The focus of Kenny’s technology presentation — titled “Flushing It Out” and of interest to anyone who is bringing a device to market — will include:
* Regulations and Guidance, Background, Cleaning Validation Purpo
* Why Chemical Tests?
* Why Protein, Hemoglobin, and Carbohydrates
* Method Detection Limit vs. Device Detection Limit
* Validation Testing
* Test Soil
* Spiking Location
* Residual Protein, Hemoglobin, and Carbohydrate Assays
Flushing It Out will be presented at 12 p.m., Wednesday, April 25, in the Innovation Briefs Theater, Booth 1051, at BIOMEDevice Boston. Admission is free with BIOMEDevice Boston admission credentials. No reservations are needed.
Kenny has over 14 years of laboratory experience, including five supervising the Analytical Chemistry department at Microtest Laboratories, a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Kenny holds BS and MS degrees in chemistry and is the author of numerous articles, including the white paper, “Five Steps to Validating the Cleaning Process of Medical Devices,” available for download athttp://www.microtestlabs.com/
Kenny’s lab routinely performs cleaning validations on reusable and one-time use medical devices. In addition to medical device testing, the lab performs analysis of pharmaceutical drug products and combination products in support of all phases of development.
For more information, visit Microtest Laboratories at BIOMEDevice Boston in booth 1023, April 25-26, 2012. Or, visit Microtest’s web site athttp://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.
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Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/