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.

Nelson Labs at Utah STEM Fest

STEM Fest blog 100317

Nelson Laboratories’ Women in STEM Education (WISE) Committee is exhibiting for the third year in a row at the Utah STEM Fest. The Wise Committee is partnering with Junior Achievement of Utah to bring hands-on activities that will surely spark students’ interest in science and science careers.

The Nelson Labs booth will have hands-on activities and fun giveaways for students. Activities include a bullseye micropipette game, a nitinol wire demonstration, a microorganism matching game, microscopes to view microorganisms, and a life-size skeleton equipped with real medical devices.

“The booth aims to engage students by highlighting scientific techniques used every day by the global experts at Nelson Laboratories,” said WISE Committee Co-Chair and Senior Director of Laboratory Operations, Tina May. “This is our 3rd year exhibiting at the Utah STEM Fest, and we love the opportunity to connect with students and encourage them to consider the life sciences when choosing their career.”

STEM Fest is held on October 3 & 4 from 9:00 am – 4:00 pm at South Towne Expo Center in Sandy, UT.  The event is for 5th-10th grade students; it is also open to the general public from 2:00-8:00 pm on Tuesday, October 3. Nelson Laboratories’ booth is #321.

The WISE committee is comprised of 17 women scientists and leaders at Nelson Laboratories who are committed to bringing the passion for STEM careers to youths of all ages.

Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.

As the needs of our customers have evolved, we have continuously updated our seminars to meet those changing needs.  To better align with the new, more comprehensive agenda, Nelson Labs is re-naming the seminar to: Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing. The program will continue to be RAPS and ASQ approved for 12 RAC and 1.2 ASQ credit hours and may also qualify for AAMI credit hours. Courses are taught by Nelson Labs’  and SteriPro’s scientific experts. Highlights include, but are not limited to:

  • Introduction to Microbiology & Sterilization:
    The introduction offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important industry terms.
  • Ethylene Oxide Sterilization Validation:
    Learn how to develop, optimize, and validate a successful ethylene oxide sterilization process that delivers the necessary sterility assurance level and ensures repeatability.
  • Biocompatibility / ISO 10993:
    With 24 possible categories, the biocompatibility testing experience can be intimidating. We will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.
  • Chemical Characterization / E&L Assessments:
    This topic will help you understand the analytical chemistry strategies that can be used to characterize device materials and evaluate extractable/leachable compounds.
  • Packaging Overview / ISO 11607:
    Focused on the requirements outlined in ISO 11607, this subject will help you understand packaging validations and how to successfully navigate the package testing arena.
  • Radiation Sterilization Validation:
    Attendees will learn how to perform radiation validations, review bioburden data, deal with sterility test failures, and understand the various radiation options (gamma, electron beam, and X-ray).
  • Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices:
    Our experts will teach attendees the information and processes involved in the validation of healthcare device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria.
  • Cleaning Validations for Newly Manufactured Devices and Single Use Implants:
    The importance of manufacturing clean devices will be discussed, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.

The full seminar is appropriate for professionals who are new in their role as well as for MedTech veterans. Lectures are presented by industry-leading experts and include case studies, hands-on activities, Q&A, and one-on-one time with the speakers. 100% of post-seminar survey respondents have expressed that they would recommend the seminar to a colleague or friend.

Visit the Seminar page on the Nelson Labs’ website to learn more about the next seminar near you.

For more information regarding our seminars, contact the Nelson Labs’ marketing department: marketing@nelsonlabs.com.

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs.

The experts at Nelson Labs are teaming with MD+DI to bring a live three-day webinar event that provides manufacturers of medical devices and pharmaceutical products with the most up-to-date regulatory updates, trends, and anticipated changes (including FDA, ISO, USP, and MDRs). Online registration is currently available on the MD+DI website. Many of those speaking contribute to committees that provide global guidance to safeguard patient health; each webinar will offer 15 minutes for audience questions with these experts. Details for each webinar are as follows:

OVERVIEW DAY 1

Title: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes

Date: Tuesday, 26 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The presentation will include:

  • Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
  • Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
  • An overview of changes that are expected with the acceptance of in-vitro irritation testing.
  • A thorough review of the impact of the recently finalized ISO 18562 standard which specifically targets respiratory contact devices.

