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- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
- 21 CFR Part 11 Compliance
- Airborne Particle Counters
- DI Water / UPW Particle Monitoring
- GAMP® Requirements and Solutions
- GMP and cGMP Particle Counting Requirements for EU and FDA Regulations
- ISO 14644 Cleanroom Classes for Particle Monitoring
- ISO 21501: Determination of Particle Size Distribution
single particle light interaction methods - ISO Cleanroom Class Particle Monitoring
- ITRS Roadmap Solutions
- Microbial
- Monitoring Particles in Injectables for USP 788 and EP6
- NEW INFORMATION GUIDES
- NEW INFORMATION GUIDES
- Optical Haze Blurs the Bottom Line
- Particle Counters for Gas Applications
- USP 797 Particle Monitoring Solutions
- WET PROCESS CONTROL
- processcontrols
ISO 14644 Cleanroom Classes for Particle Monitoring
ISO 14644 cleanroom classification is now the accepted world wide standard for classifying the cleanliness of the air in cleanrooms and clean zones. ISO 14644 replaced Federal Standard 209E (FED-STD-209E).
Learn about ISO 14644 by reading our papers below, see the following products to help you meet cleanroom monitoring standards, or review submitted questions. Please send us your ISO 14644 questions.
Papers
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When considering the purchase of a particle counter, the user typically considers factors such as price, quality, laser lifetime, warranty, and service. This paper discusses the performance-related factors of the particle counter which also must be considered if... Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (Glossary of Common Terms used in Particle Counting) This paper covers definitions of the most common terms used in particle counting, including "Differential Counts," "Counting Efficiency," and "Normalized Counts." A clear understanding of these terms will help you better understand your particle counter data and... Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (Selecting an Airborne Particle Counter) Understanding which features you need in a particle counter is a difficult task. This article will identify the various features available and help you choose those that are relevant to your application... Download above file for full tables and figures, or for overview, see HTML Version. |
Products
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Lasair® III Particle CounterThe 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. |
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Lasair® II 110 Particle CounterThe Lasair II 110 particle counter has a full set of features, unequalled accuracy, reduced |
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Airnet® Particle SensorEasy and cost-effective particle counter to simultaneously monitor particles from multiple locations. |
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Services
Particle Counter Rental / Leasing OptionsIf you need a particle counter or molecular contamination monitor for a short-term project or troubleshooting, we offer a comprehensive rental program. |
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Pharmaceutical Microcontamination Monitoring ServicesWe have managed over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices. |
FAQ's
- How do Airnet 510 particle sensors (1 cfm) comply to ISO 14644-1 standard for Class 5 (29 counts per cubic meter @ 5.0 micron)? Currently, we've worked out all sampling intervals to be 25 minutes, in order to achieve 690 Litres of sample air based on the ISO 14644-1 standard for Class 5.
- We are setting up a manufacturing facility which will have areas specified with particle concentaration limits as per ISO 8. The system is ready for validation. Which guidelines should be followed before starting the particle count tests.
Information on this website is subject to change without notice.
