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Safety Standards for Cleanrooms

The use of cleanrooms is commonly required for manufacturers of sensitive electronic equipment, pharmaceuticals, sterile medical devices and in any other critical manufacturing environment where the contaminants present in outside air could destroy the product’s functionality. Though cleanrooms are critical parts of the manufacturing environments in which they are used, they are surprisingly unregulated by the U.S. government. In fact, the only federal standard that regulated cleanrooms was canceled in 2001, though manufacturers still widely use the standard as a guideline. It is important to keep in mind that the Food and Drug Administration (FDA) does have Quality Systems Regulations in place that require manufacturers to use structures that ensure their products meet provisions, and that the business follows good manufacturing practices; however, this does not specifically address cleanroom conditions. The International Organization for Standardization (ISO), of which the United States is a member, covers the classification of air purity in cleanrooms, and specifies the requirements for testing and monitoring cleanrooms to prove compliance. But from an employer’s perspective, it is not ISO 14644-1 and ISO 14644-2 standards that should determine how to treat your cleanroom facility; rather, it makes the most business sense for you to treat your cleanroom with the utmost care to ensure that the facility stays up to specifications. What Does Clean Mean? Individual subsets of industries set their own standards for just how “clean” companies’ cleanrooms must be. For example, integrated circuit manufacturers must operate in a cleanroom of no more than ISO 4, which does not allow any particles greater than 5 micro-meters in size, or one-thousandth of a millimeter. Depending on the type of manufacturing that is performed at your workplace, your ISO rating can vary. Check your industry cleanroom standards to determine the proper ISO rating. Standards aside, a cleanroom is only useful if it is maintained properly. Many employers are unaware of the fact that a particle 200 times smaller than the width of a human hair can cause a major contamination disaster in a cleanroom. Contamination will not only cost your company because of expensive downtime while the problem is fixed, but it will also result in increased product costs. For example, many electronic products produced in a contaminated cleanroom will not function properly and will result in product recall, while medical devices manufactured in a contaminated cleanroom will not meet FDA regulations. Preventing Contamination Building a cleanroom properly is the first step to saving money in the long run, since it is much easier to eliminate the possibility of contamination as the facility is being built. Removing contamination after the fact is not only extremely difficult, but also enormously costly in both time and money. It is important to warn your employees that contamination can come from many unexpected sources, including the following:

Ensuring that the facility meets the accurate air quality standards starts with requiring employees to wear the proper equipment while inside the cleanroom. Take Precautions To lower your cleanroom’s risk of contamination, take the following precautions: Check periodically for leakages in the shell enclosing the cleanroom that separates the clean air from the rest of the building. Remember that following these guidelines could save your company hundreds of thousands of dollars in lost product and in downtime by lessening your risk for cleanroom contamination.

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