A light scattering airborne particle counter determines the concentration of particles and is capable of counting and sizing single airborne particles and reporting size data in terms of the equivalent optical diameter.

The main sizes monitored are 0.5 µm and 5 µm and are reported as particles/m3 or particles/ft3; the ISO 14664-2 standard specifies a flow rate of 1 cfm for counter particles that are equal or larger than 5 µm. Lighthouse, Particle Measuring Systems, Beckman Coulter and Climet are just a few manufacturers of precision measurement particle counters.

ISO 14664-2 states that continuous environmental monitoring provides significant benefits with a detailed overview of cleanroom performance; alerts and alarms must be defined. The Rotronic monitoring system is a continuous environmental monitoring system that integrates all existing particles counters. The implementation of the Rotronic Monitoring System will help to achieve the ISO 14644-1. Continuous monitoring confirms consistent, high quality environmental conditions with any changes detected as soon as they happen.

The Rotronic Monitoring System Solution

The Rotronic continuous environmental monitoring system (RMS) is a GAMP©5 category 4 software combined with category 1 hardware, helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, focusing on patient safety, product quality and data integrity with compliance to EudraLex Annex 11 and FDA 21 CFR Part 11. RMS is a modular system, particle counters from several manufacturers can be integrated easily enabling measurements to be available on demand for authorised users, on any device, with alerts and alarms configured.

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