Standard Test Method for Physical Integrity Testing of Single-Use Systems

Importancia y uso:

4.1 The test methods outlined in this standard allow for suppliers and end users of SUSs in (bio)pharmaceutical manufacturing processes to detect a leak and/or confirm the barrier properties of empty, clean, and dry SUSs. Performing integrity testing can be a significant contribution to the overall integrity assurance of SUSs.

4.2 The two types of physical test methods outlined in this standard are:

4.2.1 Section 5, Pressure-Based Test Methods.

4.2.2 Section 6, Tracer Gas-Based Test Methods.

Note 3: Other test methods are currently being adapted for robust, reliable, and reproducible testing SUS, for example, Vacuum Decay Test Method as described in Test Method F2338.

4.3 Pressure-based test methods are generally less sensitive compared to tracer gas-based test methods but have a lower complexity and cost. To assist in selecting a method that will fit an application, refer to Table 1 in Practice E3244 for a more detailed comparison of the two methods.

4.4 Both types of test methods can be used to detect leaks of any sizes in a SUS (referred to as leak testing) or confirm the barrier properties of the SUS (referred to as integrity testing).

4.5 To ensure that integrity testing performed on SUSs is effective and accurate, the properties of the SUS (pressure capabilities, volume, material properties, etc.) must be considered. Also, a validation should be performed on the chosen test method as further described in 5.11 and 6.11.

4.6 Practice E3244 should be referenced to determine the maximum allowable leakage limit for a SUS, along with the routine testing requirements that are suitable for each application.

4.7 The purpose of the described test methods is not to stress the SUS until a potential defect occurs. The testing parameters, mainly test pressure, are independent from the use-case conditions. The robustness of the SUS under use-case conditions should be proven during product qualification.

4.8 This standard test method describes the test method principles, the apparatus designs, and method validations. For more detailed visualization of test setups and tested SUS designs, refer to Practice E3244 and more illustrative technical guides (5).

Subcomité:

E55.07

Referida por:

E3244-23, E3251-23

Volúmen:

14.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

flow testing; helium testing; integrity assurance; integrity testing; leak testing; liquid leak; microbial integrity; pressure decay testing; single-use system (SUS); single-use system integrity (SUSI); single-use system integrity testing (SUSIT);