Application Note – Clean Room N.1 – Out of Specification (OOS) in Clean Room

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Out of Specification (OOS) in Clean Room

“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