations. Each major piece of equipment (lyophilizer, autoclave, depyrogenation oven, and parts washer) is coupled with a stationary transition isolator to provide an aseptic environment during transfer of materials and product. Transport isolators are employed to dock with the stationary transition isolators to shuttle material and product to and from the stationary filling/stoppering/capping isolator. This process allows maximum flexibility while providing an aseptic environment for the product, as well as containment for personnel safety.
In addition to the isolators, the core area also contains two formulation rooms that are classified as ISO-7. The formulation rooms are each equipped with Biological Safety Cabinets that can be used as required in support of aseptic operations.
Major utilities include a Water for Injection System, Clean Steam Generator, Compressed Air System, Emergency Generator, Waste Neutralization System, and five HVAC units to service the aseptic and administrative areas. The building is operated and maintained through a Building Management System (BMS).
Storage of materials is provided in a temperature controlled warehouse. Storage of temperature sensitive materials is provided via upright units with 2‐8°C and ‐20°C storage currently available.
The manufacturing facility also has a full service microbiology lab on site.