Work Item
ASTM WK74440

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

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

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

Rationale

This should be a complementary standard to E3244 and E3251, where it is placed in parallel to E3251 and below E3244 in the document hierarchy. It should be used by SUS suppliers and end users to develop and validate physical leak and integrity testing methods for SUS. Also, regulatory bodies can use this test method to facilitate the discussion related to integrity assurance with (bio) pharmaceutical companies.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E55.04

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-20-2020

Technical Contact: Marc Hogreve