The current USP requirements for particle monitoring can be summarized as ‘to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications.’ Therefore, laminar flow hoods used in the manipulation of sterile product should meet ISO 5 limits. Background areas and ante rooms should meet either ISO 7 or ISO 8, depending on the activities performed in those areas.

To ensure that the designated zone is maintained in a clean state, a particle monitoring program should be designed based upon contamination risk to finished product quality. The ISO 14644-2 standard is referenced and is the recertification schedule for proving continued compliance. However, this is not a monitoring program. The Parenteral Drug Association (PDA) offers guidance pertaining to monitoring frequency which is based upon risk in manufacturing environments and is in accord with FDA requirements. 

Knowledge / Papers

USP 797 Summary and Solutions

This easy to read paper summarizes and highlights ISO 14644 and USP 797 definitions and requirements and then continues on to demonstrate how you can meet USP 797 requirements to be compliant. 

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ISO 14644-1:2015 Compliant Products
Supported by ISO 21501-4 Certified Calibration

 

HandiLaz Mini hand held Particle Counter

HandiLaz Mini hand held Particle Counter

Easy-to-use USP 797 solution; ergonomically designed with pharmacists in mind,.

Lasair® III Airborne Portable Particle Counter

Lasair® III Airborne Portable Particle Counter

Sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

BioCapt® Single-Use Microbial Impactor

BioCapt® Single-Use Microbial Impactor

This innovative approach provides 24 hr sampling, and minimizes false positives, resulting in a decrease in investigations.

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Particle Monitoring to Meet USP <797>

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