Cleanroom Monitoring System per Annex 1 draft

Cleanroom Monitoring System per Annex 1 draft

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:

Cleanroom Monitoring

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.

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


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:

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

 See links to additional supporting resources below: 

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:

Get a Quote

More EU GMP Annex 1 Information



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

Pharmaceutical Environmental Monitoring Systems

Microbial Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1

Cleanroom Process Risk Assessment per Annex 1

Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)

Contamination Control Strategy and Annex 1


Life Sciences & Pharmaceutical Industry Contamination Control

Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor

Annex 1 Latest Draft Revision Updates

Explore Other Topics

Search Knowledge Center: