Sterigenics

Sterigenics International and Noxilizer Announce Partnership

Sterigenics International and Noxilizer announce partnership to provide NO2 sterilization for pharmaceutical, biotech and medical device products

Agreement supports customers with global manufacturing networks

October 3, 2017 (Baltimore, MD and Broadview Heights, OH) Noxilizer, Inc. and Sterigenics International LLC announce the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries.

NO2-based sterilization was first commercialized by Noxilizer in 2012. Customers prefer nitrogen dioxide sterilization for its key advantages: ultra-low temperature (10°-30°C), minimal pressure requirements, no cytotoxic residuals, and fast cycle times (2-4 hours, including aeration). NO2 sterilization opens new avenues for medical device innovation and has been shown to be particularly effective in the sterilization of prefilled syringes, drug-device combination products, and custom implants.

“We are very excited about our partnership with Sterigenics, as together we can rapidly expand NO2 sterilization capability for our customers,” states Lawrence Bruder, President & CEO of Noxilizer. “Noxilizer’s customers will now have large-scale facilities to meet their needs for contract services, redundancy and increasing volumes.”

“Sterigenics is committed to providing our customers with efficient, state-of-the-art sterilization services using the processes best suited to their specific products,” says Philip Macnabb, President of Sterigenics. “We regularly monitor new technologies and are excited to be able to add NO2 processing to our suite of offerings.”

Noxilizer expects to have the first NO2 sterilization systems in place and operational in select Sterigenics’ facilities in the United States and Europe by the end of the year with additional installations to follow. As part of the agreement, Sterigenics will also offer nitrogen dioxide sterilization consulting services to its customers.

Customers will also be able to benefit from the integrated testing services available through Sterigenics International’s Nelson Laboratories business.  “This unique combination of cutting edge sterilization technologies, expert consulting support, and full-service testing services will provide customers with unrivaled support in getting products to market quickly and reliably,” says Jeff Nelson, President of Nelson Labs.

“Sterigenics has set a high standard for matching the needs of its customers with the best available sterilization technologies,” Lawrence Bruder concluded. “Noxilizer shares this commitment to excellence and we look forward to working with the Sterigenics International team as they continue to reshape the market.”

About Sterigenics International LLC:

Sterigenics International LLC, along with its affiliates, is a global leader in outsourced contract sterilization services, laboratory services, gamma technologies and medical isotopes, and the only vertically integrated sterilization company in the world. Operating out of 51 locations in 13 countries across the Americas, Europe and Asia, Sterigenics provides contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries. Its affiliate Nordion positions Sterigenics as the world’s largest provider of Cobalt-60 used in the gamma sterilization process as well as medical isotopes used in the diagnosis and treatment of various diseases and cancers. Through Nelson Labs, Sterigenics offers microbiological and analytical testing and consultancy to assist customers in developing and maintaining sterilization solutions in medical devices, tissue/implantable products, and pharmaceuticals and biologics fields. Sterigenics International LLC and its affiliates serve more than 2,500 customers around the world and is owned by private equity firms Warburg Pincus and GTCR. Learn more about Sterigenics at sterigenics.com, about Nordion at nordion.com and about Nelson Labs at nelsonlabs.com.

About Noxilizer, Inc.:

Noxilizer, Inc. provides an ultra-low temperature nitrogen dioxide process that offers many benefits over traditional sterilization and biodecontamination methods. Noxilizer sells sterilization and biodecontamination equipment to pharmaceutical, biotech and medical device manufacturers. Noxilizer’s expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process. Noxilizer, Inc. has offices in the United States and Japan. For more information, please visit: www.noxilizer.com.

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/

Sterigenics International has Acquired Nelson Laboratories

DEERFIELD, IL AND SALT LAKE CITY, UT — APRIL 4, 2016 – Sterigenics International LLC, the leading global provider of contract sterilization, gamma technologies and medical isotopes, and a portfolio company of Warburg Pincus and GTCR, today announced that it has acquired Nelson Laboratories, Inc., the largest U.S. provider of life-cycle microbiology testing services for the medical devices, pharmaceutical and tissue industries. Terms of the transaction were not disclosed.

