December 28, 2022

ASTM F04 Cleaning Validation Workshop - Call for Presentations

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May 9, 2023 - Setting Acceptance Limits for Cleaning Validation of Medical Devices

Sheraton Denver Downtown, Denver, CO, USA. For general information about the workshop, please visit the event website.


Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices, the workshop will be held in conjunction with the May standards development meetings of the committee.

This workshop will identify current best practices in setting acceptance limits in cleaning of medical devices, gaps in standardization of this practice, and areas where new standards would be useful. Considerations include crossover with ISO 10993 standards and potential updates to these requirements.

Workshop Topics

Topics include, but are not limited to:

    • Case studies of cleaning with issues associated with acceptance limits
    • Current standards on cleaning of medical devices
    • Types of residues and considerations
      • Include manufacturing residues, particles, environmental agents, cleaning agents
      • Exogenous factors
      • Knowing what your manufacturing materials are composed of
    • Methods for establishing acceptance limits
      • Historical clinical history
      • Toxicological risk assessment
      • Cytotoxicity
      • Patient risk assessment
    • Approaches for using acceptance limits in cleaning validation
      • How cleaning affects sterilization
      • How cleaning affects biocompatibility
      • Consistency of cleaning process
      • Impact of cleaning on device functionality or user experience
      • Risk assessment in using acceptance limits
    • When to modify acceptance limits
    • Approaches to limit establishment when there is a change in manufacturing process
    • What are the gaps in acceptance limits guidance?
    • The pharmaceutical manufacturer position on acceptance limits
    • Regulatory perspective on setting limits and rationale
    • Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices


Abstract Submission

Please submit your 300-word abstract pertaining to the topics above to Workshop Co-Chairs Stephen Spiegelberg at stephen.spiegelberg@campoly.com and Ralph Basile at rbasile@healthmark.com by close of business January 20, 2023.