The sterile manufacturing facility at Coldstream Laboratories employs unique mobile isolator technology to allow flexibility in executing a wide variety of manufacturing processes. Our isolators facilitate handling of difficult-to-manufacture drug products and ensure the safety of our workforce throughout the production process. Mobile isolators provide an ISO Class 5 environment for aseptic processing and minimize human contact with the products we manufacture. This technology allows Coldstream to process a variety of potent drug substances such as cytotoxins in an adaptable alternative manufacturing setting when compared to standard clean rooms.
Mobile isolators are a relatively new technology that enclose all of the equipment necessary to manufacture sterile drug products in a highly controlled space (filling line, capper, lyophilizer, etc). Vaporized hydrogen peroxide (VHP) is used to decontaminate the internal surfaces and environment within our isolators, providing sterility assurance to our manufacturing operations. VHP is highly effective as it destroys a wide range of microorganisms, is able to rapidly achieve sterility and is highly sporicidal (even as low as 0.2 mg/L). Once the filling line is rendered sterile and components are transferred to the line, the isolators remain sealed and provide a physical barrier between personnel and the sterile environment.
As a manufacturing services provider, flexibility is key for Coldstream’s operations. Mobile isolators accommodate a variety of processes and enable rapid turnaround between batches. Coldstream’s mobile isolators not only allow for flexibility within the manufacturing realm, but also within the facility design itself. The mobility of our isolators allows for filling suite changes and updates to occur with little disruption to production activities.