What Does the Medical Device Sterilization Validation Process Include?

So, you have a reusable medical device requiring sterilization. You’ve learned about the sterilization process, and perhaps even identified which method is ideal for your product. But there seem to be some validation requirements. You may wonder about your part in all of that as a device manufacturer. What exactly is included in that validation?

We’re here to break it down for you.

Medical device sterilization requires validation of processes. That validation achieves two things:

  1. It verifies the sterilization process will achieve consistent sterility
  2. The sterilization process will not have a negative impact on the device

You’ll want to find a reliable sterilization partner who can provide the sterilization services you need. Be sure they offer the sterilization validation your project requires. Validation includes several elements, all of which your sterilization partner will be responsible for. You’ll want to familiarize yourself with these, if only to have a general overview of the process and understand what to expect.

Sterilization validation elements

  • Sterilization cycle development
    Sterilization cycle development ensures that the sterilized load is actually sterilized. Additionally, it verifies the load will sterilize consistently.
  • Biological and physical measurement controls
    These verify if the necessary conditions are present to neutralize a specific number of microorganisms for an identified sterilization process.
  • Empty chamber studies
    These studies are performed to establish uniform heat distribution.
  • Loaded chamber studies
    Aligned with empty chamber studies, the loaded chamber studies identify if sterilization was achieved across the entire load without any over-processing.
  • Routine use / ongoing monitoring
  • Validation maintenance / Change control / Revalidation

Validation protocol: The written plan

You’ll need a written plan with a clear outline of your sterilization validation protocol to meet FDA guidelines. That should include how validation was conducted, test parameters, product characteristics, production equipment, and more. Some of that information will include details from the above elements.

The good news is that your sterilization partner may take care of that written protocol for you. Life Science Outsourcing (LSO) is one sterilization resource who will prepare the validation protocol and maintain its records for medical device manufacturers.

The validation report should include the following:

  • Purpose and objectives
  • Equipment
  • Tests performed and rationale
  • Detailed test methods
  • Acceptance criteria
  • Approvals
  • Effective date
  • Supporting documentation

But we’re not done yet! There is one more FDA requirement.

Validation Final Report

This documentation provides a high degree of assurance that a specific process will provide consistent results and is also required by the FDA.

This documentation should include:

  • Equipment assessment
  • Process testing results
  • Deviations and rationale for determining impact on the validation study
  • Meeting of acceptance criteria
  • Established processing parameters

It’s all in the records

The sterilization validation process is complex and thorough for a reason: to ensure your medical device has been sterilized with maximum effectiveness. The end result is a device able to do what it was intended to do and improve health outcomes for many.

The process and all its requirements may seem overwhelming. The key is to find the right partner to match with your needs, who can perform sterilization, validation, and documentation for your specific medical device. Educating yourself on the basic premise of the process will help you find that perfect resource.


The Life Science Outsourcing team is ready to help you with your project.

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