Cleaning Validations and Process Robustness: How to Build a Study Design

Posted by Dan Fowler, Principal Scientist on August 14, 2018

The process of cleaning medical devices, either in healthcare settings or at a third-party manufacturer, includes many operational steps and variables. To prove the robustness of process design and to validate that normal process variables do not impact a product’s acceptance criteria, a cleaning validation is executed.

To comply with the 2015 FDA Guidance on reprocessing of medical devices, the validation design for your product should prove the following:

  • That the manual or mechanical cleaning methods are adequate to allow the device to undergo processing to be reused safely, and
  • for devices cleaned in healthcare settings, that the reprocessing instructions themselves are effective in conveying the proper instructions to the user.

 Currently, the guidance document only contains regulatory thought on validation goals and does not outline how to build a study design that proves the cleaning methods are adequate and effective. That is where our knowledgeable and experienced experts come in; we work with you to design a study congruent with industry strategies and compliant with the guidelines.

We understand that cleaning validation is a type of process validation: the goal is to generate objective evidence and documentation that the processing methods consistently produce the predetermined results—while following industry practice and complying with the most recent standards and regulatory trends. We accomplish this goal by incorporating the following process validation principles:

Process Robustness—including collaborating on worst-case soil selection, helping to identify worst-case processing parameters and measuring cleaning capability

 Process Repeatability—including assistance with statistical sample size selection and confirmation of outputs and data consistency

 Process Reproducibility—including providing council on the number of efficacy cycles to consider based on industry trends, regulatory pulse, and risk/variable assessment on probability and impact

 Our study designs incorporate industry best practices, lessons learned, process validation principles and current regulatory inputs.

 To learn more about our thorough testing strategies, robust documentation and data integrity confidence, please contact us!

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Topics: Medical Device, Technical Expertise, Microbiology, Reprocessing, Regulatory Expertise