Disposable System
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Components that directly contact the liquid medicine in the production process, such as silicone tubes, gaskets, filter elements and other contact materials are usually made of polymer materials, and there are certain risks in the process of them contact with the liquid medicine. BPOG (BioPhorum Operations Group) and BPSA (Biological Processing Systems Alliance) have issued recommended specifications for disposable system verification and the United States Pharmacopoeia has issued a draft for comments for USP <665> Polymer Components and System Contacted in the Manufacturing Process of Drugs and Biopharmaceuticals. We design a reasonable study plan and carry out the compatibility study of the materials directly contacting the liquid medicine based on the characteristics of the solution to evaluate the possible potential risks.
Reactor bag
Reservoir
Filter
Infusion tube, infusion line and injection line
Valve
Connector
