scope:

This technical report addresses routine monitoring for viable (i.e. microorganisms) and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized. As required by the current applicable quality system regulations, an appropriate environment must be established, maintained, and monitored for the manufacture of medical devices. The following types of viable and non-viable particulate monitoring are included in the scope of this technical report:

a) Air (viable and non-viable particulates)

b) Surfaces (viable particulates)

c) Water (viable particulates)

d) Compressed gasses (viable and non-viable particulates)

Personnel monitoring, product monitoring, differential pressures, and the effects of temperature and humidity on the manufacturing process are outside the scope of this technical report.

For requirements and guidance for establishing classified cleanrooms see ISO 14644.