Biotechnics Research produces a variety of sera products for use in cell culture media, production of biological and diagnostic products, and other laboratory procedures which demand the finest quality serum available. In order to maintain consistent quality in our serum products, strict quality assurance of each production lot is maintained. Written procedures in accordance with Good Manufacturing Practices (GM Ps) help ensure product quality throughout the production process.

All individual lots of raw serum are evaluated and must meet established specifications before they are released for production. Sterile product containers are evaluated to ensure that they meet specifications prior to vialing of the final product. Biological indicators are used as part of the quality assurance measures during these sterilization processes. This monitoring provides assurance that each lot is prepared according to protocol and meets design specifications.

The filtration process used in production is validated. Each sterilizing filter used during a production run is pre and post-run integrity tested by either a bubble point or pressure hold test.


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