USP 797 – Sterile Preparations

Meet USP 797 viable and non-viable monitoring requirements.

3 Easy Steps to Effective USP 797 Monitoring:

 

1. Start with this USP 797 overview paper

This paper, Viable and Non-Viable Environmental Monitoring to Meet USP 797, 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 the 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. Let us know how we can help.

 

3. Find the right solution for you:

Easy-to-use solutions to help you quickly meet USP 797 503 A/B
Microbial Air Sampler: MiniCapt® Mobile

Innovative, light, and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data. Annex 1 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.

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located.
Contact us today for a quote

 

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 use of settle plates and 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; thereby, 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.

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Contamination Control Products

Portable Particle Counter: Lasair® Pro

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Active Air Microbial Sampler: MiniCapt® Mobile

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Continuous Microbial Monitor:
BioCapt® Single-Use Impactor

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Or, let us help you find a solution for your contamination monitoring:

Still have Questions?

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