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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
NEW INFORMATION GUIDES
Particle Counters
- ISO 21501 - Download our latest white paper on this recently released calibration procedure and verification method for airborne particle counters.
Microbial Air Samplers
- Biological Samplers - Download a short presentation on the regulatory guidelines, technology, and related ISO standards.
- FAQs - Review answers to the most frequently asked questions on microbiological monitoring in aseptic environments.
Molecular Monitors
- Molecular Monitoring - Download our presentation from Semicon Taiwan on the latest issues in molecular contamination.
Software
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DataAnalyst - This software package easily connects to your portable particle counter and allows for downloading, archiving and reporting that are fully compliant with all secure data transfer requirement.
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