Defining the environment
ISO 14644-1 classifies air cleanliness by particle concentration. The environmental class alone does not establish the suitability of a mop or wipe.
Three different questions
Environmental class concerns air cleanliness; sterile status concerns the validated process and packaging; product suitability depends on evidence for the configuration under its task conditions.
Environmental class
Classification of airborne particle cleanliness.
Sterility
Scope of the validated process and packaging.
Product performance
Findings obtained with a specific sample, method and conditions.
A product's conditions are read in its own dossier.
Technical consultation
Define the area, surface, chemistry, use cycle and sterile supply requirements separately. Review the product dossier in this context.
Source
OWMO technical file; scope of ISO 14644-1.
ISO 14644-1