Asian Scientist (Jul. 6, 2016) – Since 1972, PMS’ contamination monitoring solutions have been helping laboratories and manufacturers across the globe to improve on their aseptic processes. As the largest particle counter manufacturer in the world, PMS sets the standard for contamination monitoring through highly-specialized products and services tailored to the client’s unique manufacturing needs.
A strong technical foundation, coupled with superior knowledge, technology, quality and service, positions PMS as the leader in particle measuring and contamination monitoring worldwide.
Superior knowledge
PMS is highly dedicated to hiring and training industry professionals. The company’s experts are recognized as thought leaders, evidenced through multiple speaking requests, webinars, authored papers and professional education levels.
Furthermore, the company’s core team of technology experts actively reaches out to its customers and participates in industry standards committees to understand the evolving needs and challenges faced by its broad customer base.
To help industry professionals further enhance their skills, PMS’ renowned Particle College® program offers a two-day series of lectures and hands-on labs. The program covers basic particle measuring concepts to advanced applications of contamination monitoring and control.
Superior technology & quality
The company’s core investments in research, engineering and product manufacturing have resulted in more than 60 patents related to various products and applications. Its technologies enable users to make fact-based decisions, improve process yield and comply with changing regulatory requirements.
PMS’ cutting-edge instruments can be used to measure particle sizes as small as 20 nanometers in water, ten nanometers in air, and molecular contamination concentrations in parts per trillion. Also an industry leader in microbial detection, PMS develops traditional techniques to reduce false positives and rapid techniques to improve the speed and accuracy of detection.
With a firm commitment to delivering quality products, PMS first designs reliability into its instruments and then backs the technology with an unmatched quality management system.
Superior service
PMS’ service technicians are well trained to calibrate instruments to the highest standards, supported by software that automates critical steps to drive consistency in each calibration. This ensures the same calibration results and performance, consistent with factory calibration, regardless of where the calibration is performed.
All calibrations are completed in strict accordance with ISO guidelines. PMS provides an unequalled counting efficiency test for first-channel sensitivity. For pharmaceutical applications, particle counters must be calibrated to the exacting standard of ISO 21501-4:2007, which includes measurements to verify and set flow rate, counting efficiency, particle sizing, resolution, signal ratios and zero count.
Each calibration is also completed using National Institute of Standards and Technology standards, and a certificate is provided with each calibration.
Revision of ISO 14644
Over the past five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and -2. On October 29, 2015, during the last voting session, the revised 14644-1 and -2 standards were approved by a significant majority of the member nations participating in the ISO/TC 209 committee.
The ISO community voted in favor of the revision to update and improve the standards specifically to:
- Simplify the classification process, and if possible, remove the need to evaluate the 95 percent upper confidence limit for low sample location numbers (currently required for two out of nine cleanroom locations).
- Review the classification procedure and make it more applicable to cleanroom operation. In this situation, the contamination is not expected to be evenly distributed; an assumption the current statistical approach makes.
- Generally, update the standard as required to current thinking and industry requirements.
- Avoid any radical change to the principles of the current ISO cleanliness classes 1÷9.
The same technical committee has also been working on the revision of the ISO 14644-2:2000 in conjunction with the revision of ISO 14644-1. The ISO community voted in favor of the revision to improve the ISO 14644-2:2000 standard to:
- Simplify and clarify requirement and guidance tables that specify frequency of testing and monitoring of cleanrooms used to demonstrate continued compliance with the cleanliness classification.
- Refine how these intervals may be extended, provided that automated monitoring systems show the cleanroom is under control.
- Provide new guidance on aspects that should be considered when configuring a monitoring system for a cleanroom.
The new changes described here will impact cleanroom classifications and any company that needs to comply with this standard will be required to update their internal SOP to meet the new ISO 14644 requirements. ISO 14644-1:2015 was published on November 1, 2015 and has been effective starting from January 1, 2016.
All users who want to be compliant with this standard will be required to take any necessary action before the end of 2016. All PMS instruments will be updated to fully meet these new ISO requirements.
Asian Scientist Magazine is a media partner of Particle Measuring Systems.
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Copyright: Particle Measuring Systems.
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