Compliance Corner

• A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considernations of "Objectionable Organisms"
  • Source: American Pharmaceutical Review, January 2012
• The Quality Game: The pressure is on as companies strive to hit an ever-increasing number of moving targets. It’s not a pastime for the faint of heart.
  • Source: ODT Magazine, Nov/Dec 2011 issue
• A change to AAMI/ISO 11737-2 affects the Bacteriostasis/Fungistasis test
• AAMI Working Group 2 for Radiation Sterilization publishes new TIR 40:2009
• Recent views from the FDA on Gentoxicity testing
  • Source: FDA.gov
• FDA to test BPA Exposure from medical devices
  • Medpagetoday.com
• "Be in the Know about EtO: Expedited processing and better controls amp up the efficiency of ethylene oxide sterilization while revised standards affect validation"
  • Source MPMN, May 2009
• "FDA Recommendations to Industry Regarding Outsourcing: How to ensure compliance in the outsourcing environment" 
  • Source: BioPharm International.com, April 2009 
• "Benefits of Effective Communication with a Contract Analytical Laboratory: How to handle out-of-specification results in contract analytical work."
  • Source: BioPharm International.com, April 2009
• "Following the Road to Regulation:  FDA's goal is to address the gaps in regulatory oversight of certain diagnostic assays."
  • Source: MDDI, February 2010
• FDA Inspections for 21 CFR 111 (Dietary Supplements) will become common
  • Souce:  Labcompliance News.com
• "How to Feel Positive about a Biocompatibiity Failure" 
  • Source: MedicalDeviceSummit

If you have a challenging testing question, we have an answer. Our approachable experts are always happy to respond to your questions. Use this form to select your expert and submit your question.

The Nelson Labs Account Management team is here to help. Each account manager is trained and educated on the many testing options. Please feel free to reach out to one of our qualified Account Mangers.

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Dan Floyd Expertise: Ethylene Oxide Sterilization
Biography: Dan Floyd is the Sterilization Section Leader at Nelson Laboratories, Inc. For the last 18+ years he has specialized in all aspects of EO validations including cycle development, D-value determinations, bioburden resistance studies, biological indicator sterility testing, BI incubation reduction studies, comparative resistance testing, PCD development, and temperature and humidity distribution studies. Dan has performed onsite validations of sterilizers domestically and abroad both at contract sterilization facilities as well as for customers sterilizing product in house. Recently Dan has become involved with vaporized hydrogen peroxide sterilization validations and has had experience with EO, steam, dry heat, vaporized hydrogen peroxide, liquid chemical sterilants, and ozone sterilization. Dan received his B.S. in microbiology and a minor in chemistry from Brigham Young University where he attended on a Presidential scholarship. He has been with Nelson Laboratories, Inc. since 1992. Following graduation he became a registered microbiologist with the National Registry of Microbiology. Dan is a participating member of several AAMI working groups including industrial ethylene oxide sterilization, biological indicators, BIER/CIER vessels, and Process Challenge Devices.

Thor Rollins Expertise: In-vivo Biocompatibility
Biography: Thor Rollins is a certified microbiologist, RM(NRCM) with the National Registry of Certified Microbiologists and has been with Nelson Laboratories, Inc. since 2002. Currently, he is the In-vivo Biocompatibility Subcontracting Section Leader, and from 2002-2006, he was the study director over cytotoxicity. He specializes in the In-vitro and In-vivo biocompatibility tests and actively speaks on the topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the Northern California Biomed ASQ group meeting in 2010 and had an article published in the July / August 2010 issue of Medical Design Technology entitled The Big Three: Cytotoxicity, Sensitization and Irritation. He is a participating member on all AAMI 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, and discussing and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare Nelson Labs and its clients for changes in testing. Thor studied engineering at Colorado School of Mines and received his B.S. in biology with an emphasis in cell biology and genetics from Idaho State University.

Michelle Lee Expertise: In-vitro Biocompatibility, Ethylene Oxide Sterilization
Biography: .

Tonya Morris Expertise: Filter Sterilization/Filter Testing, Particulates, Disinfectants
Biography: .

