Subcommittee E55.07 on Single Use Systems | ASTM

Subcommittee E55.07 on Single Use Systems

Matching Standards Under the Jurisdiction of E55.07 by Status

E3051-25 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
-See also WK88587 proposed Revision
E3230-25 Standard Practice for Qualification of Procedures for the Extraction of Particulate Matter from the Surfaces of Single-Use Bioprocessing Equipment
-See also WK93446 proposed Revision
E3231-19(2025) Standard Guide for Cell Culture Growth Assessment of Single-Use Material
-See also WK94174 proposed Reapproval
E3244-23 Standard Practice for Integrity Assurance and Testing of Single-Use Systems
E3251-23 Standard Test Method for Microbial Ingress Testing on Single-Use Systems
E3336-22 Standard Test Method for Physical Integrity Testing of Single-Use Systems
E3411-24 Standard Practice for Validation of Automated Membrane Microscopy Test Methods for the Counting and Sizing of Particulate Matter Present in Parenteral Pharmaceutical Manufacturing Processes and Final Drug Products
E3425-24 Standard Guide for Development of Automated Membrane Microscopy Test Methods for the Counting and Sizing of Particulate Matter Present in Parenteral Pharmaceutical Manufacturing Processes and Final Drug Products
E3466-25 Standard Guide for Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
E3468-25 Standard Practice for Validation of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
E3508-25 Standard Practice for Reporting the Counts, Sizes, and Types of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment

WK95245 Determination of Bacterial Endotoxin on Single Use Systems and Components
WK87243 Visual Inspection of Single-Use Bioprocessing Equipment for Particulate Matter
WK80957 Reporting and Classifying Cleanliness with Respect to Particulate Matter in Pharmaceutical Processes