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How do regulations affect closed systems?

29 November 2023
Drug Substance
Paul Osbourne
Global Change Facilitator

Closed systems are not a novel contamination control option. From a harmonized regulatory perspective, starting with ICH Q7, closed systems have been recognized for more than 20 years as a contamination control measure for low-bioburden active pharmaceutical ingredients. Closed systems are also endorsed as an engineering control solution with advantages over open processes within classified manufacturing areas.

Adherence to regulations is critical to correctly implementing closed systems and is the focus of the next chapter in BioPhorum’s Closure Playbook.

support the implementation of closed systems as a contamination control measure in the overall product protection strategy.

The Chapter’s comprehensive and detailed sections discuss:

  • ICH guidelines
  • WHO guidelines
  • PIC/S guidance
  • EU Eudralex guidelines
  • FDA guidance.

“The main motivating factors for drafting the Closure Playbook were patient safety and the development of a basis for a sound contamination control strategy,” said Marc Pelletier, Senior Fellow at CRB. “Other drivers included sustainability, and logical and appropriate system and facility design. Adherence to current regulatory guidelines is critical to the acceptance of the strategies presented in the Playbook. Evaluation and consideration of all pertinent guidelines was clearly included in the development of all plays presented in this guide.”

The level of implementation of closed systems clearly depends on the approach of the design and manufacturing teams in the overall contamination control strategy. There is no fundamental reason to discard closed systems based on regulatory acceptance. Closed systems are gaining popularity and becoming more widespread and a well-designed and operational closed system brings an adequate level of control over potential contamination of the product from the immediate manufacturing environment. With appropriate design and operational considerations in place, there is no logical reason to implement a classified environment for a closed system.

This is the second of several chapters of the Closure Playbook. Chapter 1: Introduction is available here and a Glossary is here .

Over the coming months, there will be further papers on the general philosophy of closed systems, how to apply the risk assessment model, the impact that closed systems may have on your facility design, and the design and documentation you need to use closed systems in an appropriately classified area.

For more information, download Chapter 2 here and contact Paul Osborne, Global Change Facilitator, at paul.osborne@biophorum.com

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