Cleanroom classification restated to ISO 14644-1:2015
Ergopharm has restated its cleanroom classification against ISO 14644-1:2015, adopting the revised standard's sampling-location and statistical approach at the next scheduled requalification.
The 2015 revision changed how many sampling locations a room requires and how the results are evaluated, replacing the earlier approach with one based on the room's area and a defined confidence treatment. For a facility already classified under the previous edition, the practical effect is more sampling points in larger rooms and a more explicit statistical basis for the conclusion.
“Classification tells you what the room can be. Monitoring tells you what it was while you worked in it.”
Requalification was performed at rest and in operation for each classified area, alongside recovery testing and airflow visualisation. Results were folded into the environmental monitoring programme, which uses classification as its baseline but monitors continuously against separate action limits.
The classification standard and the GMP monitoring expectations are kept distinct in the site's documentation — a distinction that later mattered again under the 2022 revision of EU GMP Annex 1.
Key facts
- Standard
- ISO 14644-1:2015
- Changed
- Sampling locations by area; statistical evaluation
- Performed
- At rest and in operation, with recovery testing
- Kept distinct
- Classification vs routine monitoring limits
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.