Environmental Monitoring

MET ONE 3400+

Allows GMP cleanroom users to simplify their routine environmental monitoring and improve data integrity.

Facility Monitoring Systems (FMS)

 Scalable on-line particle monitoring solutions based on open architecture communications that integrate easily and enables EU GMP Annex 1, FDA and your internal quality system compliance. 

MET ONE 6000

 On-line air particle counter with 0.3/0.5 μm sensitivity designed for ISO 21501 compliance

MET ONE HHPC+ Series Handheld Particle Counters

 The MET ONE HHPC+ series of handheld particle counters is light weight for checking ISO Class 5 validation (FED STED Class 100) or higher cleanrooms and controlled environments. It has a large screen and easy data download via a USB cable, memory stick or ethernet connection. 

Helpful Links

Content and Resources

Vaporized Hydrogen Peroxide Decontamination of Vi–CELL BLU Instrument This application note demonstrates the method and results for testing the Vi-CELL BLU for VHP resistance.
Classifying a Small Cleanroom using the MET ONE HHPC 6+ This applications note will demonstrate the classification of a small ISO Class 5 Clean room and associated ISO Class 7 gowning room using a MET ONE model HHPC 6+ handheld particle counter. Reference will be made to the ISO 14644-1 clean room classification standard with regards to sample size, locations selected, limits and calculations necessary to determine the compliance status of the clean zone to ISO 14644-1 Class 5.
Cleanroom Routine Environmental Monitoring – FDA Guidance on 21 CFR Part 11 Data Integrity This paper examines the risk of error with SOPs being implemented manually. Technology exists and is commercial available to mitigate this problem and make programs more robust, reducing the impact on data integrity and also supporting the industry's move towards environmental monitoring by production staff in the cleanroom.
Conducting the ISO 14644-3 Cleanroom Recovery Test with the MET ONE 3400+ This application note reviews the test method and provides guidance on selecting both the “Challenge” and the “Target Cleanliness Limit”. Attention is given to the requirement that the test concentration should not be so high that “residue contamination” becomes a risk.