Nelson News

Of course – highlighting what’s new at Nelson Laboratories is a key goal of my blog to keep you informed about their service, quality and expertise.

2017 Mid-year Thought Leadership Update

The experts at Nelson Laboratories have been busy in 2017. They have participated on committees, spoken at domestic and international industry events, written whitepapers, published articles, and hosted webinars. We have compiled the list below to share some of our educational assets:

WHITEPAPER

WEBINARS

TECH THEATER

THIRD-PARTY PUBLISHED ARTICLES

To register for our three-day Science of Sterilization Validation seminar, visit the Seminar page on our website.

Complete EN 13795 Suite of Tests Offered by Nelson Laboratories

The European standard, EN 13795, addresses the barrier properties, cleanliness, and strength of surgical drapes, gowns, and clean air suits used to protect patients from secondary infections in the surgical suite. The standard was approved in 2011, updated in 2013, and is the current standard today.

Nelson Laboratories is proud to announce that we are able to perform the eight tests required to meet the EN 13795standard. The addition of Hydraulic Burst Test and Resistance to Dry Microbial Penetration Test in 2016 completed the suite of tests offered by Nelson Laboratories to help manufacturers meet the requirements of the European standard. The following tests have been certified by ANAB to meet the requirements of ISO/IEC 17025:2005:

  • HPT220 Resistance to Dry Microbial Penetration
  • HPT210 Resistance to Wet Bacterial Penetration
  • BIO220 Bioburden
  • PSA120 Particle Shed Analysis
  • HPT110 Hydrostatic Pressure
  • HPT230 Hydraulic Burst Test
  • PHY150 Tensile Test, Dry
  • PHY155 Tensile Testing

Manufacturers of surgical drapes, gowns, and clean air suits who will be marketing their products in Europe need to make sure their product offerings meet the requirements outlined by EN 13795. Additionally, meeting the requirements of this standard is important for manufacturers who are looking to obtain the CE label for their products.

For more information, contact Nelson Laboratories’ Protective Barriers department ProtectiveBarriersStudyDirectors@NelsonLabs.com.

Nelson Laboratories Science Council

By Martell Winters

I am very excited for this new stage of Nelson Laboratories. For many years I have envisioned that the replacement of Dr. Jerry Nelson would be more than just a single person. The replacement needed to be a small group of highly qualified individuals to help drive the science of Nelson Laboratories.

The Nelson Laboratories Science Council had its first meeting yesterday to confirm the regular participants and discuss the charter and membership qualifications. We have a clear vision of how we will be working together to help expand the knowledge within Nelson Laboratories.

“As we continue to expand as a global leader in microbiological testing services, our scientific expertise is a differentiator for us as a company,” said Jeff Hone, Vice President of Quality at Nelson Laboratories.  “I am so excited to be working with this wonderful group of scientists to expand our scientific knowledge.”

I will serve as the chair of the council, with Tonya Morris as the vice-chair. The regular members of the council are as follows:

  • Martell Winters (Chair; AAMI/ISO participant and co-chair, liaison to AATB standards committee)
  • Tonya Morris (Vice-chair; AAMI/ISO/PDA participant)
  • Thor Rollins (AAMI/ISO participant)
  • Wendy Mach (USP Expert Committee, AAMI/ASTM participant)
  • Michelle Lee (AAMI/ISO/ASTM participant)
  • Alpa Patel (AAMI/ASTM participant)
  • Emily Mitzel (AAMI/ISO participant and co-chair)
  • Dennis Ransom (Master Scientist – Nelson Laboratories)

I look forward to working with this excellent group as we help to improve the science of the 10 Nelson Laboratories facilities, and as we interact in our industry.

science-council

Nelson Laboratories Launches Redesigned Website

SALT LAKE CITY, UT – January 25, 2017 – Nelson Laboratories, a leading provider of testing services for Medical Device, Pharmaceutical, Tissue and life science companies today announced the launch of a new, redesigned version of its website, nelsonlabs.com. Highlights of the updated site include a cleaner and more attractive design, a more engaging user experience with enhanced search and navigation features, and clearer calls to action for new and existing clients exploring the site.

Changes have been made to the site-wide navigation to help clients discover and order testing services. The refreshed site includes improved navigation when finding a test, easier to locate events and resources, and an optimized mobile and tablet experience to improve the user experience. Specifically, the ability to request a quote or submit a sample are now more readily available. Global facility contact information has also been added.

“With the new design, we wanted to meet the needs of new and existing clients by providing intuitive navigation to our testing services while highlighting the educational and scientific resources we provide to the MedTech industry,” said Paul Huish, Marketing Director at Nelson Laboratories. “The design is intended to improve the user experience, and we believe our clients will notice and appreciate these changes.”

website-image

To see the updated site, visit www.nelsonlabs.com (https://www.nelsonlabs.com/).

About Nelson Laboratories:

Established in 1985, Nelson Laboratories, LLC is a business unit of Sterigenics International LLC and a leading provider of microbiological testing and consulting services for MedTech companies. We know that every test matters and requires solutions that improve patient outcomes and minimize client risk. It means working with customers to solve complex problems, providing precise test results, and delivering value through superior testing solutions and service to ensure the safety and efficacy of every product. Visit http://www.nelsonlabs.com for more information.

