scope:

This guideline describes requirements with respect to the operation of contamination control systems, which are specified within a quality management system to ensure compliance of the process environment with the pertinent cleanliness requirements. The requirements to be met by the controlled environment ("cleanroom process") and those to be met by the production process are often interdependent (see Section 4.3); it is recommended, therefore, to consider cleanroom processes as part of the production processes, where this may prove to be the case.

The scope of this guideline comprises all operating conditions that can be planned and foreseen. In addition to the cleanroom process and the production process, it covers normal operation, the "at-rest" condition, faults and their correction, and servicing and maintenance activities.

Exceptional conditions such as catastrophes and fires are not part of the scope.

Cleanroom operation, as defined in this guideline, starts as soon as the installation is ready planned, operative and cleared for operation.

The planning, installation and deinstallation of cleanroom systems, especially of small-scale or mobile systems, can also be carried out during cleanroom operation. This is only possible if the risk of contamination posed by bringing the system in question into, and installing and connecting it in, the cleanroom has been assessed as low by risk assessment; the acceptable level shall be defined by the user. The provision and qualification of consumables and clothing for cleanroom purposes are handled in the same manner. Special operating procedures for the transfer of these cleanroom materials into the cleanroom and for the disposal of the packaging materials used shall be established for both cases.

Where this guideline defines a general system for ensuring contamination control requirements during cleanroom operation, these definitions are normative in character. The entirety of pertinent recommendations represents the state of the art for the cleanroom system in question. Where particular activities are described, this is for information only, i.e. the user is required to select those measures which are indicated given the specific process requirements or regulatory requirements.