• @AROUNDLAB | Quality, Safety and Hygiene for the Analytical Laboratory.

Application Note – Cleanroom N.01 – Out of Specification (OOS) in Cleanroom

1024 468 admin

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