Cleanroom Monitoring v. Classification v. Cleanroom Qualification 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 a cleanroom monitoring system 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 the PMS Advisory team can help you with your cleanroom monitoring program.
