In part 4 of our 5-part blog series on Annex 1 Quality Risk Management, we discuss cleanroom sampling points.
Definition of potential sampling points
Sample points include particle counters and microbial monitors.
- Identification of critical areas by HACCP analysis and process understanding
- Choose points within the critical areas according to defined criteria
- When performed this way, you can demonstrate a thorough evaluation based on scientific criteria that any sampling point was considered
Define final cleanroom sampling points based on available space, environmental design, evaluation of product and primary container closure exposure.
Contamination Control Advisory Team: Utilities
Our team can help you with your utilities sampling monitoring plan by doing a scientific analysis, through risk-based techniques, of Purified Water, Water for Injection, Pure Steam, and Gases systems for:
- Points of Use assessment
- Sampling frequency
- Sampling procedure
- Risk mitigation activities
Learn how our Advisory Services Team can help you identify cleanroom sampling points.
Instruments to consider are the Airnet or IsoAir 310P particle sensors, or the Lasair III particle counters. For microbial monitoring you can consider options such as the BioCapt Single Use microbial impactor.
In the next blog in this series we will continue to examine Annex 1 and Quality Risk Management principles and areas where those are discussed.
Want to read more? Jump to other released posts in this series:
- Part 1 of 5: Quality Risk Management- Principle Section 2
https://www.pmeasuring.com/blog/quality-risk-management-qrm-annex-1-section-2/
- Part 2 of 5: Quality Risk Management- Annex 1 section 6.1
https://www.pmeasuring.com/blog/quality-risk-management-in-annex-1-6-1/
https://www.pmeasuring.com/blog/viable-non-viable-particle-counts/
- Part 4 of 5: Definition of potential sampling points (you are here!)
- Part 5 of 5: Process Risk Assessment
https://www.pmeasuring.com/blog/cleanroom-process-risk-assessment-annex-1/
See links to additional supporting resources below:
- Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
- On-Demand Webinar: Case Study: Developing an Isolator Filling Line using a Quality Risk Management Approach
- Blog series: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
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/
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
https://www.pmeasuring.com/blog/cleanroom-process-risk-assessment-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
