Application Note – Cleanroom N.01
Out of Specification (OOS) in Cleanroom
“Investigation for “OOS” results
If there are significative variation in the trend, the following investigations are necessary:
- (a) Identification of isolated environmental micro-organisms
- (b) Revision of the trend during the last 6-12 months in the specific area
- (c) Particle monitoring
- (d) Monitoring and Servicing of the air conditioning or HVAC System
- (e) Sampling improvement
- (f) Revision of the sterilization processes
- (g) Revision of the cleaning and disinfection processes
- (h) Revision of staff training about cleaning, disinfection, sterilisation
Corrective actions in case of “OOS”
- (i) Environmental Sampling procedure revision
- (l) Re-environmental monitoring of the considered area
- (m) Use of other specific microbiological media
- (n) Revision of production procedures
- (o) Revision of cleaning and disinfection procedures
- (p) Challenge of isolates vs products
- (q) Challenge of isolates vs disinfectants
- (r) More appropriate staff training
- (s) Further controls on products