Radiation Sterilization Validation

Accelerate Your Time To Market With Nelson Labs Accelerated Aging Testing!

Nelson Labs Accelerated Aging Promotion

Accelerate your time to market with Nelson Laboratories, Inc. medical device packaging validation services. For a limited time we are offering an accelerated aging discount of 28% off list price! To take advantage of this special promotional rate, contact your Nelson Labs sales representative for a quote at 801-290-7502, sales@nelsonlabs.com, request a quote, or submit samples.

PACKAGING VALIDATION OFFER:

  • Samples delivered to Nelson Laboratories for accelerated aging tests between 16 Sep 2014 and 31 Dec 2014 are eligible
  • Accelerated Aging discounted to $25/day (that’s a $10/day discount, or 28% off list)
  • Receive an additional 5% discount on post-aging packaging validation tests
  • Promotion valid for up to 3 years accelerated aging chamber time (generally 19.5 weeks)
  • Restrictions apply, see qualifying test parameters below

QUALIFYING TEST PARAMETERS:
Nelson Labs offers multiple chambers and parameter ranges to meet your needs. For our promotional event we have four parameters available. Promotional rate includes sample sizes up to 10 cubic feet. Sets larger than 10 cubic feet or requiring customized chamber temperatures are not eligible.

  • Parameter #1: 55 ± 4°C, 50% RH
  • Parameter #2: 60 ± 4°C, ambient RH (20-40%)
  • Parameter #3: 40 ± 4°C, ambient RH (20-40%)
  • Parameter #4: 30 ± 4°C, ambient RH (20-40%)
  • Submission window: 16 Sep 2014 – 31 Dec 2014

NELSON LABS PACKAGE TESTING SOLUTIONS:
Nelson Labs offers a wide variety of medical device packaging validations including but not limited to:

  • Package Types: Porous Packaging, Non-Porous Packaging, & Poly/Tyvek Tray Validations
  • Packaging Strength, Integrity & Shelf Life: Accelerated Aging, Real-Time Aging, Transportation & Distribution Simulation, Bubble Emission, Burst, Whole Package Integrity, Seal Peel, Dye Migration, Microbial Ranking, and more.

To learn more contact Nelson Labs’ sales at 801-290-7502, sales@nelsonlabs.com.

ABOUT ACCELERATED AGING:
The Accelerated Aging test simulates real-time aging of porous and non-porous materials. This test enables manufacturers to get their products to market faster. Nelson Laboratories performs this test in compliance with ASTM F1980 and ISO 11607 “Packaging for terminally sterilized medical devices.” Note that while accelerated aging is optional, real-time aging is required when establishing an expiration date.

QUESTIONS? VISIT NELSON LABS AT THESE UPCOMING EVENTS:

About Nelson Labs: Nelson Laboratories is a leading provider of testing and consulting services. We know that every test matters and requires solutions that improve patient outcomes. We call it The Science of Success™. It means working with clients to ensure the safety and efficacy of every product. Learn more at www.nelsonlabs.com.

MD&M Texas

MDM_Seminar_Event_imageNelson Laboratories will be exhibiting at the MD&M Texas show, May 7-8, 2014, at the Fort Worth Convention Center in booth #523.

Presentation: Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels of Bioburden Excursions

During the two-day conference and showcase Martell Winters, Senior Scientist at Nelson Laboratories, will be presenting a Learning Lab on Thursday May 8th from 10:00- 11:45 am. He will be presenting Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions to help manufacturers understand sterility assurance and bioburden data. Of interest to medical device manufacturers is the “absolute” necessity of a 10^-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels. These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.) and all product types, but are of special interest to combination products, biologics and tissues.

Register now for this exclusive event.

If you can’t make the Learning Lab presentation, Mr. Winters will also present at the Tech Theater on Wednesday May 7th from 1:00-1:30 pm on “Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?”. If you would like to meet one on one with Mr. Winters, he will be available in the Nelson booth for FREE consulting sessions, a $500 value. Availability will be determined on a first come, first served basis. If you would like to reserve a time for a consult in advance, please email mpizzi@nelsonlabs.com.

Below are topics that Mr. Winters will be available to discuss at MD&M Texas:

  • Radiation sterilization
  • Selection of SAL
  • Aseptic Processing
  • Evaluating of bioburden data
  • Bioburden alert and action levels
  • Environmental monitoring
  • Manufacturing microbiology

Don’t forget to stop by booth #523 to speak with Nelson representatives.

Location:
Fort Worth Convention Center
1201 Houston St.
Fort Worth, TX 76102
Booth #523

What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Radiation Sterilization Validation Overview

Martell Winters, Senior ScientistRadiation-sterilization

Martell Winters will present an overview on radiation sterilization at the 2014 MD&M West Conference. Martell is a Senior Scientist at Nelson Laboratories in Salt Lake City, Utah. His presentation will include:

  • Bioburden Testing: How it is performed and what constitutes a good bioburden count
  • Sterility Testing: How it is performed and how to avoid sterility test failures
  • Sterility Suitability Testing (also called B/F): How it is performed and how it relates to sterility testing
  • Radiation Validation: Review of applicable methods and standards
  • Case Studies: Review bioburden and sterility test data to understand approaches to a successful radiation sterilization validation

Take Away:

  • Attendees will learn how to evaluate bioburden data for establishing and monitoring radiation sterilization processes
  • Attendees will be educated as to how method suitability testing can help them receive the best sterility test results the first time around
  • Attendees will gain an understanding of what typically causes sterility test failures and how to avoid them

Details:

Martell will present for approximately one hour at the Nelson Labs classroom in 208AB on February 12, 2014 at 1:00 PM.

