Particle Monitoring Method for Ongoing Cleanroom Operations according to ISO 14644
Structured particle monitoring is a central component of daily cleanroom operations and a prerequisite for sustainable compliance with cleanliness classes according to ISO 14644 and GMP specifications. Especially during ongoing operations ("in operation"), standardized and reproducible execution is crucial to obtain reliable and comparable measurement results.
The particle monitoring method in Moqlero supports standardized workflows for routine, discontinuous particle monitoring. It is suitable for comprehensive room monitoring as well as for targeted system and UAF checks on equipment and workplaces during operation. This allows critical zones to be continuously evaluated without disrupting existing processes.
Pre-configured sampling plans ensure that measurement parameters are defined in compliance with standards. Moqlero automatically controls, configures, and reads out measuring devices from all major manufacturers, minimizing operating errors and guaranteeing reproducible results.
This "Paperless Maintenance" approach replaces error-prone paper protocols with digital efficiency. Automatic report generation according to 21 CFR Part 11 and ALCOA++, along with simple handling, significantly saves time and costs in daily operations, while the captured data ensures immediate audit security.
As part of the Moqlero platform, the particle monitoring method combines standardized processes, ISO 14644-compliant execution, and audit-ready documentation – for efficient, safe, and rule-compliant cleanroom operations.