Medical Device Cleaning & Sterilization Validation
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Medical Device Testing Services Catalog
Need to evaluate the cleaning, disinfecting, and sterilization processes for your medical device? WuXi AppTec is an experienced testing partner for device manufacturers. We can help you validate that your cleaning, disinfection, and sterilization instructions are comprehensive enough to meet your compliance needs.
Cleaning & Sterilization Validation Testing Tailored to Your Medical Device
Single-use and reusable medical devices must undergo a series of cleaning and sterilization validations to minimize risk to the patient. To do this, medical device manufacturers are responsible for validating that their cleaning, disinfection, and sterilization methods are reliable, repeatable, and compliant to the latest standards and scientific practices. WuXi AppTec’s technical and regulatory experts work with you to develop a test plan based on the sterilization method and manufacturing process.
Cleaning Validation Test Protocol
Cleaning validation testing ensures that the defined cleaning process effectively removes contaminants, such as bodily fluids, tissues, or manufacturing debris from the medical device.
Example tests include:
- Protein analyte residual testing
- Total Organic Carbon (TOC) analyte residual testing
- Hemoglobin
Disinfection Validation Test Protocol
Disinfection validation testing ensures that the medical device’s disinfection process effectively demonstrates a certain level of reduction in microorganisms. With a flexible study design combined with our microbiology expertise, our experts work with manufacturers to support the feasibility and validation of the disinfectant that works best for their facilities. WuXi AppTec offers expertise in both chemical disinfection and thermal disinfection methods.
For example:
- Low-level disinfection processes
- Intermediate-level disinfection processes
- High-level disinfection processes
Sterilization Validation Test Protocol
Sterilization validation testing ensures that the medical device’s sterilization process effectively neutralizes all microorganisms to achieve the desired sterility assurance level (SAL). WuXi AppTec’s technical experts collaborate with device manufacturers to design the validation based on a sterilization method and device design/configuration that will meet regulatory requirements. We continue to support device testing with bioburden, sterility, microbial identification, and additional ongoing product safety testing.
Specific tests include:
- Radiation sterilization testing
- Ethylene oxide (EO) sterilization testing
- Steam sterilization testing
Medical Device Cleaning & Sterilization Validation FAQs
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What is medical device cleaning validation?
Medical device cleaning validation ensures that the defined cleaning process effectively removes contaminants, like bodily fluids, tissues, or manufacturing debris from medical devices.
What is medical device disinfection validation?
Medical device disinfection validation ensures that the medical device’s disinfection process effectively demonstrates a certain level of reduction in microorganisms.
What is medical device sterilization validation?
Medical device sterilization validation ensures that the medical device’s sterilization process effectively achieves the desired sterility assurance level (SAL).
What are the regulatory requirements for medical device cleaning and sterilization validation?
Medical device cleaning and sterilization validation are guided by a number of standards:
- ISO 17664: Sterilization of medical devices
- ISO 14971: Medical devices — Application of risk management to medical devices
- AAMI 17665: Sterilization of health care products — Moist heat
- AAMI ST98: Processing of health care products – Quality management systems for reprocessing in health care facilities
- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities
- USP <1072>: Disinfectants and Antiseptics – Guidelines and information on disinfectants and antiseptics used in various healthcare settings
- ASTM F3127-16: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
- AOAC: Association of Official Analytical Chemists
What is medical device sterilization validation?
The SAL is the probability of a single viable microorganism remaining on a medical device after sterilization. In other words, it represents the acceptable microbial contamination limit. When conducting sterilization validation, medical device manufacturers must demonstrate that their process consistently achieves the desired SAL.