Presenters:

Thor Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting

Matthew R. Jorgensen, PhD
Chemical and Materials Scientist

OVERVIEW DAY 2

Title: Sterilization Methodologies and Packaging Integrity Testing: Updates, Trends, and Anticipated Changes

Date: Wednesday, 27 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:
Sterilization methodologies and packaging integrity testing are necessary to ensure patient safety. The sterilization portion of the webinar series discusses recent and upcoming changes to regulatory documents and standards such as:

  • Changes that impact steam, radiation, hydrogen peroxide, and ethylene oxide sterilization modalities.
  • What to expect in the new ISO document for hydrogen peroxide sterilization.

As part of the packaging presentation key points regarding the new European MDRs will be reviewed, including:

  • How medical device manufacturers can collect and document objective evidence of compliance for their packaging, look at designs that prevent microbial contamination at the point of use, and justify that the package is suitable for current use.
  • An introduction to a new leak-testing technology, Mass Extraction, that demonstrates container closure integrity in a non-destructive and rapid manner, will be presented. This new test meets the deterministic requirements as outlined in the newly published USP chapter 1207.

Presenters:

Martell K. Winters, B.S., SM (NRCM)
Director, Scientific Competency

Jason Pope, B.S., ASQ CQA
Senior Scientist

Wendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader

OVERVIEW DAY 3

Title: Cleanliness Testing for Medical Devices: Updates and Trends

Date: Thursday, 28 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will cover the latest updates and current trends for medical device cleanliness testing. This webinar will include:

  • A review of the upcoming and highly anticipated orthopedic implant cleanliness ISO document.
  • A discussion about the testing considerations for certain additive manufacturing processes.
  • Guidance updates for reusable device validations.
  • An update regarding the reprocessing of single-use devices.

Presenters:

Alpa Patel, B.S., RM (NRCM)
Senior Scientist

Alexa Tatarian
Study Director III

Paul L. Littley, B.S.E
Consulting Manager

FTIR in Assessment of Medical Devices

By: Adam B. Brigham, B.S.; Matthew R Jorgensen, PhD

Fourier transform infrared (FTIR) analysis is a popular analytical tool for material screening. The technique works because each different type of molecular bond in a molecule vibrates differently, and there is often a set of molecular vibrations that involve the entire molecule that form a characteristic “fingerprint.” When measuring a molecular substance, it is possible to identify an organic substance by comparing its FTIR spectrum to a library. In cases where a substance is a mixture of molecular components, FTIR would not be the best option because a separation technique (e.g. chromatography) would need to take place before identification could occur. However, there are many cases for which FTIR analysis is a fast and inexpensive option.

FTIR can be a useful first step as an aid in the identification of an unknown residue. Even if an exact identification is not possible (e.g. in the case of mixed residue), FTIR can often help identify the class of compound which can assist in unknown investigations or process monitoring. For example, if high residual manufacturing material was found on a device, FTIR could be used as an investigational tool to help identify the source. If FTIR was unable to find a conclusive library comparison match, additional testing would need to take place.

FTIR shines when comparing two or more materials in-hand. For example, when particulates are found on a device, it may be necessary to attempt particle identification so that the source can be found and eliminated. Other analytical chemistry techniques would fail at this task, because the amount of particulate material is too small to analyze. FTIR can be conducted through a microscope so that the “fingerprint” of a single particle can be collected. This spectrum can be compared against potential contaminants (e.g. paper, fibers from clothing, or materials unique to the device manufacture), or a library of materials which can greatly narrow the possibilities.

There are also cases where the question being asked is, “does a certain process change my material?” FTIR is a great resource for polymer characterization. Depending on the nature of the material and process, it may be possible to pinpoint what the change is. For example, oxidation of a polymer is clearly indicated by the introduction of carbon-carbon double bonds. If the details of the change are not derivable, it can at least detect if a change has occurred. Perhaps a manufacturer considers changing the radiation dose for their material; they can measure the original device and a device irradiated at the new level comparatively to see if anything is different.

Any FTIR study relevant to medical devices should be carefully thought through and designed with expertise. Simply ordering of a single test without a specific objective in mind will be marginally useful. With smart design – powerful conclusions can be made.

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.