The Pharmaceutical Cleanroom
Today's Reusable Garments Offer Advantages
by David Hobson
Among the many challenges of producing sterile fill pharmaceutical products is the need to provide workers in the protected environment with cleanroom garments that arrive on time, meet sterility requirements of the production process and function as expected during wear.
Beyond the basics, additional needs come into play. Top management, of course, wants the cleanroom garment systems to be as cost-effective as possible. Employees would like garments that allow flexibility of movement while performing their tasks, and air permeability to help prevent workers from becoming too warm.
The need to monitor garment system vendors and evaluate new vendor contracts adds to the already big job of managing cleanroom garment systems. Pharmaceutical cleanroom operators frequently choose disposable cleanroom wear, in some cases believing that it will be simpler to manage.
Today's reusable products and laundry services, however, offer an attractive option worthy of consideration for many pharmaceutical cleanroom operations. And making sense of reusable system options and services is easier than ever.
Uniform service providers that offer cleanroom garment processing provide assistance to customers that goes beyond simply providing apparel, picking up dirty garments, laundering them, and delivering clean ones. When these companies consult with clients, they work to make sure that all choices best meet customer needs and requirements specific to the industry and to the production process located in the controlled environment.
The Uniform and Textile Service Association (UTSA) is an international trade organization that represents these companies and works to convey information about new uniform textile options.
Cleanroom Garment Processing: Attire for the Protected EnvironmentThere are four primary objectives that cleanroom garment systems generally must meet:
Garments must form a particulate barrier, to help prevent contaminants carried by workers from entering the controlled environment and making contact with equipment or product. Potential contaminants may be biological or chemical. Of particular concern are bacteria, lint and the millions of skin flakes that the human body sheds daily;
Garments must permit the body to breathe while allowing the cleanroom worker flexibility to move as needed to perform all required tasks;
The garment system must meet site-specific requirements of the product or process, such as static dissipation at microelectronic production sites;
The garment must not itself contribute to particulate contamination.
Reusable garment processing requires advanced technology and must include several steps:
Delivery of soiled garments and inspection at the processing site. Inspectors sort garments for specific processing based on requirements of the controlled environment in which the garments are worn;
Laundering in a pass-through washer designed to help ensure compliance with regulations. A pass-through system permits soiled linens to enter through one side and come out the other after cleaning, with lower air pressure on the soiled side ensuring that microorganisms do not flow through and contaminate clean garments. Water used in the wash process is treated using methods such as ultra-filtration, reverse osmosis or radiation to kill bacteria;
Drying of garments in a pass-through dryer with HEPA filtration;
Folding and packaging. The drying process brings garments to a packaging room that, like the entire process, should be ISO-certified to ensure that cleaned garments are not contaminated. Workers attired in cleanroom wear fold garments and seal them in packages;
Sterilization. Gamma or electron beam radiation are often used to sterilize packaged garments to the desired sterilization level for the manufacturing process in which they are used;
Quality assurance testing. Test garments and garment systems are selected for a process of testing procedures designed to check garments against customer requirements for sterility.
Garment processing facilities may be ISO-certified at varying class levels to reflect thenumber of particles of a particular size in a cube of air at any moment. The ISO (International Organization for Standardization) is a private worldwide organization setting management and environmental standards for regulatory requirements.
Reusable Cleanroom Garment FabricsWorking closely with a cleanroom garment processor to select the best garment system and evaluate its test results against your manufacturing requirements will help ensure consistent performance on the job. Cleanroom garment processing companies provide their customers with a variety of information on currently available garment system options.
Polyester has traditionally been considered the most practical fabric for reusable cleanroom wear because of its non-lint generating filaments. Sterilization and gamma processing will degrade polyester fabrics, but manufacturers work continually to improve the technology and yarns used in the weave, so as to prolong garment life.
The ideal fabric weave, static dissipative capability and finish will vary from one situation to another. Clearly communicating the requirements of your production process will help ensure that a cleanroom garment processor recommends reusable garment fabrics that will provide the desired protection.
Today's options include anti-microbial finishes that can enhance the fabric's capability of preventing release of bioactive particles from the worker into the sterile environment, and preventing environmental contaminants from making contact with the worker's skin. In addition, various technologies can be used to eliminate static charges, in some cases without using wrist straps or heel grounders.
Testing methods can help ensure that reusable cleanroom garment fabrics will stand up to the demands of a given production process. Will the garment system ensure a consistent particulate barrier? Will it be durable enough to withstand the normal stress resulting from worker movement - on its first use and for multiple additional uses, given that sterile processing will eventually degrade the fabric? Is the fabric sufficiently non-lint-generating during normal wear with typical levels of movement?
A variety of validating methods can be used by cleanroom garment processors to assess garment systems in all of the above categories. When considering whether a specific vendor will offer adequate testing, a thorough review of the testing methods and the data they are capable of producing is necessary. Testing costs also should be spelled out in detail in the vendor contract.
In addition to review of all garment system testing and quality assurance methods, keep in mind that nothing can replace a site tour and audit of the contractor's facility by a representative of your company, to view processes first-hand.
Traceability of individual garments and lots must be assured via a strong garment tracking system using either chips or bar coding. A strong tracking system ensures that when the garment reaches the end of its usable life, based on testing data, it will be removed from use permanently.
Changing to Reusable Cleanroom Garments: Factors to ConsiderConsumable (disposable) cleanroom wear is worn once, then disposed of in a landfill or via incineration, vs. up to several dozen uses of a reusable garment. Even though processing requires water and electricity, with reusable garments the difference in terms of how an organization impacts the environment is substantial, especially if cleanroom wear is used daily.
There also may be strong financial incentives to consider reusable cleanroom garments. Even a small plant may spend thousands of dollars per month for incineration of used disposable cleanroom wear. Add to that expense internal and product costs incurred prior to disposal: Purchasing of garment systems, shipping garments to the plant and distributing the appropriate garments to the correct sites internally.
For companies using cleanroom wear on a daily basis, a survey by a cleanroom garment processing firm showed that changing from disposables to reusable garment systems could reduce costs by nearly 30 percent.
Of course, each situation is different and reusables may not always be the best option. For example, in a research and development setting, cleanroom wear may be used just once a month or less. Until work requirements or production increase, such a company may find consumables more practical and cost-effective.
Also, ask about product combinations that may be assembled under a rental contract to enhance the cost-effectiveness and value improvement capabilities of a cleanroom system. Think beyond basics like coveralls and booties or calf-high boots. Reusable, sterile-processed hoods, for example, may replace disposable face masks.
In settings where U.S. Food and Drug Administration standards recommend goggles, reusable goggles can be processed and validated up to a sterility assurance level (SAL) of 10¯6. And the processed goggles cost considerably less per use than the typical $4 to $5 per pair of sterile disposable goggles.
Want to know more about reusable cleanroom garment processing? Visit www. uniforminfo.com to learn more.
About the author: David Hobson is president of the Uniform & Textile Service Association. He can be reached at firstname.lastname@example.org. The association would like to thank Prudential Overall Supply for contributing information to this article.