Nelson Labs employs 570 professionals, including more than 300 scientists and 60 registered and specialist microbiologists.  With 85 labs running out of five corporate buildings in Salt Lake City, they work with more than 3,000 client companies in 57 countries, providing more than 400 microbiological and analytical tests.

All Nelson Labs operations will remain in Salt Lake City and be combined with Sterigenics’ existing microbiological and analytical testing and consultancy – SteriPro® Labs.  Moving forward, the combined entities will go to market under the Nelson Labs brand name and operate as a standalone business unit within Sterigenics International.  Jeffery Nelson will serve as President of Nelson Labs and together, with the Sterigenics contract sterilization business, will create the largest fully integrated global sterilization and lab services firm in the world.

“This is a significant strategic acquisition to help build out Sterigenics’ lab testing and service capabilities on a global scale, enabling us to better serve our multinational customers,” said Michael Mulhern, CEO of Sterigenics International.  “We will continue to explore additional expansion opportunities for our lab services to meet our customers’ growing needs.”

“We are incredibly impressed with Nelson Labs’ leadership, culture, customer oriented service and commitment to quality,” continued Mulhern. “We believe that the fit is perfect with Sterigenics and look forward to working together on our shared mission of improving global public health.”

“Sterigenics will be a great partner, and will provide the global access and ongoing investment necessary to ensure long-term growth of the lab services business,” said Jeffery Nelson. “They are a global leader in contract sterilization and sterility assurance serving the same markets as Nelson Labs. This is an excellent cultural fit, and I’m excited for the opportunities this will bring for our teams and our customers throughout the world.”

PriceWaterhouseCoopers served as accounting advisors and Holland & Knight LLC provided legal counsel to Sterigenics International.  D.A. Davidson & Co. served as financial advisors, Tanner LC served as accounting and tax advisors and Parsons Behle & Latimer provided legal counsel to Nelson Labs.

About Sterigenics International LLC
Sterigenics International LLC, along with its affiliates, is a global leader in outsourced contract sterilization services, gamma technologies and medical isotopes, and the only vertically integrated sterilization company in the world. Operating out of 48 facilities in 13 countries across the Americas, Europe and Asia, Sterigenics provides contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries. Sterigenics offers microbiological and analytical testing and consultancy to assist customers in developing and maintaining sterilization solutions in medical devices, tissue/implantable products, and pharmaceuticals and biologics fields. Affiliate Nordion positions Sterigenics as the world’s largest provider of Cobalt-60 used in the gamma sterilization process as well as medical isotopes used in the diagnosis and treatment of various diseases and cancers. Sterigenics International LLC and its affiliates serve more than 2,500 customers around the world and is owned by private equity firms Warburg Pincus and GTCR.

About Warburg Pincus
Warburg Pincus LLC is a leading global private equity firm focused on growth investing. The firm has more than $40 billion in assets under management. The firm’s active portfolio of more than 120 companies is highly diversified by stage, sector and geography. Warburg Pincus is an experienced partner to management teams seeking to build durable companies with sustainable value.

Founded in 1966, Warburg Pincus has raised 15 private equity funds, which have invested more than $55 billion in over 750 companies in more than 35 countries.  The firm is headquartered in New York with offices in Amsterdam, Beijing, Frankfurt, Hong Kong, London, Luxembourg, Mauritius, Mumbai, San Francisco, São Paulo and Shanghai.  For more information, please visit http://www.warburgpincus.com.

About GTCR
Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Financial Services & Technology, Healthcare, Technology, Media & Telecommunications and Growth Business Services industries. The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth. Since its inception, GTCR has invested more than $12 billion in over 200 companies. For more information, please visit http://www.gtcr.com.

About Nelson Laboratories
Established in 1985, Nelson Laboratories is 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. We call it “The Science of Success®.” 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.

FOR MORE INFORMATION CONTACT:
John Vita
John Steven Vita Communications
847/853-8283
John.Vita@jsvcom.com