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

Modern Trends in Non‐Viable Particle Monitoring during Aseptic Processing This paper describes changes and improvements to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which is a regulatory requirement during aseptic processing. Aseptic processing is becoming more automated and increasingly important to future products of the biopharmaceutical industry. In the same manner, NVP monitoring is also becoming more automated and increasingly important for contamination risk management during aseptic processing.
Changes to GMP Force Cleanroom Re-Classifications This paper explains the rules of ISO 14644-1:2015, which has substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
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.
Quality Control Electronic Records for 21 CFR part 11 Compliance This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
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.