2016 Year in Review

GlobalServiceCenters

This past year was an exciting one for Nelson Laboratories! We were acquired by Sterigenics International in April. With the merger of Nelson Laboratories and Sterigenics’ SteriPro® Labs, our global facilities and expertise now allow us to continue investing in new services, equipment, and facilities. We have expanded our footprint to localize our portfolio of offerings with ten lab facilities in eight countries. We continue to develop our talent pool to provide the industry’s best lab services and expertise.

Over the next two years, we will be announcing facility renovations, service expansions, and organizational changes to help align our network of labs to meet expanding global needs. We appreciate the loyalty of our clients as we move forward – expanding on their trust.

We are excited and honored to serve the growing MedTech industry to fulfill our heart-felt mission to help the best companies in the world improve the quality of life.

This year, we strived to produce valuable resources to help our clients every step of the way:

WHITEPAPERS

Establishing Bioburden Alert and Action Levels

3D Printed Medical Devices and Biocompatibility

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

WEBINARS

The Power of Extractable / Leachable Chemistry for Medical Devices

Changing a Colorant in an Approved Medical Device, What Should I Know?

Focus on Fundamentals Day 1: Develop a Biological Evaluation Plan (BEP)

Focus on Fundamentals Day 2: Understanding Test Options

Focus on Fundamentals Day 3: Summarize all your Findings in a Biological Evaluation Report (BER)

How to Develop a Risk-Based Biological Safety Evaluation Per New US FDA Guidance

New Approaches to Assessing Biocompatibility for Medical Devices

When Do I Really Need to Perform an Ethylene Oxide Requalification?

Water Quality for Pharmaceutical and Medical Device Processes

THIRD-PARTY PUBLISHED ARTICLES

FDA Guidance for ISO 10993-1: What to Expect

  • MD+DI
  • January
  • Author: Audrey Turley

Sterilization Risk

  • ODT & ODT Online
  • February
  • Quoted: Martell Winters

Understanding Validation for Verification Dose Maximum Sterilization

  • MDT & MDT Online
  • March
  • Authors: Wendy Wagsgard and Sean Shepherd

Creative Proof

  • MPO & MPO Online
  • March
  • Quoted: Martell Winters

When Do I Really Need to Perform an EO Requalification?

  • MPO & MPO Online
  • April
  • Authored By: Dan Floyd & Paul Littley

Chemical Characterization Can Supplement and Support Biocompatibility Testing

  • Tech Briefs Online
  • April
  • Authors: Thor Rollins, Sarah Campbell, Audrey Turley

How Clean is Your Cardiovascular Device?

  • Medical Design Technology
  • April / May
  • Author: Emily Mitzel
  • Note: Featured Article

Testing and Sterilization Support, Integrated

  • Packaging Digest
  • May 24
  • Quoted: Jeff Nelson

Quick Guide to FDA’s Draft Guidance on 3D Printed Devices

  • MD+DI Online
  • May 24
  • Authored By: Matthew Jorgensen

Justifying Family Groupings to Maximize Value for Cleaning and Sterilization

  • Orthopedic Design & Technology
  • May / June
  • Authors: Emily Mitzel and Nick Workman

Medical Packaging Testing Discussion to take Center Stage at MD&M Minneapolis

  • Packaging Digest online
  • August 23
  • Featured: Wendy Mach as a panelist at MD&M Minneapolis

Pay Attention, This will be on the (Device) Test

  • Orthopedic Design Technology (ODT)
  • September / October
  • Quoted: Mathew Jorgensen, PhD and Thor Rollins

Top 3 Questions About Extractable / Leachable Testing

  • MD+DI Online
  • October 3
  • Author: Matthew Jorgensen, PhD

Considerations for Sterilization and Biocompatibility of 3-D Printed Orthopedic Devices

  • MD+DI Online
  • October 10
  • Authors: Thor Rollins and Matthew Jorgensen, PhD

Microbiologist Identifies Noncritical Device Disinfection Challenge

  • AAMI News
  • October
  • Author: Natalie Weber

New FDA Guidance for 501(k) Submission of Orthopedic Medical Implants

  • ODT
  • November / December
  • Authors: Martell Winters and Quinton Inglet

Validating IFUs for Reprocessed Medical Devices

  • MDB
  • December
  • Author: Emily Mitzel

How the New FDA Guidance on Biocompatibility Affects Medical Device Manufacturers

  • MD+DI
  • Authors: Thor Rollins and Audrey Turley

For real-time updates, follow our blog: https://nelsonmedtechinsights.com/

IMRP Roundup

The 40th International Meeting on Radiation Processing (iia) was held two weeks ago in Vancouver, Canada. Nelson Laboratories’ Senior Scientists Martell Winters and Wendy Wangsgard, PhD attended. Winters was the Program Chair and also led a preconference day workshop on dose audit failures. Wangsgard chaired the Healthcare Strand session on radiation microbiology. The discussion covered microbiology vs. math, updates to AAMI TIR35 and TIR17, and wrapped up with Winters presenting more in-depth details on dose audit failures.

Wangsgard presented a poster on “Validation of a Sterilization Dose for Products Using a 3D Printer.” Her presentation was very well received and earned the Best Poster award.

“I have been wanting to attend this meeting for 12 years, and I was delighted to be able to present a poster and chair a session,” Wangsgard explained. This was a very special day for Wangsgard as she not only was awarded the Best Poster award, but it was also her birthday.  “Little did I know that I would receive the greatest birthday present by winning this award and by celebrating with industry experts who I have been looking up to for decades!”

The conference was well attended and Nelson Labs will be attending the next one in two years.