Inspectors are increasingly scrutinizing calibration traceability, adherence to ISO 14644 revisions, and how well systems integrate with FDA 21 CFR Part 11 requirements. Older particle counters often fall short on secure data handling and audit trails, which can lead to issues. Upgrading ensures your monitoring program aligns with the latest expectations under FDA and EU GMP Annex 1.

Outdated particle counters don't just put you at risk for non-compliance; they can also mess with your data, giving you unreliable trends and inaccurate cleanroom release results. These problems often come to light during audits, with inadequate environmental monitoring tools frequently leading to 483s and warning letters. Replacing them promptly can help you avoid operational headaches and expensive fixes.

We use sectional testing methods and schedule work off-hours to minimize disruption. Replacement projects are coordinated with QA and operations to ensure continuity of environmental monitoring, reducing the risk of gaps in cleanroom qualification or product release schedules.