In July, the Institute of Environmental Sciences and Technology announced that ISO 14644-9 "Cleanrooms and associated controlled environments—Part 9: Classification of surface cleanlinesss by particle contamination" is now a Final Draft International Standard (FDIS).
This revison of the document should make it more efficient and easy to understand for the user. It describes the classification of particle contamination levels on solid surfaces in cleanrooms and associated controlled environment applications and should build the new standard in this field.
Part 9 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations and it also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces.This part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 μm and 500 μm.
Surface cleanliness depends on material and design characteristics, stress loads (complexity of loads acting on a surface), and prevailing environmental conditions, along with other factors. Measurement methods of the classification should be adapted for surface characteristics (such as porosity, roughness, electrostatic charge, and surface energy). Recommendations on testing and measuring methods as well as information about surface characteristics are given in informative annexes.
It does not cover issues like
To get a complemented guidance, it is senseful to consider this document relating to ISO 14644 Part 1-8 (airborne contamination and chemical contamination) and ISO 14698 -1 and ISO 14698-2 (biological contamination).
For obtaining more Information or for ordering the document please see www.iest.org.
Please note that ECA's new Education Course "Contamination Control" in Prague, Czech Republic, from 9-11 November 2010 is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators.
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)