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 WK91710 proposed Revision
- -See also WK88587 proposed Revision
- E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing
- -See also WK93446 proposed Revision
- E3231-19 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
- WK74514 Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy
- WK80957 Reporting and Classifying Cleanliness with Respect to Particulate Matter in Pharmaceutical Processes
- WK91364 Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
- WK81610 Development and validation of test methods to quantify particulate matter on the surfaces of single-use assemblies designed for use in biopharmaceutical manufacturing
- WK87242 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
- WK87243 Visual Inspection of Single-Use Bioprocessing Equipment for Particulate Matter