Digital Particle Classification and Qualification Method for ISO 14644 Compliant Cleanrooms
Particle classification is a central component of cleanroom qualification and certification according to ISO 14644-1. Particularly in the "at rest" state, it forms the basis for the formal cleanliness class classification and for recurring re-certifications.
The particle classification and qualification method in Moqlero automates this process and significantly reduces manual effort. Discontinuously collected particle measurements are evaluated according to standards and automatically consolidated into ISO class results based on configured acceptance limits. Measuring points, sample volumes, and evaluation criteria are consistently applied and reliably calculated.
Measuring devices from all common manufacturers are fully integrated into the workflow: they are automatically controlled, configured, and read out. Manual device settings, media breaks, or subsequent data transfers are completely eliminated. This enables a consistent "paperless maintenance" approach where measurement, evaluation, and documentation take place digitally within one system.
Classification results are immediately provided in automatically generated, audit-ready reports. Report generation complies with the requirements of 21 CFR Part 11 and ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, Credible). Approvals, versioning, and complete traceability are ensured by the system.
Moqlero establishes particle classification as a fully digital, reproducible, and regulatory-secure process that saves time and costs, ensures ISO 14644 compliance, and sustainably reduces organizational effort in cleanroom operations.