by Richard A. Matthews
As part of our continuing coverage of the new ISO Global Cleanroom Standards, this month we look into ISO 14644-5 “Cleanroom Operations.” If you use or operate a cleanroom or plan to do so, you need to know what is in 14644-5.
TITLE: Cleanrooms and associated controlled environments – Part 5: Cleanroom Operations.
SCOPE: Specifies the basic requirements for operating a cleanroom.
This document covers all aspects of operating a cleanroom no matter what class of cleanliness or type of product produced therein. It is a referee document for smart cleanroom operation. Its title is concise while its 40-page content is all-inclusive.
It is impossible in this article to cover all the pertinent information in 14644-5. However, it is possible to hit some of the highlights.
There are six major areas of concern. The first is “Operational Systems,” where attention is focused on establishing a framework for providing quality products and processes in a cleanroom environment.
Covered are such factors as contamination risk assessment, training procedures, mechanical equipment operation and maintenance, safety and proper documentation to prove that appropriate procedures are in place and being followed. For example, what should you do if an out-of-control situation occurs?
The second major area is “Cleanroom Clothing.” Who wears what? How is it put on? When should it be replaced or laundered? What type of fabric is appropriate to your situation? We all recognize that the primary function of cleanroom clothing is to act as a barrier that protects products and processes from human contamination.
The degree of enclosing an individual is process and product dependent. It could be done by a simple lab coat or a totally enclosed body suit with a self-supporting breathing device. What choices should you make?
Decision guidelines are offered in this section.
The third major area is “Personnel.” Only properly trained personnel should be allowed to enter a cleanroom. To do otherwise is to create additional risk. Personal hygiene, cosmetics and jewelry can cause contamination problems. What is your policy in these areas? How should people enter and leave clean space? What is your personnel emergency response procedure? Personnel can have either a tremendous beneficial impact or a significant detrimental impact on your cleanroom operation. Your training and management will determine the impact you experience.
Fourth is the concern for the impact of “Stationary Equipment.” How clean should this equipment be before it is placed in a cleanroom? How should it be moved into this space and set in place? What kind of maintenance will be required? What types of ongoing support services will be needed? What will be the impact of these factors on control of contamination? Subjects such as these and many more are covered in this section of 14644-5, including control of contamination caused by the daily operation of this stationary equipment.
The fifth major area of concern covers “Portable Equipment and Materials,” i.e., items easily transported into and out of the cleanroom. What procedures are needed for control of these items in a cleanroom? Do some materials require protective storage and isolation? How is this done? How are waste materials collected, identified and removed from a cleanroom? Should there be a separate set of tools kept in the cleanroom? What items require sterilization? What items in the cleanroom have out-gassing properties? What items cause static? Because all consumable items in a cleanroom are potential contamination sources, what do you do to control them from entry through use to disposal?
The last area of concern is “Cleanroom Cleaning,” otherwise known as “Housekeeping.” Outlined are detailed cleaning methods and procedures along with personnel responsibilities. Here again, personnel training is important. How do you clean properly, how frequently and what contamination checks are required? Do you have an assessment system in place for evaluating your housekeeping? What special requirements are required, particularly in areas of risk due to hazardous material, hazardous equipment, equipment location, etc.? How aggressive are your cleaning compounds? How do you avoid adding contamination by your own cleaning procedures? Remember, a good cleaning crew can be just as valuable as a good production crew.
The questions posed above are just a few of the items covered by ISO 14644-5. While many of the existing Institute of Environmental Sciences & Technology (IEST)
Recommended Practices (RPs) are referenced in this Standard, 14644-5 is much more comprehensive than these IEST RPs for it incorporates cleanroom operation experience from all over the world.
Because it is impossible to cover all the important aspects of 14644-5 here, it is strongly recommended that you purchase your own copy and use it as a bible to intelligent cleanroom operation. It will save you operational headaches.
Copies of this document, ISO 14644-5 “Cleanroom Operations” may be obtained for a nominal fee from the Institute of Environmental Sciences & Technology, 940 East Northwest Highway, Mt. Prospect, IL 60056, Ph: 847-255-1561; Fax: 847-255-1699 or at iest.org.
The IEST is accepting orders now for fulfillment as soon as the ISO releases 14644-5 for its DIS vote, which is expected shortly.
Remember, a cleanroom is at its most pristine immediately upon completion of its construction. Everything that happens after that is the jurisdiction of ISO 14644-5.
Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC) and president of Micron Video International. He is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments,” and past president of the Institute of Environmental Sciences and Technology. He is on the CleanRooms Editorial Advisory Board.