Your Complete Source for ISO 14644-1:2015 Particle Counting Information

ISO 14644-1:2015 continues to pose challenges to cleanroom managers and manufacturers. Here we provide several sources of information to help everyone from those new to this ISO regulation to veterans in the field. 

Get a summary of ISO 14644-1:2015 by reading the paper below or watching the recorded webinar at the right. 

Read the papers below to learn about the closely relevant ISO 21501-4 calibration standards and how they apply to you. 

Have a question? Read some of the frequently asked questions we get (see the bottom right), or submit your own question for one of our experts. 

Do you need an ISO 14644-1:2015 compliant product that is supported with ISO 21501-4 calibration? If yes, see our list of products at the bottom. 

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Knowledge / Papers

ISO 14644-1:2015 Revisions Summary

ISO 14644-1:2015 Revisions Summary

The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

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Understanding ISO 21501-4 (EL)

Understanding ISO 21501-4 (EL)

ISO 21501 has the title Determination of particle size distribution—Single particle light interaction methods.

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Are your particle counters ISO 14644-1 compliant?

Are your particle counters ISO 14644-1 compliant?

Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?

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

 

Lasair® III Aerosol Particle Counter

Lasair® III Aerosol Particle Counter

The Lasair III Particle Counter is designed for cleanroom work with your unique needs in...

IsoAir® 310P Air Particle Sensor

IsoAir® 310P Air Particle Sensor

The IsoAir 310P Air Particle Sensor makes it easy to monitor aerosols in remote locations or in areas with process...

FacilityPro® Software

FacilityPro® Software

FacilityPro Software provides the interface, data management, and reporting for an environmental monitoring...

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PMS Provides Certified Compliant Service

Service Repair & Calibration

Service Repair & CalibrationAt Particle Measuring Systems we have strict processes and standards in place to ensure that we meet and exceed service and calibration standards such as:

  • ISO 21501-4:2007

ISO 9001:2008

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Recorded Webinar

ISO 14644-1: 2015

ISO 14644-1:2015 Revisions Summary

PRESENTER Daniele Pandolfi Global Product Specialist Aerosol, Life Science Division

Watch this on-dermand webinar and learn about ISO 14644-1:2015 and how it affects your clean anvironment monitoring

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Recorded Webinar

Personnel pose the greatest risk of false positives in aseptic processing. The BioCapt® Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate.

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Ask a Question

ISO 14644-1: 2015

Do you have an ISO 14644-1 question? Read our frequently asked questions below or submit your specific question and one of our experts will respond shortly. 

Frequently Asked Questions

Aerosol Particle Counter?

Can the Lasair II 550L be upgraded to be compliant with ISO 21501-4?

The Lasair II 550L cannot be upgraded to the new ISO certification requirements. This product has been obsolete since 2009 and it is recommended to upgrade to the fully compliant Lasair III. We can provide a quotation if you are interested in a new unit.

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How does the recent Lasair III firmware update work with the EU GMP classification for Grade A areas with the corrected ISO standard?

EU GMP Annex 1 provides specific particle concentration limits for specific cleanroom classes (Grade A, B, C and D). The Lasair III Aerosol Particle Counter, when used with GMP statistical mode, will refer to the GMP maximum concentration table.

To view all FAQs on this subject download the ISO14644-2 FAQ

Applications?

Does ISO 14644-1 apply to a solid dose facility?

Yes, ISO 14644-1 can be applied to this type of manufacturing area. You should verify which class and standard your cleanroom must be compliant with. ISO 14644-1 is applicable for any type of cleanroom, including Pharmaceuticals.

...

Has the new ISO had an effect on the number of the stationary particle counters (for monitoring) in a filling machine?

No, the number of continuous sample locations is not affected by the ISO14644-1. Monitoring control guidelines are available in the ISO14644-2 standards which clearly require a risk assessment based approach for the evaluation/selection of the sample location. Use this document for suggestions in selecting the best non-viable location for monitoring purposes.


To view all FAQs on this subject download the ISO14644-2 FAQ