What are the requirements in terms of monitoring/testing for the release of sterile gowns to be used in a controlled environment (Grades A or B) when those are obtained from a supplier?

There is no specific requirements in the “Good Manufacturing Practices Guidelines, 2009 Edition (GUI0001)” for the sterility
testing of the protective garments to be worn in Grades A and B areas. However, the sterility cycle used by an
outside supplier to sterilize these garments should have been validated according to scientifically sound
procedures. Among other aspects, validation should address penetration/distribution studies of the sterilizing
medium (gas, radiation, heat, etc.), load patterns of the sterilizers, determination of the Sterility Assurance
Level with Bio indicators, etc. Also, the integrity of the outside wrapping in order to maintain sterility should
be demonstrated.