Glossary Term
Bubble Leak Testing
Definition
Bubble Leak Testing is a non-destructive testing method used to identify leaks in medical device packaging or sealed components by submerging the item in water or a liquid bath and applying internal air pressure. The presence of bubbles indicates a leak, providing a visual and straightforward way to assess packaging or device integrity.
Relevance to the MedTech Industry
Bubble Leak Testing ensures the integrity of medical device packaging and sterile barriers, which is critical for maintaining sterility, safety, and functionality. This method is commonly employed during manufacturing and quality assurance processes to detect defects that could compromise product performance or patient safety.
Additional Information & Related Terms
ISO 11607 Specifies requirements for packaging of terminally sterilized medical devices, including leak testing.
Sterility Assurance Level (SAL) Ensures the packaging remains intact to maintain sterility.
Package Integrity Testing Bubble Leak Testing is one of several methods to evaluate packaging integrity.
Non-Destructive Testing (NDT) Includes methods like Bubble Leak Testing to assess device or packaging without causing damage.