Federal 209E Standards

Prior to 2001, Federal 209E Standards were widely used to categorize cleanrooms into Classes 1-100,000. Although this system was replaced by ISO Classes 1-9, which encompass a broader range of classifications previously excluded by the old system, the FS209E nomenclature still exists in some industries as a familiar reference. See the chart above for the comparison between ISO classes and FS209E equivalents.

Other Cleanroom Standards

Some cleanroom applications must comply with special standards that are uniquely tailored to the threats facing their products and processes. Additional standards or industry requirements provide an extra level of protection, limiting allowed contaminants within controlled cleanroom spaces or specifying cleanroom layouts, safe operating practices, or cleaning procedures. These standards work to protect the products developed in cleanrooms and the people working to create them. A few examples of additional cleanroom standards are USP, ASTM and GMP.

USP Standards

US Pharmacopeia (USP) has a set of standards used to regulate cleanrooms developing, manufacturing, and packaging pharmaceutical products either for use in human or animal treatments. Most pharmaceutical cleanrooms must abide by USP 795, 797, or 800 standards. 

• USP 795: non-sterile pharmaceutical compounds
• USP 797: sterile non-hazardous compounds
• USP 800: sterile hazardous compounds

USP Standards exist to ensure product strength, quality, and purity so that all compounds are certified to be high quality, safe to use, and effective as a treatment or therapy.

ASTM International Standards

American Society for Testing and Materials International (ASTM) develops technical standards for many different industries from manufacturing to consumer product safety, some of which use cleanrooms to develop, test, manufacture, or package products. Three major cleanroom applications that subscribe to ASTM standards are automotive cleanrooms, aerospace cleanrooms, and plastics manufacturing cleanrooms.

ASTM standards are used to regulate a number of products, substances, and processes, including metal, rubber, construction materials, petroleum, textiles, solar technology, medical products and devices, nanotechnology, additive manufacturing, and industrial biotechnology, to name just a few examples.

GMP and CGMP Regulations

Good Manufacturing Practice, or GMP, regulations ensure product consistency and quality, specifically when applied to food, drugs, medical devices and products, and also blood. GMP covers topics from materials used in handling and production to employee training, facility requirements, and hygiene practices. The purpose of GMP regulations is to make sure all products are effective, pure, safe, and free of contamination. Products that are certified GMP promise high quality and safety throughout their lifetime.

GMP regulations are outlined by the US Food and Drug Administration and are backed by the power of FDA laws. They are particularly important in medical cleanrooms, including medical research, pharmaceutical cleanrooms, and medical device manufacturing, but also for food production and biosafe cleanrooms.

CGMP, or current Good Manufacturing Practices, refers to the current, up-to-date practices businesses must follow. GMP regulations are often revised and it is the responsibility of the business to make sure its facilities and staff are updated accordingly.