Product and Environment Validation

WuXi AppTec Laboratory Testing Division Medical Device Platform’s technical and regulatory experts leverage their scientific knowledge of microbiology for product and manufacturing environment validations. The processes we validate are cleaning, disinfection, and sterilizing of reusable and third party reprocessed devices and sterilization validations of both radiation and ethylene oxide (EO). We also support ongoing product testing through dose audits of sterilized product. The manufacturing environment validation we offer includes environmental monitoring of water, surface, air and personnel protective equipment (PPE), as well as surface disinfectant efficacy studies. For these studies, we will also support your continued testing for your validated manufacturing environment.

Reprocessing Validations

Without a standard definition of clean, the responsibility falls to device manufacturers to ensure their cleaning and disinfection and/or sterilization instructions are adequate and comprehensive. Regulatory bodies expect device manufacturers to validate their instructions to demonstrate a reliable and repeatable process using worst-case scenarios. Our team will work with you to develop a test plan that meets these stringent guidelines. Our test plans and final reports support regulatory submissions, product adoptions, and testing confidence on device or process changes, and our approach remains the same. We construct a protocol and challenge the device to meet the latest regulatory expectations.

Sterilization Validation

All sterilization processes require validation of the efficacy and reproducibility of the process. WuXi Medical Device Platform offers a full range of services in this area – from stand-alone testing to complete validation management. Our technical experts collaborate with you to design the validation based on a sterilization method and manufacturing process that will meet regulatory requirements. We will continue to support the device testing with bioburden, sterility, microbial identification, and additional ongoing product safety testing.
For validation of radiation (gamma, electron beam or X-ray) sterilization, critical steps are outlined in ISO and AAMI standards. As part of the performance qualification, a dose setting or dose substantiation study must be performed to demonstrate the adequacy of the minimum dose to achieve the desired sterility assurance level (SAL). Several methods are available for validation of the minimum sterilization dose, and the choice of method is dependent on a number of variables. Our study design for complete radiation validation studies is for a specific product and process, and all aspects of the studies follow the requirements of ISO and AAMI standards.
With more than 25 years of experience and extensive knowledge of the regulatory requirements, WuXi Medical Device Platform offers unmatched expertise and the convenience of three levels of dose audit services. Your choice of service level depends on how much of your company’s time, manpower and expertise you want to commit to your ongoing dose audit program. Three Levels of Dose Audit Services
  1. At the most basic level, we provide only testing services while you schedule and manage all aspects of the sterilization process and develop all of the documentation to present an organized and compliant study.
  2. In addition to the testing, we can also handle all the sterilization services for you, and you would be responsible only for producing the final documentation showing compliance.
  3. We can take care of everything. You simply give us your product samples, and, at the end, we provide you with a complete summary report manual showing dose audit compliance.
For validation of ethylene oxide (EO) sterilization, critical steps are outlined in ISO and AAMI standards. As part of the performance qualification, a microbial challenge must be performed to demonstrate the adequacy of the process to achieve the desired sterility assurance level (SAL). One of the most utilized methods is the half-cycle (overkill) method, which uses a biological indicator (BI) challenge, typically 106 spores of Bacillus atrophaeus. Our study design for complete EO validation studies is for a specific product and process, and all aspects of the studies follow the requirements of ISO and AAMI standards.
Medical devices that are sterilized by ethylene oxide (EO) must be shown to have adequately degassed EO residues before the devices may be used. Analyses are performed for EO and ethylene chlorohydrin (ECH) according to current ISO and AAMI standards (10993-7). The allowable limits are for EO and ECH; no exposure limits are set for ethylene glycol (EG). The allowable limits are based on patient contact duration and are designated as limited (≤24 hours), prolonged (>24 hours and ≤30 days), or permanent (>30 days).
  • EO Residual Panel (Water Extraction) – EO, ECH, EG
  • EO Residual Panel (Headspace Extraction) – EO, ECH, EG
  • EO Water Analysis
  • EO Water Analysis – Exhaustive
  • EO Headspace Analysis
  • EO, ECH (Water Extraction)
  • EO (Headspace Extraction), ECH (Water Extraction)
  • ECH (Water Extraction)

Environmental Monitoring

In complex manufacturing environments, disruptions in production and unplanned downtime are inevitable. To support your environmental monitoring quality program, WuXi Medical Device Platform focuses on testing your water, air and surface samples. Our team will coordinate with your manufacturing facility to quickly test and report results. Our scalability supports overflow sample collection as well as large-volume testing when the unexpected occurs.

Microbial Sampling Tests

Growth on each environmental air (plate or strip) or surface (contact plate—e.g., RODAC) sample is enumerated. Gram stain and/or genus/species identification is available.
These assays are used as an indicator of the quality of water. Sample aliquots obtained from a water system are evaluated for a number of viable microorganisms. Specifically, coliform counts and pseudomonas counts can be enumerated.

Surface Disinfectant Efficacy

Study designs commonly follow the USP <1072> regulatory guidelines. In addition, our standard methods (ASTM, AOAC, USP, ISO, etc.) can be modified, expanded or customized. Our program design evaluates the log reduction of a disinfection process on hard surfaces. The study challenges a disinfectant surface in combination with a variety of microorganisms. We partner with manufacturers to support the feasibility study and validation of the disinfectant(s) that works best for your facilities. Our regulatory experts will work with you to design a validation that meets the latest regulatory guidances. Our flexible study designs, combined with our microbiology expertise, enable us to build a comprehensive, customized study that best suits your needs.