A look at garment system considerations for cleanrooms and other controlled environments
By Mike Rataj, IEST member
The Institute of Environmental Sciences and Technology (IEST), through its working groups (WGs), develops recommended practices (RPs) that have long been recognized as effective and efficient tools for providing guidance to industry and academia on a variety of subjects. The WGs bring together the experience and expertise of end users and the vendor community with the goal of generating documents (RPs) that are of immense value. One of the best examples of this success has been in the area of cleanroom garments (WG-CC003). The current recommended practice, IEST-RP-CC003.3, Garment System Considerations for Cleanrooms and Other Controlled Environments, has become the source of information regarding garments and garment systems for the cleanroom. This RP is used regularly to specify garment configuration, fabric type, and processing requirements for garments used in every cleanroom application, and establishes practices and guidelines that are essential for the successful implementation of a garment program for any controlled environment.
Some of the recommendations made by the RP include:
■ Recommended gowning configurations for each ISO 14644 cleanroom classification.
■ Minimum acceptable standards for cleanroom garment construction.
■ Fabric recommendations for various applications and industries.
■ Cleaning and processing requirements for cleanroom garments.
■ Fabric performance and garment cleanliness testing.
The test methods and recommendations in the RP have been developed and validated to provide the most accurate assessment of the performance of cleanroom garments available today. These methods are widely used and accepted to evaluate everything from fabric and garment manufacturers to garment laundry services. The RP provides the essential how-to information an end user needs to make the best decision for his or her cleanroom program.
As an ANSI-accredited standards-developing organization, IEST policy requires the routine review and, where necessary, revision of its RPs. As a consequence, WG-CC003 is in the process of reviewing IEST-RP-CC003.3 for revision and update. To this end, WG-CC003 has initially decided to focus on two of the most difficult aspects related to cleanroom garment systems, such as size and fit standardization and thermoprotectivity or flame resistance.
Garment sizing is highly subjective. For example, a size medium garment from one manufacturer may be designated as a size small by another. This causes a great deal of confusion and additional cost for anyone trying to maintain a garment program. In order to address this concern, cleanroom managers are often required to purchase extra inventory to address variances in the fit of the garments they receive. Since the publication of the current RP in 2003, the committee has worked on developing a standard set of measurements and measurement values to ensure that anyone who is in the market for a cleanroom garment system will receive consistent sizing regardless of who the manufacturer is. Once sizing for the workforce has been established, the user can reliably purchase garments that will fit from a variety of manufacturers. The committee has developed a standard sizing table for the most common garments-coveralls, hoods, frocks, and boots. These garments will provide consistency in sizing from a variety of manufacturers.
The IEST working group has also recognized the need to provide guidelines and recommended practices for thermoprotective or flame-resistant garments. The Occupational Safety and Health Administration (OSHA) has established and is actively enforcing requirements to adequately provide personnel with protective equipment for all employees, including anyone who works on energized equipment. These employees are often called into cleanrooms during routine operations to troubleshoot equipment. Standard protective garments may not provide the level of contamination control required to work in the cleanroom. On the other hand, standard polyester cleanroom garment systems do not provide adequate thermal protection and, in fact, may actually add risk in certain situations.
Since the OSHA mandate, there has been a great deal of confusion as to which garments meet which risk category. The working group has voted to provide recommendations for garment systems that can provide adequate thermoprotection while maintaining the contamination-control integrity of the cleanroom. These recommendations will reflect the experience and knowledge of the members and will be tested to support the contributions submitted to the working group.
The members of the working group are anticipating the release of the updated document by the end of 2007.
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Mike Rataj, a member of the IEST, is the national quality assurance manager for ARAMARK Cleanroom Services, Inc. He has more than nine years of experience in the contamination-control industry and performs consulting and validation testing for various pharmaceutical and medical device companies. Prior to joining ARAMARK, Mr. Rataj worked in the microbiology field for eleven years in academia and industrial and pharmaceutical industries. He has a B.S. and an M.S. in biology from the University of Illinois-Urbana. His activities have included both R&D and production of pharmaceutical and animal health products.