REVISED ISO Cleanroom Standards for Contamination Control

ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. Founded in 1947, ISO has published more than 20,500 International Standards covering almost all aspects of technology and business.

ISO Cleanroom Environmental Monitoring
Cleanroom Environmental Monitoring

ISO has a number of standards related to cleanrooms. It has revised the first two of these to take into account the latest technological developments . These are:

ISO 14644-1:2015, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2:2015, Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms.

Contract Laboratory has helped many manufacturers with the outsourcing of testing related to cleanroom standards and controlled environments including environmental monitoring and particle testing. Below are some examples:

  • Scotland Microbiology Laboratory needed for Viable count, re Grade C cleanroom launch in accordance to GLP, ISO,UKAS
  • North American FDA, GMP, GLP Microbiology Laboratory needed for Cleanroom type testing of PE and Vinyl glove as per following: 1.Total Aerobic count to IEST-RP-CC005-2 2.Total recoverable anaerobic spores to IEST-RP-CC
  • Microbiology laboratory needed for cosmetic testing:stability, packaging, manufacturing cleanroom, preservative, outset–microbe test.
  • FDA GMP laboratory needed for environmental monitoring testing as per recent USP <797> Guidelines for environmental particulate count monitoring, need assessment of current product line packaging Guidelines Dynamic

If your company needs a laboratory for cleanroom standards testing or environmental monitoring, Submit Laboratory Test Request

If your company has questions about cleanroom standards testing, please give us a call at 1-855-377-6821.