ASTM E55 Meeting


This week, Brian Zylla and Rick van Doel are in Rockville, MD at the Institute for Bioscience and Biotechnology Research supporting ASTM’s E55 fall committee meeting.  ASTM’s E55 Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. Stakeholders include manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia.

Day 1 of the meeting focused on Single Use Systems (SUS), with a review of the following work items (draft standards that are in development):

  • Extractables Used in SUS (WK43975)
  • Integrity of single-use systems (WK43741 & WK47355)
  • Biocapatability of SUS (WK48956 & WK48957)
  • Characterization of SUS particulates (WK43742 & WK47356)

During the meeting an overview was provided of potential future standards that are needed by the SUS community.  This will result in the future development of an additional 20 standards.

Day 2 of the meeting will focus on review and update of the development of the following draft standards:

  • Continuous Processing (E2968)
  • Sampling (WK41265)
  • Design & Verification of Single Use Pharma & Biopharma (WK46541)
  • Particle analysis Applications (WK30195)
  • Continuous Quality Verification (E2537)

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