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Quality Control
After purification, plasma is separated into different plasma therapeutics. Production is controlled through written batch records ensuring each batch of plasma protein therapeutics is made consistently by defined procedures and to approved specifications. Finished therapies are then packaged for distribution, and regulatory authorities check each lot before approving them for release. Only biotherapies meeting all final requirements are approved for release.
The elimination and inactivation of viruses in the manufacturing process of products is achieved by a series of measures. It starts with the selection of donors and testing of donations, proceeds with purification, virus inactivation and elimination and is completed by multiple levels of quality control. Each step of the manufacturing process contributes to the safety of our products. Over the last 25 years, the risk of virus transmission by the application of plasma-derived products has been nearly eliminated.
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