Part 3 of 3 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 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.
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
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 3, May 8, 2020: Cleanroom Classification
- Part 2 of 3, May 13, 2020: Cleanroom Qualification
- Part 3 of 3, May 19, 2020 Cleanroom Monitoring (you are here!)
You can also access this information by downloading the paper or watching the video.
See links to additional supporting resources below:
- Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
- Video: Cleanroom Monitoring Updates Discussion
- Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
- Blog: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line
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