Environmental monitoring programme established
Ergopharm has established a formal environmental monitoring programme for its classified areas, with sample locations chosen from a written risk assessment rather than from where it is easy to place a plate.
Environmental monitoring answers one question: is the contamination control working where it matters? That makes location selection the whole exercise. A programme that samples convenient corners will produce reassuring data and detect nothing, while one that samples the points closest to exposed product will occasionally produce uncomfortable data — which is the point.
“A monitoring plan that never finds anything was probably designed to find nothing.”
The programme covers non-viable particle counts, viable air sampling, settle plates, and surface and personnel contact plates, at frequencies set by the classification of the area and the activity in it. Alert and action levels are derived from the site's own qualification data, so that a level is exceeded when this facility is behaving unusually, not when it fails a generic threshold.
Results are trended rather than only compared to limits, because a run of results drifting upward inside the limits is the signal worth having.
Key facts
- Locations
- Selected by written risk assessment, near exposed product
- Covers
- Non-viable particles, viable air, settle, surface, personnel
- Levels
- Alert and action derived from the site's own data
- Analysis
- Trended, not only compared against limits