How to Mitigate the Contamination Risk in Biopharma Production

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 a necessary destruction of their highly valuable product due to in-process contamination.

Benefits of single-use solutions in combination with overmolding technology

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.

Tailored tube-to-container interfaces (also available as “flex caps” for glass bottles) eliminate the limitations of standard port caps while mitigating the contamination risk at an all-new market level.
Custom-designed overmolding tube-to-tube connections with seamless integration ensure perfect laminar media flow through gateways during filling and emptying processes by avoiding edges, protrusions or dead zones in the flow path.
Tamper-proof tube connections require no cable ties and ensure a closed system environment excluding subsequent opening.
Maximum reliability and easy container handling in sampling, manufacturing, storage and (cold chain) transportation processes are ensured by an overmolding portfolio of integrated tube fixations and protection caps including a patented, tamper-evident integrity seal.

Thanks to the open architecture the fully scalable technology spectrum enables the integration of previously validated components such as tubing. This considerably helps reduce overall system costs and offers a closed, tamper-proof system for 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.

Securing the supply chain

Manufacturing, assembly and packaging processes in certified clean rooms are a basic prerequisite for serving pharmaceutical and biopharmaceutical customers. In Europe, Parker Prädifa operates two clean room 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.

Additional information:

Industry Page: www.parker.com/praedifa-biopharma
Brochure: Single-Use Systems – Tubing Manifolds and Container Systems
Online Product Catalog: Single Use Systems
Webinar: Risk Mitigation in Biopharma through Single-Use Fluid Management Systems

Posted by Dr. Heinz-Christian Rost, market unit manager life sciences, Engineered Materials Group Europe, Prädifa Technology Division