Guide to Cleanroom Classifications
Who Sets Cleanroom Classifications?
Cleanroom classifications are typically set by regulatory agencies or industry standards organizations, depending on the sector and application of the cleanroom. The most commonly recognized classification systems include:
ISO (International Organization for Standardization): ISO 14644-1 is an international standard that defines the air cleanliness classes in terms of the number and size of particles per volume of air. This classification system is widely used in industries such as semiconductor manufacturing, pharmaceuticals, biotechnology, and medical devices.
FedStd-209E (U.S. Federal Standard): Although this standard has been officially replaced by ISO 14644-1, it's still referenced in some older facilities or documents. It classifies cleanrooms based on the number of particles per cubic foot at specific particle sizes.
GMP (Good Manufacturing Practices): In the pharmaceutical industry, the FDA (U.S. Food and Drug Administration) enforces GMP guidelines which indirectly influence the design and operation of cleanrooms to ensure product quality.
EU GMP classification: Refers to the classification of drug production quality management practices in the European Union. It mainly involves a series of standards and regulations in drug production and quality control to ensure the safety, effectiveness, and reliability of drugs. In the European Union, drug production and sales must comply with GMP (Good Manufacturing Practice) standards and be approved by the EU drug regulatory authorities. According to different types of drugs and levels of risk, the EU GMP standards classify drug production into different levels, namely Grade A, Grade B, Grade C and Grade D. Grade A is the highest level with the strictest requirements and requires approval from the EU drug regulatory agency before production can proceed. Grade B requires relatively lenient requirements, but still requires approval from EU drug regulatory agencies. Grade C is a general requirement, usually only requiring compliance with the basic requirements of EU GMP.
Other Industry-Specific Standards: There may be additional standards for cleanroom classifications depending on the industry. For instance, the aerospace industry might follow different standards than those set by ISO.
Ultimately, while these organizations set the standards, it's the responsibility of the facility owner or operator to ensure their cleanroom meets the appropriate classification for their specific processes and products. Cleanroom designers, contractors, and certifying bodies also play a critical role in achieving and maintaining these standards.
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