Cleanroom Monitoring Per Annex 1 Draft

Part 3 of 5 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The key location focus of...

Part 3 of 5 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft

There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here:

Cleanroom Monitoring

The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The key location focus of monitoring is at the manufacturing processes. The only connection with Cleanroom Qualification is that, as a secondary purpose, we also provide evidence of the performance of a cleanroom from the process point-of-view.

Because of the criticality of monitoring the manufacturing process, it is important to decide where to sample within the environment. There are many variables to consider including:

  • Product
  • Process
  • Facility
  • Equipment
  • Operations
  • Historical data
  • Qualification data
  • Microbial flora

To effectively create a monitoring plan, it is important to do a comprehensive risk-based analysis and consider what was previously found in the classification and qualification phases.

There is nothing new in Annex 1 regarding cleanroom monitoring methods. All grades must monitor total airborne particles at both ≥ 0.5 µm and ≥ 5.0 µm.

Cleanroom Verification

Regarding viable particles, the newest draft confirms what was presented in earlier Annex 1 revisions, which is we should use a combination of methods:

  • Settle plates
  • Volumetric air sampling
  • Gloves, gown, and surface sampling with swabs and/or contact plates
Cleanroom verifcation certification

Learn how our Advisory Services Team can help you with your cleanroom monitoring program.

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

  • Part 1 of 5, May 8, 2020: Cleanroom Classification
  • Part 2 of 5, May 13, 2020: Cleanroom Qualification
  • Part 3 of 5, May 19, 2020 Cleanroom Monitoring (you are here!)
  • Part 4 of 5 May 26, 2020: Advisory services for your cleanroom RA and steps
  • Part 5 of 5 May 29, 2020: Facility and data management solutions

You can also access this information by downloading the paper or watching the video.

See links to additional supporting resources below:

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Source: www.pmeasuring.com