Examples of Recent Projects
Sterilization and Sterilizer Validation:
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Conduct all facets of annual re-validation for steam sterilizer for medical device contract test laboratory.
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Prepare EO validation protocol for 510(k) submission for manufacturer of catheter products.
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Review and revise protocol and final report for ethylene oxide / parametric release validation, for manufacturer of medical bandage products.
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Review EO validation protocol for manufacturer of cardiac catheter inflation products. Review and approve EO cycle equivalency/chamber equivalency process for same client.
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Conduct annual revalidation for hydrogen peroxide (STERRAD) sterilizer, for manufacturer of neonatal monitoring devices, and conduct another annual revalidation for manufacturer of orthopedic implants, and another for manufacturer of cosmetic surgical devices.
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Prepare SOPs for Product Adoption for gamma sterilization and steam sterilization processes for manufacturer of urological products. Prepare SOPs for Ethylene Oxide Product Adoption for manufacturer of catheter products. Prepare SOPs for Product Adoption/steam sterilization for manufacturers of spinal implants, and another for manufacturer for dental handpieces
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Conduct annual revalidation for prevacuum steam sterilizer, for human tissue bank / HCTP processor.
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- Advise and review cleaning validation reports, and subsequent IFU cleaning instructions, for manufacturer of cardiac catheter products; conduct similar review for manufacturer of urinary catheter/incontinence products.
- Conduct data analysis and prepare retrospective validation report to allow for reduced level of LAL gel-clot endotoxin testing (AAMI ST 72) for manufacturer of laser catheters. Complete similar project for manufacturer of cardiac catheter inflation products.
- Investigate bioburden variances and bioburden method validation for manufacturer of cardiac stent products.
- Prepare validation protocols for low-level disinfection and cleaning of sleep-apnea product. Troubleshoot laboratory issues, review IFU for product submission.
- Prepare protocols and execute validation for a) cleanroom cleaning process, b) cleanroom disinfection process, and c) cleanroom sporocidal process to meet USP <1072> and ASTM E2614-08. Develop screening for coupon material selection, develop test soil for validation assays.
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