Cleanroom Renovation Complete

At Nelson Laboratories, our values hinge on quality, service, and expertise. Our quality systems and world-class facilities are part of what elevates us in the MedTech industry.

We recently completed a two-year renovation to our state-of-the-art ISO Class 5 cleanroom. This space is where we perform important product sterility testing.

“I commend our product sterility team and laboratory management for the great coordination and management of this project,” said Jeff Hone, Vice President of Quality at Nelson Laboratories. “This puts us in a state of compliance with our cleanroom that will serve us for years to come.”

During the cleanroom renovations:

  • The isolator testing units were moved to a new, dedicated testing space to allow for more room related to product sterility testing – (additional space for sample processing and storage)
  • The floors were resurfaced with a solvent resistant surface to improve the ability to clean
  • The cleanroom walls were replaced with a high end cleanroom surface which is chemical resistant, easily sanitized and highly durable
  • Two new laminar flow hoods were installed
  • Low particulate construction materials were used to improve particulate interface

If you have any questions, please contact the Sterility Department Section Leader, Jonathan Swenson, at jswenson@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.

Jeffery Nelson Contributes on Panel for Biomed Professionals

MedTech innovation leaders gathered at the University of Texas in San Antonio to share their expertise with up-and-coming biomed talent. The Health Cell, a life sciences professional development and advocacy organization, created a pilot workshop series Developing and Clinically Introducing Medical Technologies. The four-part workshop focused on enabling scientists to become entrepreneurs began in October of 2016.

jeff-nelsonPresident of Nelson Laboratories, Jeffery Nelson, participated on a panel during the third workshop held on Monday, January 16, 2017. The focus of this panel was research, product development, manufacturing, verification, and validation.

“The Health Cell concept is a great way to support the growing Med Tech industry sector in San Antonio,” said Jeffery Nelson. “I was impressed by the group and honored to be invited to participate in their learning process.”

The need to educate bioscience professionals spurred the creation of this workshop series,” reported The Rivard Report. “Participants will learn how to develop a medical technology or MedTech device from concept, where patient needs are identified and a market is selected, to product development, testing, and manufacturing, all the way to clinical trials and market introduction.”

The fourth and final workshop in the series will include the topic of financing the pathway followed by a presentation of awards on February, 13, 2017.

More information on upcoming The Health Cell events can be found HERE.

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/

Flexible Endoscope Surveillance Testing Webinar Now Available

AlpaPatelLast week, Alpa Patel, Senior Scientist at Nelson Laboratories, and Kaumudi Kulkarni, Manager of Research and Development at Healthmark Industries, hosted the live webinar Endoscope Microbial Surveillance Testing Made Easy. The webinar was attended live by infection prevention professionals, sterile processing professionals, nurse managers, laboratory professionals, and others who work in healthcare facilities and wanted to learn more about performing surveillance on endoscopes.

The webinar discusses the outbreaks that have been in the news over the past few years regarding contamination of flexible endoscopes, and the benefits of performing endoscope surveillance in a healthcare facility. An explanation of the organisms of concern is provided which allows Patel and Kulkarni to review the options for positive growth of the organisms. Basic tests methods for surveillance of flexible endoscopes are covered.

The 44 minute webinar is now available on-demand. If you would like to watch the webinar, follow this LINK.

For more information, contact Alpa Patel at apatel@nelsonlabs.com.