1.1 This practice is applicable to all product path components (fluid or powders) of pharmaceutical and biopharmaceutical Single-Use manufacturing systems used for parenteral applications that have the potential to affect product quality and patient safety. It can be also used for applications of lower criticality. 1.2 For brevity, these are referred to throughout the rest of this practice as SuS (Single-use Systems). 1.3 This practice provides a standardized approach to perform a particulates impact assessment for SuS. 1.4 This practice is applicable to both new and existing SuS. The approach may be used for the implementation of changes to existing SuS, and their continuous improvement during operation. 1.5 This practice is applicable throughout the life-cycle of the SuS from concept to retirement. 1.6 This practice is intended to be used by SuS end-users. 1.7 This practice is not intended to be used by SuS manufacturer (Vendors).
Keywordsparticulates, single-use, biopharmaceuticals, impact, manufacturing
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development