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