Product & Environment Validation
Product & Environment Validation
Radiation Sterilization ValidationFor 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. Dose Audit Services
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
- 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.
- 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.
- 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.
Ethylene Oxide (EO) Sterilization ValidationFor 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. Ethylene Oxide (EO) Testing
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)
Microbial Sampling TestsEnvironmental Air and Surface Sample
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. Microbial Counts
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.