Subcommittee E55.07 on Single Use Systems

Matching Standards Under the Jurisdiction of E55.07 by Status

Proposed New

  • WK74514 Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy

  • WK81610 Development and validation of test methods to quantify particulate matter on the surfaces of single-use assemblies designed for use in biopharmaceutical manufacturing

  • WK87243 Visual Inspection of Single-Use Bioprocessing Equipment

  • WK80957 Reporting and Classifying Cleanliness with Respect to Particulate Matter in Pharmaceutical Processes

  • 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

Withdrawn, Replaced