Nelson Labs

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.

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/

Challenging the Status Quo of Sterile Environments

Terra Kremer, corporate relationship manager at Nelson Laboratories, was interviewed by Foreste Peterson for her series about conversations with inspirational Utah women in business. Peterson writes for the Utah Governor’s Office of Economic Development.

What brought you to Utah?

My parents brought me here from California because they loved the seasons.

What’s been your career path? How did you get started in the life sciences industry?

I am someone who has a lot of ideas. I try to think big and innovate. That being said, I spent a lot of time figuring out what exactly I wanted to do. I went to the University of Utah and studied chemistry. While I was in school, I wasn’t able to pay my bills, so I started waiting tables, which introduced me to the wine industry.

After I graduated, I moved to California and worked at U.C. Davis to study oenology, where I got my first glimpse into chemistry in a work setting. However, I realized that working at a winery in reality wasn’t very glamorous and that line of work wasn’t for me.

I then returned to Utah to help my sick younger brother. In the meantime, I started my first job in the health sciences industry at the DNA/Peptide Synthesis lab. I was still not in love with this job so I kept exploring.  Eventually I found myself at Nelson Labs where I joined the Sales Team. Right away, I loved the culture and was passionate about my new position that integrated business and science.

Can you explain what exactly you do and how it has an impact on medicine and patient outcomes?

My job, in particular, is to design test plans for medical devices, pharma and tissues to assure sterility. At Nelson we make sure our clients’ processes are in control and repeatable. As an example, I strive to ensure that there is no bioburden – bugs – on doctors’ tools that could potentially make patients sick. In broader terms, my job is to save lives!

Click HERE to read the full article.

3D Printed Devices and Biocompatibility

By: Matthew R. Jorgensen, PhD; Audrey P. Turley, B.S., RM(NRCM), CBA(ASQ)

3-D Blog Post

The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and morphologies available present a unique concern from a toxicological perspective. A range of standalone 3D printers are commercially available with compatible materials ranging from plastics to oxides and metals. Raw materials used in the fabrication process often have highly customized properties, achieved through the use of proprietary additives and specific microscale morphologies which can affect the overall biocompatibility of the finished device. Therefore, 3D printed medical devices require versatile approaches to the assessment of their biocompatibility that consider several factors which will be addressed in turn over this four-part blog series:

  1. Possible additives to raw materials which enhance workability
  2. Details of the material curing process
  3. Post-printing finishing and rinsing processes
  4. Time allowed for aeration between device manufacture and use

Possible additives to raw materials which enhance workability

3D printed plastic materials can be grouped by the printing technology used; generally either photolithography or direct writing of thermoplastic materials. In both of these cases, one or more materials are printed in tandem with a sacrificial filler material that provides structural support during the printing process. Photolithographic methods use a mixture of polymer precursors called photoresist which polymerize into a durable solid on exposure to light. If the photoresist requires light with intensity above a certain threshold, extremely fine resolution on the order of hundreds of nanometers is possible by scanning tightly focused laser light through the photoresist. Direct writing involves the partial melting of raw materials through a heated nozzle into fine layers. The structure and support material are deposited layer by layer, gradually building from the ground up. A compromise between photolithography and direct writing is also possible. In a process similar to inkjet printing, which produces thousands of colors by mixing three or four primary colors, different combinations of photoresists can be mixed and printed followed by exposure and polymerization with UV light.

Each technology for 3-D printing of plastic involves materials with highly customized properties, enabled by their unique chemistries. Photolithography involves polymer precursors, photosensitizers, other additives, and solvents. Following exposure, precursors and reaction byproducts remain embedded in the structure raising concerns regarding their potential to leach out during clinical use. Thermoplastics used in direct writing processes include plasticizers and other additives essential for their workability but which may cause concern as some of these additives are not biocompatible. Following melting and drawing through the writing nozzle, the additives are redistributed through the material and the surface area is increased exponentially. These processes increase the availability of potential toxicants to their surrounding matrix in the body and potentially a clinical exposure risk if not understood.

Evaluation of the biocompatibility of 3D printed devices should consider chemicals which are novel additives to otherwise well-known materials, as well as byproducts of the polymerization process. The availability of these chemicals for extraction into the matrix surrounding the device must be evaluated along with an assessment of their potential toxicological impact on a case-by-case basis.

Tune in next week to learn more about the details of the material curing process and the role it plays in the biocompatibility of 3D printed medical devices.