Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 FAQ
This FAQ paper is a follow up to Particle Measuring Systems PMS webinar, Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for Annex 1 (now available on demand). Many thoughtful questions were asked concerning how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Particle Measuring Systems offers contamination control advisory services to help your clean area meet the requirements of regulations such as EU GMP Annex 1 and ISO 14644-1/2 as well as to assist with your contamination control strategy (CCS). If you have any additional queries for our experts, submit them directly here.
Topics in this paper include:
- Annex 1 Compliance
- Creating a cleanroom monitoring plan
- Solutions with Active Air Samplers and Cleanroom Media Plates
- Rapid Micro Methods
- Specific Applications
Complete the form to access the complete FAQ paper.
Learn more about a continuous viable monitoring solution for your cleanroom.
Learn more about the latest EU GMP Annex 1 draft rev 12 expectations.
Ready for a complete cleanroom monitoring solution?
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
Three Core Events to Establish Environmental Contamination Control – Per EU GMP 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
