Standardization News

A proposed ASTM International standard will be used to aid physical integrity testing of single-use systems (SUS) in the pharmaceutical and biopharmaceutical industries. 

SUS equipment has become a popular alternative to stainless steel equipment that has been generally used for biopharmaceutical manufacturing processes. ASTM International’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) is developing the proposed standard.

The proposed standard will be used by SUS suppliers and end users to develop and validate physical leak and integrity testing systems. Regulatory bodies will also be able to use the standard to foster discussion related to integrity assurance with pharmaceutical/biopharmaceutical companies.

ASTM International member Marc Hogreve says that physical integrity testing as described in the proposed standard (WK74440) is highly recommended for evaluation of SUS integrity.

“The proposed standard focuses on practical aspects and interferences that should be considered when adapting well-established test methods, such as pressure decay or tracer gas, to be used on SUS,” says Hogreve, principal engineer, integrity testing, Sartorius Stedim Biotech. 

The proposed standard is part of a suite of related standards that include a standard for the integrity assurance and testing of SUS (E3244) and one on microbial ingress testing on SUS (E3251).

ASTM welcomes participation in the development of its standards. JOIN ASTM.

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