How to Maintain 21 CFR Part 11 Compliance with R100 Controllers
Microbial air sampling data supports product release decisions in pharmaceutical and biotech cleanrooms. When that data lives in electronic form, FDA 21 CFR Part 11 applies. The R100 Controller is built for remote sampling in critical ISO 5 zones and includes controls to help protect sample records. This guide explains what Part 11 requires and […]
ISO 14644-3 Test Methods: Airborne Particles, Flow, and Visualization Studies
Introduction: Proving Cleanrooms Perform as Designed Designing a cleanroom is one thing. Proving it performs according to ISO 14644-3 test methods is another. From airborne particle counting to airflow visualization studies, ISO 14644-3 ensures facilities meet their classification and regulatory expectations. Part 1: Core Test Categories Airborne Particle Counts: Calibrated using PSL standards. Airflow Visualization: […]
Cleanroom Classification Standards (ISO 14644): A Complete Guide
Introduction: Why Standards Define Cleanroom Success Without measurable standards, cleanrooms would be impossible to validate. The ISO 14644 series provides the global benchmark for cleanroom classification, defining how many particles of specific sizes are allowed in controlled environments. From semiconductor fabs to pharmaceutical sterile suites, understanding and applying ISO 14644 is essential for compliance and […]
