New standard to help keep foreign particles out of biopharmaceuticals

ASTM International has released a new standard to help prevent the contamination of biopharmaceuticals with foreign particles during the single-use system (SUS) manufacturing process.

SUS refers to biopharmaceutical manufacturing (bioprocessing) equipment designed to be used once (or for a single manufacturing campaign) and then discarded.

The ASTM committee on the manufacture of pharmaceutical and biopharmaceutical products developed the standard, which will be published as E3230.

Klaus Wormuth, member of the international standards body, explained that single-use bioprocessing equipment has become more widely used in biopharmaceutical manufacturing over the last decade, providing significant flexibility. According to Wormuth, SUS also provides both economic and sustainability benefits compared to conventional stainless-steel equipment.

However, he added: 'Since single-use systems are not cleaned prior to use, the single-use manufacturer needs to take great care and produce the SUS equipment in a clean room environment to minimize particle levels. 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 that most efficiently rinses SUS to extract foreign particles, which allows for a more complete counting and identification of the particles.

It will help build trust between suppliers and end-users of SUS regarding the critical topic of particle cleanliness, Wormuth said.

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