More Information

GMP and cGMP Particle Counting Requirements for EU and FDA Regulations

What is GMP?

GMP stands for "Good Manufacturing Practices" as directed and regulated by FDA and EU agencies.

Learn about viable and non-viable particle monitoring for GMP and cGMP FDA and EU compliance from the papers listed. Find GMP monitoring solutions from the products listed below.

Contact us if you need more information or have questions regarding GMP monitoring.

Papers

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Technical Review: Particle Counting to Meet European GMP Annex 1, 2008 edition (709.0 KB)

Read this technical summary of the updated particle monitoring recommendations in the 2008 EU GMP Annex 1. This paper discusses why the new Annex was needed, and how to comply.

Download above file for full tables and figures, or for overview, see HTML Version.

Particle Counters for Cleanroom Monitoring and Certification (381.5 KB)

This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to certify a cleanroom. Special examples of a sterilizing tunnel and lyophilizer are included. Learn more now...

Download above file for full tables and figures, or for overview, see HTML Version.

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EU GMP 5 µm Particle Counter Limits Advice (860.1 KB)

There is a common industry misconception that 1m3 particle monitoring should be performed...(download file to continue to learn more)

Download above file for full tables and figures, or for overview, see HTML Version.

Products

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Lasair® III Particle Counter

The Lasair® III particle counter is ISO 21501 compliant through the use of an on-board PHA. Its large IR touch screen with simplified user interface makes the new standard for particle counters.

Model

310 C
350 L
5100

First Channel

0.3 µm
0.3 µm
0.5 µm

Flow Rate

1 CFM
50 LPM
100 LPM

Airnet® Particle Sensor

Easy and cost-effective particle counter to simultaneously monitor particles from multiple locations.

Model

201
301/OPC
501/OPC
310
510/XR/OPC

First Channel

0.2 µm
0.3 µm
0.5 µm
0.3 µm
0.5 µm

Flow Rate

0.1 CFM
0.1 CFM
0.1 CFM
1.0 CFM
1.0 CFM

Services

Particle Counter Rental / Leasing Options

If you need a particle counter or molecular contamination monitor for a short-term project or troubleshooting, we offer a comprehensive rental program.

Pharmaceutical Microcontamination Monitoring Services

We have managed over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices.

Without Measurement There Is No Control

Information on this website is subject to change without notice.