Dr. Jerry Nelson Expertise: Microbiology, Sterility, LAL, Sterilization
Biography: Jerry R. Nelson, Laboratory Directory at Nelson Laboratories, has a Ph.D. in microbiology and immunology from the University of Utah. He is a member of many standards writing committees and associations including the New York Academy of Sciences, American Society for Quality, Parenteral Drug Association, American Society of Testing and Materials, Association for Advancement of Medical Instrumentation, Society for Pharmaceutical Engineering and the American Society for Microbiology. He has published dozens of articles in the scientific literature. He is an adjunct professor of bioengineering at the University of Utah and an adjunct assistant professor of microbiology at Brigham Young University. Jerry was named by MD&DI magazine (2004) as one of the top 100 notable individuals in the medical device industry. Jerry and Lynda Nelson were also finalists in the Utah Entrepreneur of the year sponsored by Ernst & Young for their company, Nelson Laboratories, Inc.

Emily Mitzel Expertise: Reprocessed Devices, Cleaning Validations
Biography: Emily Mitzel received her Bachelor of Science and Master of Science degrees in Microbiology from North Dakota State University. Her masters research focused on the development of biochemical and immunological methods to detect a specific strain of a plant pathogen of potatoes. Emily has been with Nelson Laboratories, Inc. for almost nine years. She is the Laboratory Manager over the Hospital Reprocessing, Pharmaceuticals and Microbiology sections. Nelson Laboratories’ Hospital Reprocessing Section validates product-specific cleaning, disinfection, sterilization, and functionality procedures for reusable devices between patient uses. She is also a member of many AAMI standard committees.

Todd Hillam Expertise: Barrier Material Tests
Biography: Todd Hillam received a Bachelor’s degree in microbiology from Brigham Young University and a Masters of Business Administration from the David Eccles School of Business at the University of Utah. Todd has worked at Nelson Laboratories for over ten years. He started in the ID’s/Packaging section as the study director of accelerated aging and bacteriostasis/fungistasis testing. He has been the Section leader of the Aerobiology department for over eight years where they test the barrier efficacy of Personal Protective Equipment (PPE) and other barriers. Todd is a Specialist Microbiologist with NRCM and a Certified Quality Engineer with ASQ. He actively participates in several standards committees (ASTM International, AAMI, and CEN) and currently serves as the secretary with ASTM F23.40 Biological Protective Clothing subcommittee.

Tina May Expertise: Analytical Chemistry
Biography: Tina May has managed the chemistry department for Nelson Labs since 2004, until her recent promotion to laboratory manager of the chemistry, bacterial endotoxin (LAL), and aerobiology departments. Tina specializes in analytical chemistry and cleaning validations for newly manufactured devices. Prior to working for Nelson Labs, she worked in the environmental industry for 10 years and held the positions of quality manager and laboratory director of a certified EPA laboratory. Tina is a member of ASTM F04 - Medical and Surgical Materials and Devices. She has a B.S. in chemistry from the University of Utah.

Wendy Mach Expertise: Packaging
Biography: Wendy Mach, B.S., RM (NRCM), CQA (ASQ), CPLP-tech (ISTA), is the Packaging Section Leader at Nelson Laboratories. Since 2004, she has overseen the integrity, strength and microbial barrier tests in the packaging department. After 17 years of testing medical devices, Wendy is an expert in packaging validations, sterilization validations, and microbiology testing. Before joining Nelson Labs, she worked as a lab supervisor managing the testing of sterility, microbial limits, bioburden, limulus amebocyte lysate, and antimicrobial effectiveness. Wendy began her career as a microbiologist performing in-house verification and validation. Wendy is on the F02 committee for flexible barrier packaging of the American Society for Testing and Materials (ASTM) and is a member of the Association for the Advancement of Medical Instrumentation (AAMI) packaging work group. She was invited to be a speaker and panelist on package testing at OrthoTec 2011. Wendy graduated with a B.S. in biology from the University of Minnesota.

Martell Winters Expertise: Radiation Sterilization, Bioburden studies
Biography: Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. He has been at Nelson Laboratories for 17 years and spent most of that time heading the Radiation Sterilization group, which is responsible for bioburden testing and radiation validation studies. He is currently a Senior Scientist for Nelson Laboratories. Mr. Winters serves on the AAMI Microbiological Methods, Sterility Assurance Level, Radiation Sterilization, General Criteria for Sterilization and Terminology Working Groups. He is currently heading the AAMI task force for a document regarding sterilization of tissue products. He is also on the AAMI Sterilization Standards Committee and on the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the National Registry of Certified Microbiologists.

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