If you work in the pharmaceutical, microelectronic, biotechnology, or semiconductor industries, then you know how important cleanroom management is. Not only is it crucial to make sure your employees are safe at all times, but the costs of failing to keep up with regulatory requirements can be exorbitant enough to severely damage or destroy your business. With such high stakes, it’s no wonder industry professionals take cleanroom classification so seriously. For your business to thrive, you need more than just the necessary documentation. Your cleanroom will have to be carefully constructed according to the latest codes and monitored at all times to ensure compliance. Since your cleanroom’s classification will have a determinative effect on how it’s regulated, here are some important things you should know.
Before You Start
The classification of your cleanroom starts with the application process. Given the broad differences in standards across several industries, you’ll want to make sure your cleanroom meets the legal requirements without going overboard. You’ll need to protect your employees and products from contamination, but you don’t want to pay for extra protection that’s not required.
The number of contaminants that are tolerable in a working cleanroom will determine the cleanroom’s classification. Using the International Standards Organization’s (ISO) standards, cleanrooms are classified on a scale of 1 through 9, with 1 being the cleanest. The classification is determined by both the number of the particles and the size of the particles. With sizes so small—as little as .1 micrometers (µm)—only sophisticated high-quality filters can detect them. If the cleanroom requires an ISO Class 1 classification, it can only have 10 particles of .1 µm, while an ISO Class 5 can have as many as 100,000 of the same sized particles. There are also standards for several other sizes of particles in order for a cleanroom to qualify for its required classification with sizes ranging from .1 µm to 5 µm and higher.
Federal Standard 209E
The ISO standard has been accepted internationally for the classification of cleanrooms
for years, but the United States didn’t adopt the standard until 2001. Prior to that year, the US relied on a classification known as Federal Standard 209E. While this standard has officially been cancelled, it can still be found in documents, and is sometimes preferred by people in the industry. Not only is the old system not accepted internationally, but it fails to account for ISO Classes 2 and 1. If you encounter Federal Standard 209E classes, be aware that it corresponds with ISO Class 3, and the FED STD 209E classifications increase by factors of 10, so that ISO Class 4 is the same as FED STD 209E Class 10, ISO Class 5 is equal to FED STD 209E Class 100, and so on.
While it may seem complicated (because it is), the important thing is to work with an organization such as Atlantic Technical Systems that understands your company’s needs and your cleanroom’s requirements. ATS understands both the documentation that’s required for compliance as well as the advanced technical issues that will ultimately impact your bottom line. If it’s time to install your own cleanroom, call Atlantic Technical Systems today!