Please can you provide a scientifically valid justification for the applicability of this test with regard to its use to validate sterile package integrity?
This test method has been used to determine the integrity of sterile medical device packages for close to 10 years. It is an FDA approved consensus standard, as it is included in the list of ‘approved standards’ in the FDA Guidance Document entitled “FDA Modernization Act of 1997: Guidance for the Recognition and Use of Consensus Standards; Availability”. This ASTM test method has been fully accepted in submissions by former FDA personnel (Ms. Cathy Nutter); who has actively participated in ISO and ASTM standards writing activities and has been an advisor to the CDRH on packaging related issues. Furthermore, the test method sensitivity has been established and the laboratory providing the testing can validate the method sensitivity prior to beginning a testing project. There is no guidance, regulation, specification, or other decrees by FDA or other regulatory bodies indicating what size hole must be detected in order to prove package sterile integrity.
