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Medical Device Sterilization Validation
Why Companies Choose NAMSA
118K +
Medical Device Tests Run Annually
13
DABT Toxicologists on Staff
1967
Year NAMSA Started Testing Medical Devices
3,000+
Medical Device and IVD Manufacturers Supported Each Year
Advancing Patient Safety
Every manufacturer wants to do everything possible to prevent patient infections and ensure their devices are properly sterilized. However, it’s impossible to test every device for sterility as doing so would introduce new contaminants! By carefully validating the chosen sterilization method, manufacturers can eliminate the microbial load on the device to an acceptable level, ensuring patient safety.
Sterilization Validation Testing Services We Provide
The following are examples of components of the various sterilization validations that NAMSA can assist with.
- Bacteriostasis/fungistasis testing
- Bioburden testing
- Biological indicator sterility testing
- Dose audits testing
- Verification dose calculation
- EO cycle development testing
- EO residual testing
- EO fractional cycle study testing
- Growth promotion testing
- EO half-cycle study testing
- Monitor/notification of quarterly dose audit testing
- Pharmacopoeia sterility testing
Quick Facts About Medical Device Sterilization
- Sterilization methods must be validated to ensure patient safety.
- Various ISO standards cover sterilization including ISO 11137, ISO 11135 and ISO 17665.
- Your validation results will become part of your device’s design history file, the regulatory submissions and PMS documentation.
- Ethylene Oxide, radiation and steam are the most common methods of sterilization.
Experience With All Sterilization Validation Processes
NAMSA offers sterilization validation for processes including radiation sterilization by either gamma radiation or electron beam, ethylene oxide gas sterilization, hydrogen peroxide sterilization and thermal sterilization (both moist and dry heat).
We are renowned for our ability to create custom protocols that meet our clients’ testing budgets and are also supported by a complete documentation package that helps fulfill all regulatory requirements. Some of the methods we validate include:
Ethylene Oxide (EO): Suitable for heat-sensitive devices in compliance with ISO 11135. EO sterilization is a gaseous chemical sterilant that has a long-standing history with the sterilization of medical devices. Devices being sterilized must be packaged within a breathable-type package configuration (pouch or tray with Tyvek® lids) to allow the gas to penetrate into the device. NAMSA can assist in writing detailed validation protocols and reports, as well as the laboratory testing needed to support these validation protocols.
Radiation (Gamma or Electron Beam): Effective for various materials in compliance with ISO 11137 and ISO TIR13004. Radiation sterilization validations are based on the microbial resistance of the natural bioburden and bioburden population present on the device. There are many suitable methods that can be used to validate a device for radiation sterilization, and with the help of NAMSA technical experts they can determine which is the best method based on product material compatibility and also production volumes. NAMSA can assist in writing detailed validation protocols and reports, as well as the laboratory testing needed to support these validation protocols.
Steam (Moist Heat): Commonly used for reusable instruments in compliance with ISO 17665. Steam sterilization is a moist heat-under-pressure sterilization method that is conducted in an autoclave vessel using temperatures between 121°C (250°F) and 132°C (270°F). NAMSA conducts steam sterilization validations in support of reusable devices that need to be reprocessed in healthcare facilities between patient uses.
Low-Temperature Sterilization: Including hydrogen peroxide vapor, in compliance with ISO 22441 and ISO 14937. Another low-temperature sterilization modality is vaporized hydrogen peroxide, which like EO is chemical vapor. This method uses similar validation approaches as EO and is mainly used within healthcare facilities to reprocess medical devices, but this can be scaled up to be a terminal sterilization process for single-use medical devices. NAMSA can assist in writing detailed validation protocols and reports, as well as the laboratory testing needed to support these validation protocols.
Detailed Protocols Customized to Your Device
Each of these sterilization validation protocols are constructed specifically for your device and in compliance with the appropriate ISO standards, FDA guidance, or MDCG guidance. The detailed sterilization protocols and reports NAMSA creates have been extremely well received by regulatory agencies and have been acknowledged for their thoroughness by these agencies during reviews and audits.
Sterilization validations are considered “special processes” within most quality systems and regulatory bodies which require a focused approach to the execution of these studies. The sterilization validation information is a critical requirement for regulatory submissions and for ongoing compliance for any registered sterile medical device.
Meet Our Validation and Testing Experts
Meet the scientists and specialists ready to put their expertise to work for you.
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Ed Arscott, BS
Principal Strategy Consultant, MicrobiologyView Bio -
Marie-Eve Cluzel-Valentin
Principal Biological Safety and Validation ScientistView Bio -
Staci L. DeMoss, BS
Principal Validation ScientistView Bio -
Shelley L. Green, BS
Senior Validation ScientistView Bio -
Frédéric Cadoret, PhD
Senior Study Director, Sterility AssuranceView Bio -
Shazia A. Siddiqui, MS, NRCM
Principal MicrobiologistView Bio
Common Questions About Medical Device Sterilization Validation
Every device labeled as “sterile” has a regulatory requirement to ensure the validation of the sterilization process is conducted for the device. Any changes to the device (suppliers, manufacturing process changes, facility design modifications, packaging, etc.) should be evaluated for a determination if the change requires a full revalidation or some level of testing to support the changes do not affect the current validation. A formal master validation schedule for each type of sterilization validation should be documented with a prescribed interval for revalidation.
- EO – paper assessment every year, with a microbiological requalification every 2 years
- Radiation – quarterly dose audits (bioburden and tests of sterility) for each product family in routine production
This is a complex question and can be difficult to answer – a full review of the sterilization process, laboratory testing, and manufacturing process for the affected devices should be conducted with a sterilization expert and a team of internal quality and manufacturing personnel. Depending on the sterilization modality, there are options in certain ISO standards to assist in the re-validation process.
The choice of a sterilization method for a new medical device is a key design input, as different sterilization modalities will affect the materials and possibly the functionality, aesthetic color, and dimensions. The choices of materials and sterilization modality should be researched by the design engineers as part of the device development process. The use of AAMI TIR17 is recommended as it provides excellent guidance in the process of evaluating materials for all aspects of the device.
The regulatory submission requirements will vary on a country-by-country basis depending on the type of device and its intended use. A sterilized device does require the submission of all sterilization validation documentation, package integrity testing to support the sterility shelf-life claim of the device, and related bacterial endotoxin testing (if required by patient contact type).
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