This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
This document specifies operational requirements that relate to:
— providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
— training of personnel;
— transferring, installing and maintaining stationary equipment;
— transferring material and portable equipment into and out of the cleanroom;
— maintaining a personnel management programme that includes a gowning programme;
— maintaining a cleaning programme that addresses special cleaning;
— maintaining a cleanroom maintenance programme;
— establishing an appropriate monitoring programme.
This document gives additional information in annexes for:
— personnel management;
— gowning;
— training;
— cleaning.
This document does not specifically address biocontamination control. For details on this topic, see ISO 14698-1 and ISO 14698-2.
This document does not apply to the following topics:
— aspects of health and safety management that have no direct bearing on contamination control;
— specific requirements for individual industries;
— specific requirements for equipment and materials used or associated with processes and products;
— design details of equipment;
— cleaning agent compatibility with cleanroom materials.
