Leakage Test for packaging

Dear All
could let me know that how can i find regulation and guideline for leake test and its criteria (it ups to the type of packaging material (ALu-alu, Alu-PVC)?

i would like to write my SOP for Leakge test but i dont know the acceptance criteria :frowning:

thx for your helps

I do not have answer for previous post, but I have additional question:
Leakage test should be performed to entire batch or just a random sample of each batch (especially for parenteral)? Please give me the link of the related guidance document. Thanks in advance.

[b]In [SCHEDULE U(See rules 74, 74A, 74-B, 78 and 78A)

I. Particulars to be shown in Manufacturing Records


Its clearely mentioned to perform leak tests.[/b]
They should be performed at regular intervals. These should be collected from Strip/Blister/Alu-Alu machines atlesat 30-45 minutes once.
Collection of atleast 2 or 3 strips is a good prcatice.

After the test look for the wetness inside the strip or if you use a dye look for the sepage of the dye that is visible thru the packing.

Clean the strips with a dry cloth completely after the test and look for leaks.


Following statements are mentioned in USP <797> Pharmaceutical Compounding โ€“ Sterile Preparation:

FINISHED PREPARATION RELEASE CHECKS AND TESTS, in Physical Inspections, which states that โ€œWhen CSPs are not distributed promptly after preparation, a predistribution inspection is conducted to ensure that a CSP with defects, such as precipitation, cloudiness, and leakage, which may develop between the time of release and the time of distribution, is not released.โ€

Also under Quality Assurance section, one of the practices include โ€œVisual inspection of CSPs to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling.โ€