The guide will address variability in assessing bacterial endotoxins on large-scale pharmaceutical equipment.
Jul 18, 2025
ASTM International’s manufacture of pharmaceutical and biopharmaceutical products committee (E55) is developing a proposed standard for single-use systems (SUS) used to manufacture drugs.
The proposed standard (WK95245) aims to address a gap where the processes for assessing bacterial endotoxins on large SUS are left up to the interpretation of the manufacturer, test laboratory, or SUS user.
According to ASTM member Emily Alkandry, WK95245 will define important considerations for extraction and reporting levels of bacterial endotoxins present. Factors will include test article (for example, single-use assembly), surface area, or volume of the specified equipment and volume of extraction.
“Bacterial endotoxins are fever producing compounds. All pharmaceutical and biopharmaceutical drug products are tested for bacterial endotoxins to ensure patient safety,” says Alkandry, analytical services and quality control manager at Saint-Gobain Performance Plastics. “Single-use systems are commonly used to manufacture these drug products. However, these systems can be quite large, and there is a gap in how we test them and interpret the results.”
WK95245 is under the jurisdiction of E55’s single-use systems subcommittee (E55.07). This effort directly relates to the United Nations Sustainable Development Goal #3 on good health and well-being.
ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.
September / October 2025
