New ASTM Standard Addresses Foreign Particles in Biomanufacturing Processes

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The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

A new ASTM International standard addresses foreign particles created in the single-use system (SUS) manufacturing process, to ensure quality for SUS use in biopharmaceutical manufacturing. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which will soon be published as E3230, ASTM announced in an April 29, 2020 press release.

“Since SUS are not cleaned prior to use, the single-use manufacturer needs to take great care and produce the SUS equipment in a cleanroom environment to minimize particle levels,” said Klaus Wormuth, ASTM International member and principal scientist at Sartorius, in the press release. “Better methods are needed to determine if the SUS is indeed clean enough for application requirements.”

The new standard describes a procedure for developing a method to efficiently rinse SUS to extract foreign particles, which will allow for a more complete counting and identification of the particles.


“The new standard will help build trust between suppliers and end-users of SUS regarding the critical topic of particle cleanliness,” said Wormuth in the release.

Source: ASTM