Glossary Term
Cleanroom Classification
Definition
Cleanroom Classification is the categorization of cleanrooms based on the allowable concentration of airborne particles of specific sizes per cubic meter of air. This classification ensures that cleanrooms meet the required cleanliness levels for specific manufacturing or research applications, such as those in the MedTech, pharmaceutical, and semiconductor industries.
Relevance to the MedTech Industry
Cleanroom Classification ensures that the environment is appropriately controlled to prevent contamination during the production of medical devices, sterile packaging, and other critical components. It supports regulatory compliance, product safety, and performance by establishing cleanliness standards tailored to the specific needs of the product being manufactured.
Additional Information & Related Terms
ISO 14644 The international standard for cleanroom classification and testing.
Sterility Assurance Level (SAL) Indicates the level of sterility achieved in cleanrooms and processes.
Particle Count A key parameter in determining cleanroom classification.
Good Manufacturing Practices (GMP) Encompasses cleanroom classifications for pharmaceutical and medical device production.