Register at www.canontradeshows.com/expo/west14/conference-nelson-rsvp.html

Nelson Laboratories website: www.nelsonlabs.com

Nelson Laboratories To Provide Materials Selection, ISO 10993 and Reprocessing of Reusable Devices-Validation Updates at 2014 MD&M West

SALT LAKE CITY – Jan. 31, 2014 – Nelson Laboratories (www.nelsonlabs.com) will conduct MD&M-West-Seminartwo classes for medical device manufacturers at the 2014 MD&M West Conference Feb. 12 beginning at 10:00 a.m. in room #208AB covering the most up-to-date information on material selection, ISO 10993 biocompatibility and reprocessing of reusable devices at the Anaheim Convention Center.

Nelson Laboratories will exhibit in booth 3228.

Additional medtech classes will include industry updates and information on ethylene oxide and radiation sterilization validation, packaging test methods and processing validations for newly manufactured devices.

Thor Rollins, biocompatibility specialist at Nelson Laboratories, will present an overview of changes the FDA made in its draft document regarding the implementation of ISO 10993, and insights into making smarter decisions when choosing materials for medical devices early in the validation process.

“Medical device manufacturers can save a lot of time and cost if they make smarter material selections before design begins,” said Rollins. “We’ll show you how, and provide the latest updates on what the FDA is thinking regarding ISO 10993 before the changes become an official guidance document.”

Emily Mitzel, laboratory manager at Nelson Laboratories, will discuss human factors in reprocessing reusable device validations. She will address three specific residuals and the exact amounts appropriate for cleaning that came out of the AAMI/FDA round table discussion on “How clean is clean?” and many more industry updates on cleaning and sterilization validations for reusable medical devices.

Nelson Laboratories’ complete class schedule in room 208AB will include:

  • 10:00 a.m. Materials Selection and ISO 10993 Biocompatibility Update – Thor Rollins, Biocompatibility Specialist
  • 11:00 a.m. Ethylene Oxide Sterilization Validation Overview – Dan Floyd, Laboratory Manager
  • 1:00 p.m. Radiation Sterilization Validations Overview – Martell Winters, Senior Scientist
  • 2:00 p.m. Packaging Test Methods for Validation of Sterile Barrier Materials – Wendy Mach, Packaging Section Leader
  • 3:00 p.m. Process Validations for Newly Manufactured Devices-Is your New Device Clean? – Alexa Tatarian, Study Director
  • 4:00 p.m. Managing Human Factors in Reprocessing of Reusable Devices-Validation Considerations – Emily Mitzel, Laboratory Manager

Click here for class registration. Nelson Laboratories will be available at booth 3228 for the duration of MD&M West Feb. 11-13.

In addition, Emily Mitzel will present a free class at the Tech Theater Tuesday, Feb. 11 from 1:40-2:10 in booth 635. She will present “Healthcare Reprocessing of Medical Devices and Human Factors Debrief.”

About Nelson Laboratories: Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. We are known for exceptional quality, but we look beyond the testing process and partner with you to achieve your long-term business goals. It’s what we call The Science of Success™. It’s transparency in the testing process. It’s approachable experts that guide you through ever-changing compliance requirements. It’s helping you mitigate risk, be first to market, and succeed with your customers. Learn more at www.nelsonlabs.com.

Increase Efficiency by Combining Bioburden and Tests of Sterility

By Sean Shepherd, Sr. Study Director, Bioburden, BS, SM/RM(NRCM)Bioburden-testing

When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device manufacturer. Nelson Laboratories suggests it is more cost effective and a better use of time to have both tests prepared as a single report at the same time and same location.

As a result, Nelson Laboratories provides a coordination service of the initial bioburden and sterilization validations along with a full validation report. The initial validation is then used as a reference for on-going quarterly dose audits.

The main advantage is that one report covers all areas of the ISO – AAMI 11137-2 standard requirements. Using this combo approach is a much more thorough and economical way to meet the standard.

The bioburden determination provides information on microbial levels of your device before it is sterilized. The test of sterility provides validation of a selected sterilization dose to achieve a 10-6 sterility assurance level for a medical device.

Nelson Laboratories has staff and resources completely devoted to providing the combined service. The package combines four tests into one report and also includes gram stain of the most prominent bioburden organisms, which is important in establishing a baseline if you don’t already have years worth of data.

Using this coordinated service, medical device manufacturers receive all of the results under one report. The report provides bioburden levels and a report of the test of sterility per the guidance outlined in the AAMI/ISO 11137-2 standard. This service is provided for both initial dose substantiation and quarterly dose audit testing. Nelson Laboratories also provides the final report compilation for the manufacturer who generally would have to do it themselves.