ASTM 2016 Fall Meeting

Performance Validation will be participating with ASTM’s Technical Committee E55 October 11-13 at USFDA’s White Oak Campus in Silver Springs MD. The scope of E55 is the Manufacture of Pharmaceutical and Biopharmaceutical Products.

Day one of the meeting will consist of an E55 Workshop with members of FDA to discuss Current and Future Standards Activities within Pharmaceutical and Biopharmacuetical Manufacturing. This discussion will help to ensure current future standards help to meet the current and anticipated regulatory requirements.  While Day 2 and 3 of the meeting will be devoted to the review of standards in development by the main E55 and various sub-committees. Standards under review include:

  • Continuous Processing
  • Sampling
  • Particle Analysis Applications
  • Raw Material eData
  • Continuous Quality Verification
  • Single Use Systems in Pharma/Biopharma
  • Microbial Tests
  • Characterization of SUS Particulates
  • Integrity of Single Use Systems
  • Biocapability of Singe Use Systems
  • Single Use Systems Control Managment and Aseptic Processing
  • Extractables in Single Use Systems
  • BPOG/Leachables in Single Use Systems
  • Fill, Finish, and Distribution
  • Inactivation of Enveloped Viruses using Detergent

Do you use these types of standards in your work?  Want to get involved in the development of global standards that may shape the pharma/ biopharma industry?   A short video on ASTM membership follows:


Interested in becoming an ASTM member click here for to  request a membership application.