BLOG: Considerations and Steps for Building a Contamination Control Strategy – Series Part 4 of 4

BLOG: Considerations and Steps for Building a Contamination Control Strategy – Series Part 4 of 4

Design a cleanroom according to Sterility Assurance Principles

contamination control strategy ccs

In Part 1 of this blog series we learned how contamination is defined and what it means to control potential contamination. In Part 2 we discussed how the EU GMP Annex 1 2020 Draft Guidance regards CCS. In Part 3 we talked about how to define the potential root causes of contamination (in 3 steps). Finally, in Part 4 we will discuss how to interpret and apply the data gathered in the previous steps to design a cleanroom that conforms to Sterility Assurance Principles and is unique to your process. (We will call this “Step 4”.)

Define the actions to be implemented and their controls:

Step 4 in building a CCS is the implementation stage. After the potential root causes have been identified, we will need to assign risk to those root causes. These risk designations are the critical indicators we will use to build CCS into the cleanroom design.

Contamination Control Strategy ccs

From the Risk Evaluation above, a Mitigation Plan (with actions) can be put in place with Controls built around them to provide feedback on their effectivity, as demonstrated here:

Contamination Control Strategy ccs

And last, but not least, maintain regard for the input of all operational and quality voices in building the Contamination Control Strategy process.  Each voice has a unique and valid perspective that is critical to building a robust plan that will ensure feedback loops of control supporting your Sterility Assurance Principles.

Thanks for joining us for this review of Contamination Control Strategy. If you have further questions please visit  our CCS FAQ’s page.

Also, Learn how Particle Measuring SystemsCleanroom Contamination Control Advisory Services Team can help you identify problems and suggest solutions to preserve the high quality of your products and processes.

Want to read more? Jump to other released PMS posts in this series:

Additional Resources

Pharmaceutical Data Management for Root Cause Identification in Critical Environments (Case Study)

EU GMP Annex 1 – Rev. 12 2020 – Insights and Updates

Explore Other Topics

Search Knowledge Center: