Standardization News

A new ASTM International standard will help keep foreign particles out of biopharmaceuticals during the single use system (SUS) manufacturing process. ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which will soon be published as E3230. 

According to ASTM International member Klaus Wormuth, over the last 10 years, single-use bioprocessing equipment has become more widely used in biopharmaceutical manufacturing, providing significant flexibility. Wormuth notes that SUS also provides both economic and sustainability benefits compared to conventional stainless-steel equipment.

“Since single-use systems are not cleaned prior to user, the single-use manufacturer needs to take great care and produce the SUS equipment in a cleanroom environment to minimize particle levels,” says Wormuth, principal scientist, Sartorious. “Better methods are needed to determine if the SUS is indeed clean enough for application requirements.”

Wormuth says the new standard describes a procedure for developing a method that most efficiently rinses 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,” says Wormuth. 

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