T/SHBX 012-2024 Pour-through test method for pharmaceutical disposable process bags - Pressure decay method

Scope

1.1 This document describes the technical requirements, principles, test design, test process, method development and validation, and inspection rules for leak testing of pharmaceutical disposable process bags using pressure decay method.
1.2 This document is applicable to all pharmaceutical disposable process bags made of polymer materials used in pharmaceutical production, including 2D, 2.5D, and 3D storage bags, mixing bags, bioreaction bags, cryopreservation/thawing bags, filling bags, etc. These process bags include the bag body and the overall assembly of hoses and connectors.
1.3 The detection methods described in this document are applicable to both unused and used pharmaceutical disposable process bags.
1.4 This document does not specify the maximum acceptable leakage limit (MALL) for pharmaceutical disposable process bags or the method for determining it.
1.5 This document does not specify the time and frequency of leak testing or the number of samples to be tested.
1.6 This document does not specify the sensitivity required for the method. The detection sensitivity achievable by the method depends on the detection parameters and the volume of the sample. Pharmaceutical disposable process bag manufacturers or users need to determine the sensitivity required for leak testing based on their own production processes and risks.
1.7 Currently, the pressure decay method commonly used in the industry includes two types:
a) Method A: Pressure decay method without a restrictive plate;
b) Method B: Pressure decay method with a restrictive plate.

Development Information

Related Standards