PERSONNEL PRACTICES AND PROCEDURES IN CLEANROOMS AND CONTROLLED ENVIRONMENTS
|Publication Date:||1 April 2006|
This Recommended Practice (RP) provides a basis for establishing personnel procedures and the development of training programs for cleanrooms and other contamination controlled environments.
BACKGROUND AND PURPOSE
Most cleanrooms need people to perform tasks associated with the operations being performed. Even fully automated operations require personnel to tend or service automated systems. People and their street clothing generate contamination, therefore an effective contamination control system should be adopted to minimize the risks to the product, process yields, or the cleanroom environment. Also, because activities within the cleanroom can carry in, generate, stir up, or transfer contamination from place to place within the cleanroom, a system of operational protocols should be developed, enforced, and monitored to maintain the proper controls. ISO 14644-5 identifies the basic requirements for addressing these operational issues. These normative requirements should be addressed to assure a minimally thorough operational cleanroom program.
This RP serves as a guide for developing a program to manage contamination caused by or associated with the people, processes, and tooling in the cleanroom. Contamination may be generated by the people or the activities they perform, or may be transported into the clean environment with the materials brought into it. Programs for the control of personnel-generated contamination are complex. In this document, the subjects often overlap. In some areas, there is deliberate redundancy between two sections. The reader will find the most specific and detailed information under the topic heading for a particular subject. However, related subject areas are included in the general discussions when these subject areas are pertinent to or have an effect on the main topic. References to sections of this document that provide more thorough coverage are included.
This RP provides a general description of the elements essential to a contamination control program as well as specific procedures for minimizing human-sourced contamination. The rationale behind the procedures and elements is discussed. The intent is to inform the user while assisting with the preparation of components of the program. This document specifies commonly accepted procedures and recommendations, and also points out considerations that should be made for a thorough and successful program.
Because there is a wide variety of degrees of cleanliness for cleanrooms (and differences in potential contaminants from which clean environments should protect products), some aspects of the procedures will be too stringent for some applications, while insufficient for others. A program should be expected to have a significant amount of individuality. What works well for one company or industry may not be acceptable in others because of factors such as local culture, facility constraints, large work forces, and government regulations.
The user is responsible for choosing the elements and degree of compliance that best suit the specific situation. In some cases, the advice of a contamination control consultant may be sought.
The science of contamination control is continuously evolving. Users are encouraged to find improved methods for controlling contamination appropriate for their needs and to share these with the contamination control community.
It is helpful to use data or experiments to evaluate whether a procedure is necessary or effective. Test methods are beyond the scope of this document.
It should be noted that there are several references available that provide a thorough background on contamination control theories, practices, and considerations. These references may be found in the text of this document and should be consulted when the user requires more detailed information.