Cleanroom Classification v. Cleanroom Qualification v. Cleanroom Monitoring Per EU GMP Annex 1, rev 12 draft
Part 3 of 3 part blog
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 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
Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.
Particle Measuring Systems has complete cleanroom contamination control solutions to help you meet EU GMP including:
- Our Contamination Control Advisory Services who can conduct an expert Risk Assessment for your pharmaceutical processes
- PMS cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
- Customizable, turnkey Facility Monitoring Systems (FMS)
More EU GMP Annex 1 Information
https://www.pmeasuring.com/application-notes/annex-1-insights/
https://www.pmeasuring.com/blog/data-trending-annex-1-alert-levels/
Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1
Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ
Microbial Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)
Life Sciences & Pharmaceutical Industry Contamination Control
Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor
