Rationale

This revision of E3230-20 is motivated by the recent publication of Guide E3466 and Practice E3468 that give development guidance and validation requirements for “particle quantification test methods” (PQTM) for the measurement of particulate matter on the surfaces of single-use systems (SUS). As defined in E3466 and E3468, a PQTM consists of three procedures: an extraction procedure, a test sample preparation procedure, and a particle measurement procedure. E3230 focuses on the extraction procedure and was written in the absence of E3466 and E3468. Thus, E3230 also needed to address aspects of particle measurement that are now covered in more detail in E3466 and E3468. This proposed revision of E3230 addresses these issues: (1) Narrowing the focus of E3230 to “qualification of extraction procedures” (title change) (2) Removing redundant sections now covered in E3468 and E3468: E3230-20 sections 4.7, 5.1.4, 7, A2.2 and X2 (3) Referencing E3466 and E3468 where needed (4) Harmonization of the terminology definitions in E3230 with those in E3466 and E3468