Qualifying Your Particle Counter for EU GMP Annex 1 (2022)

What Annex 1 (2022) expects

• Continuous total particle monitoring in Grade A for the full duration of critical processing, and frequent monitoring in Grade B.
• Particle sizes of ≥0.5 µm and ≥5 µm, with alert and action limits set from qualification data.
• A contamination control strategy (CCS) that justifies sampling locations.
• Openness to rapid and alternative microbiological methods, such as real-time viable counters.

Selecting the instruments

Use a portable counter (TSI AeroTrak+ A100) for ISO 14644-1:2015 classification and periodic monitoring, remote counters (AeroTrak+ 7510, with the VHP version for isolators) for continuous Grade A, and consider BioTrak for real-time viable data. Details are on our particle counter page.

Qualification checklist

1. URS: flow rate, channels, data integrity, integration with the FMS.
2. IQ: installation, calibration certificate (ISO 21501-4), software versions.
3. OQ: zero count, flow verification, alarms, data transfer to the FMS, audit trail.
4. PQ: in-situ runs at operational state, tube-length verification (keep tubing short; 5 µm particle loss rises sharply with long tubing).
5. Ongoing: annual calibration, periodic review of alarm trends.