Cleanroom Environmental Monitoring

Any pharmaceutical manufacturing company operating within or dealing with other businesses operating within the EU, must comply with the EU GMP Annex 1. The latest revisions of these regulations cites continuous Environmental Monitoring (EM) as critical in compliance for one simple reason: it helps ensure medicines and medical devices are safe for human use.

EM covers many aspects of the pharmaceutical manufacturing environment including temperature and humidity control, consistent air pressure between controlled environments and both non-viable and viable particle monitoring. Viable particle monitoring is more complicated due to the 5-day incubation process necessary to determine which particles collected are actually viable colony forming units (cfu). Real-time continuous data, from a real-time, continuous airborne microbial monitor,  will help with the root cause identification of contamination.  Delivering alerts in-time to reduce the risk of product loss. 

Compliance with the EU GMP Annex 1 regulations requires a pro-active EM program. This complex legislation is subject to regular change, which makes comprehensive, continuous EM an essential protocol together with equipment and process validation.

• New EU GMP Annex 1 impact for large Pharma
• EU GMP Annex 1 update: part 
• Continuous EM is key in Annex 1
• 6 Key Considerations for crafting a Contamination Control Strategy in line with GMP Annex 1
  
  

As outlined in the latest EU GMP Annex 1 regulations, a combined approach to environmental monitoring is by far the most effective way to achieve compliance.

Human intervention is the main cause of contamination in cleanrooms and other critical areas. Continuous active air sampling within grade A spaces throughout an entire production run, supported by background active and passive sampling at key points, is required to monitor for any possible contamination of undetermined origin.

• Passive and active air sampling in EM
• Agar desiccation in high airflow environments
• Environmental monitoring plates: key considerations
• Case study: Portsmouth Pharmaceutical Manufacturing Unit

Any environmental monitoring program must, by definition, demonstrate consistent capture of viable and non-viable particles in critical areas of your facility. Data processing must be reliable and results meaningfully shared.

Classifying your operation as aseptic can be complex. However, meeting the specific requirements of your area of industry with the right combination of equipment, protocol and validation processes can be tailored to your budget and business size - if you take a consultative approach.

The key is understanding your vulnerabilities, ensuring your teams are up to date with protocols and selecting equipment that can scale with your business.

• Maintaining a sterile cleanroom
• The cleanroom’s weakest link
• Lessons learned from NECC
• Key considerations when selecting active air samplers

Selecting the right air sampler for your business starts with understanding your specific environmental monitoring program and the data you need to collect to ensure compliance.

Key questions include: What sample size do you need? What type of sample should you be collecting? How many samples do you require and over what time period?

The importance of selecting the correct type of culture media can't be overstated. It must be reliable, available and fit for your specific purposes. False negative results can be just as damaging as false positives: you need media you can trust.

The kind of air samplers and accessories you select will depend on the type of areas you need to monitor and how your instruments should be positioned for the most consistent results. Finally, schedule regular calibration of your equipment to make certain the data you collect is always accurate.

• Cherwell Air Samplers Brochure
• Air Samplers for Cleanrooms
• Cherwell Air Sampler Calibration Services