Container Enclosure Integrity
USP <1207.2> Verified by <381>
The ability of a container to maintain sterility and not leak air must be proven. This test is based on the procedure for USP <1207.2> and verified by USP <381>. All testing is performed in duplicate, along with a control container to validate the procedure and verify that containers will leak if defective. Those containers that appear to have passed without leaking are then subjected to a spectrophotometric test to check for very small leakage that cannot be observed visually. Containers pass the test only if no leakage is found.