All cleanrooms are the same, yet distinctly different. While each cleanroom is unique in terms of layout, design, or function, they each represent an investment on the part of the company designed to facilitate successful product manufacturing. In most cases, the investment to create a “controlled environment” is significant. But even with a substantial investment to create a suitable work environment, managing contamination within the cleanroom during daily operations is typically the greatest challenge. And what is the most unpredictable and uncontrolled variable in the cleanroom? The cleanroom worker.
Cleanroom workers represent one of the most challenging variables within these sophisticated environments. Even the cleanest person would represent potential for disaster if not properly isolated from the environment, which is why the apparel worn by workers is so critical.
Cleanroom glove and apparel manufacturers have many factors to consider. However, generally speaking, the needs of users come back to one common theme: the desire to minimize and control contamination, which comes in a variety of forms from biological to particulate matter or even nonvolatile and ionic residues on the surface of the glove. Whether designing gloves for a Class 10 “ultra-cleanroom” or a Class 10,000 “white-room,” the choice of glove becomes one of the more important steps toward success.
One goal, many variables
While all cleanrooms share certain characteristics, they also have different requirements depending on the industry. Cleanrooms in pharmaceutical manufacturing, for instance, must foster an aseptic environment free of bacteria or other micro-organisms. For the semiconductor industry, the level of cleanliness depends on what product is being made. The considerations are even more varied in a nuclear environment. In short, one large user base is going to operate different levels of controlled environments within its own facilities. The best glove manufacturers succeed because they are precise and adaptable with products suitable for the wide variety of applications.
This goal of minimal contamination creates a common set of variables that must be managed in regard to the cleaning, testing and overall care of the gloves, no matter in the industry or application. The gloves themselves are like referees in a basketball game: You know they did their job right if you didn’t notice them at all. Just like one bad call from the referee can change the outcome of the game, one contaminated glove can ruin thousands of dollars’ worth of potentially marketable product. For users like pharmaceutical companies, the stakes could be even higher.
The cleanroom glove manufacturers that provide the best quality take the time to follow certain best practices that ensure consistency, quality and glove cleanliness every time. And, more recently, even the overall worker experience in the form of comfort and efficiency has become a consideration.
Manufacturing, post-processing, and testing
As adaptable as they need to be, manufacturers must be consistent and vigilant in the way they manufacture, post-process, and test their gloves. Controlling the level of contaminants present on the surface of the glove is a constant challenge. High quality cleanroom gloves start with a well-manufactured base glove that then goes through several key post-processing steps, including hot water leaching and subsequent washing in Deionized (DI) water to remove potential contaminants as much as possible. In addition, packaging of gloves must be done in an appropriate cleanroom environment with non-shedding materials. Some manufacturers may choose to cut corners yielding inconsistent or questionable quality products. Whether it is to save money or increase efficiency, less reliable cleanroom glove manufacturers may choose not to conduct the vigorous cleaning needed to ensure the best product quality. Glove performance parameters are also benchmarked and tested in accordance with a variety of ASTM, IEST, and EN standards to make sure the products are meeting or exceeding industry norms.
Technology vs. reliability
Cleanroom apparel, including gloves, must adhere to many industry standards. But that doesn’t mean companies who meet these standards can rest on their laurels. The best manufacturers are constantly looking at ways to innovate, from sourcing better raw materials with unique performance characteristics, such as polyisoprene and polychloroprene, to designing products that not only protect the worker but enhance their overall experience in the workplace. This can be done by designing products that are more comfortable to wear; that carry actual, measurable ergonomic benefits to the wearer; and yet, do not sacrifice the protection and cleanliness needs of the cleanroom environment.
A cleanroom apparel maker that can’t reach the level of consistency needed on each and every glove they make can thwart the entire contamination control process employed in the cleanroom. Enterprises making decisions on cleanroom apparel can guard against this by choosing a trusted partner for these critical items. Another strategy is to make sure that any product is fully qualified for the specific application and cleanroom environment, whether it be aseptic or semiconductor manufacturing or something in between. This can help ensure that less reliable choices never make it into the cleanroom, where time and money can be lost.
Cleanroom glove nirvana
For cleanroom glove manufacturers that have proven best practices and have achieved a high level of consistency, the next exciting phase of innovation is happening right now. This area pertains to the level of comfort for the worker wearing the glove. The cleanroom, by design, is an uncomfortable place to work. Every cleanroom employee wears uncomfortable apparel that often restricts movement or agility. Anything that can be done to enhance the worker experience is a step in the right direction. It only stands to reason that making this experience better, more comfortable and safer also increases worker productivity.
The ideal cleanroom glove protects the worker and product adequately, but the person wearing it barely notices it is on. Easing worker discomfort and making everyone happier is the next phase in cleanroom apparel evolution. Leading manufacturers are investing heavily in research and development to achieve this end. For example, direct ergonomic benefit is evaluated by testing direct muscle effort in the hand and forearm while wearing gloves and performing tasks common to the industries these gloves are designed for. By scientifically showing a reduction in muscle effort with certain glove products, a direct comparison can be made to the overall comfort of the glove and provide the worker with a better overall experience.
Working toward the goal of better comfort, while maintaining the consistency in cleaning, testing, and product development that keeps the best cleanroom glove manufacturers on top is the next big challenge for the industry. Fortunately for users around the world, this goal is now within reach.
Don Cronk is the Regulatory Affairs & Technical Services Manager for Ansell’s Single Use Global Business Unit. www.ansell.com