SOP for Handling of Leak Test Apparatus

The SOP for Handling of Leak Test Apparatus explains the standard method for checking the seal integrity of pharmaceutical packs such as strips, blisters, sachets, and bottles. Its main purpose is to ensure that packed products are properly sealed and protected from moisture, air, and contamination. The procedure describes sample collection, test frequency, equipment operation, vacuum settings, hold time, observation, and acceptance criteria. During testing, samples are placed under vacuum in water and then checked for any sign of leakage, wetness, or stickiness. If leakage is found, the concerned Production and Quality Assurance teams are informed, affected packs are checked, and necessary corrective action is taken before packing continues. The SOP also covers cleaning of the apparatus, recording results in the logbook and batch packing record, reconciliation of tested samples, destruction of non-recoverable samples, and responsibilities of operators and QA personnel to ensure consistent and reliable leak testing every time.
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