1. Scope

Keywords

Rationale

Single-use systems have unique characteristics that differentiate them from medical devices. For example, SUS are typically orders of magnitude larger and/or are more complex (more components/connections) than medical devices in scope of bacterial endotoxins testing. Additionally, the fluid path surfaces are of greatest concern for SUS in contrast with all body contacting surfaces of a medical device. Currently there are no standards which define considerations for extraction and reporting practices for bacterial endotoxins testing on single-use components and assemblies. Endotoxin determination studies must be designed to reflect the intended use and manufacturing context of SUS, rather than relying on standards developed for patient-contacting medical devices. Lack of guidance specific to SUS limits the ability to assess the risk of the component or assembly to the final drug product. Standards addressing extraction and reporting of bacterial endotoxin results in medical devices (USP<161>, ANSI/AAMI ST 72, ISO 11737-3) are not practically applied to single-use assemblies (e.g. standard 40mL extraction volume) and reporting bacterial endotoxin results in EU/mL has obscured the transparency and comparability of results when standard extraction methods are not applied. Standardization for determination of bacterial endotoxin on single-use systems and components will result in improved assessment of risk to the final pharmaceutical/biopharmaceutical product.