Viable and Non-Viable Environmental Monitoring to Meet USP 797
This paper simplifies and explains USP 797, highlighting what you need to know to meet the regulations, whether you are a 503A or a 503B. It also includes information on the most recent USP 797 updates.
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The innovative microbial air sampler. ISO 14698:2003 compliant
Robust and reliable cleanroom particle counter meets requirements for ISO 14644-1:2015, EU GMP Annex 1 and ISO 21501-4.
Most recent regulations are encouraging the use of continuous viable air monitoring in critical areas. The BioCapt Single-Use (BCSU) Cleanroom Microbial Monitor by Particle Measuring Systems (PMS) is an active sampling method that is superior to the usage of settle plates, that additionally creates validated and actionable data.
The BioCapt® Single-Use helps minimize microbial false positives in monitored clean areas by reducing contamination from the handling of agar settle plates, resulting in a decrease in investigations and an increase in productivity. Additionally, many costly and time-consuming sterilization steps, such as autoclaving, disinfecting, handling, and logistics are eliminated. This innovative approach to viable microbial air sampling and monitoring builds on the collection efficiencies of the BioCapt® stainless steel viable impactor, while also virtually eliminating false positives from handling through specialized packaging and single-use application.