Mitigating the contamination risk in biopharmaceutical manufacturing is essential for two reasons: Obviously, product safety for patients is of paramount importance, but manufacturers must also be protected against substantial financial losses, resulting, for instance, from necessary destruction of their highly valuable product due to in-process contamination.
For effective and cost-efficient mitigation of contamination risks within the process chain, Parker Prädifa offers an extensive portfolio of “intelligent” and customizable solutions for a wide range of applications in upstream and downstream processes using advanced, proprietary overmolding technology.
Thanks to the open architecture the fully scalable technology spectrum enable the integration of previously validated components such as tubing. This considerably helps reduce overall system costs and offers a closed, tamper-proof system for the protection of the product.
Every single-use solution is precisely adapted to the previously validated production framework and offers substantial overall system cost reduction potential.
Manufacturing, assembly, and packaging processes in certified cleanrooms are a basic prerequisite for serving pharmaceutical and biopharmaceutical customers. In Europe, Parker Prädifa operates two cleanroom production facilities: one in Sadska (Czech Republic) certified according to ISO 14464 Class 7 and one in Pleidelsheim (Germany) certified according to ISO 14464 Class 8.
Posted by Dr. Heinz-Christian Rost, market unit manager life sciences, Engineered Materials Group Europe, Prädifa Technology Division
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