Glossary Term
Cleanroom
Definition
A Cleanroom is a controlled environment designed to minimize contamination by airborne particles, microorganisms, and chemical vapors. It is commonly used in the MedTech industry for the manufacturing, assembly, and testing of medical devices and pharmaceuticals to ensure compliance with stringent cleanliness and sterility requirements.
Relevance to the MedTech Industry
Cleanrooms are critical for producing medical devices and components that must meet high sterility and quality standards. They provide a contamination-free environment, ensuring product safety, performance, and regulatory compliance, particularly for implantable devices, sterile packaging, and drug-device combinations.
Additional Information & Related Terms
ISO 14644 Governs standards for the design and operation of cleanrooms.
Good Manufacturing Practices (GMP) Includes guidelines for using cleanrooms in medical device and pharmaceutical production.
Sterility Assurance Level (SAL) Measures the effectiveness of cleanroom processes in achieving sterility.
Particle Count A key parameter monitored in cleanrooms to ensure air cleanliness levels.