Standard Practice for Integrity Assurance and Testing of Single-Use Systems

Importancia y uso:

4.1 This practice provides:

4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal.

4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing.

4.1.3 Information on the main challenges faced when testing SUSs for integrity.

4.2 This practice can be used by SUS suppliers and SUS end users to define an integrity assurance strategy for SUSs, with the relevant tests when appropriate.

Subcomité:

E55.07

Referida por:

E3336-22, E3251-23, E3326-22

Volúmen:

14.01

Número ICS:

55.020 (Packaging and distribution of goods in general)

Palabras clave:

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