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 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 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.

Securing the supply chain

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.

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

Related articles:
Overmolding Technology Enhances Safety of Single-Use Systems
Innovative Clean Room Production Meets Demands of Medical and Pharmaceutical Industries
How Tailored Single-Use Fluid Management Systems Benefit Biopharma Manufacturers

• Healthcare and Life Science Technology
• Sealing and Shielding