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
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
A. SUBSTANCES, OTHER THAN PARENTERAL PREPARATIONS IN GENERAL.
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 – Sterile Preparation:
FINISHED PREPARATION RELEASE CHECKS AND TESTS, in Physical Inspections, which states that “When 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.”
Also under Quality Assurance section, one of the practices include “Visual 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.”