USP 797

USP 797 Environmental Monitoring Requirements

Learn how to meet USP <797> with proven solutions.

Our experts keep track of regulatory requirements and design effective solutions to make your processes compliant and efficient.


1. Start with this USP 797 overview paper

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.


2. Talk to Particle Measuring Systems’ USP 797 experts

Contact a USP 797 expert:

Our PMS experts can answer your USP 797 questions quickly by email, phone or chat (below). Let us know how we can help.

Watch the  webinar: Understanding and Applying USP 797  
Read the paper: Environmental Monitoring to meet USP 797


3. Easy to use solutions to help you quickly meet USP 797 503 A/B

MiniCapt Mobile BCSU
Microbial Air Sampler: MiniCapt® Mobile

The innovative microbial air sampler. ISO 14698:2003 compliant

Cleanroom Particle Counter: Lasair® Pro

Robust and reliable cleanroom particle counter meets requirements for ISO 14644-1:2015EU GMP Annex 1 and ISO 21501-4.

Airborne Particle Counter: Lasair® Pro
Traditional Air Sampling vs. BioCapt® Single-Use

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.

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Annex 1 2022 – Comparison to Previous Version

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