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Key criteria include: In-house lot testing against USP compendial requirements: sterility (USP ), bacterial content, conductivity, TOC, and BAC concentration Certificate of Conformance for every production lot , not just on request Clearly labeled lot numbers and expiration dates on every vial Full lot traceability from raw materials to final release Documented manufacturing procedures and process validation As a practical example of this standard, TM BioWater operates a proprietary manufacturing platform purpose-built for repeatability and process control, testing every lot in-house against compendial requirements and issuing a Certificate of Conformance for every production lot
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