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.

Cytotoxicity Failure Program

Cytotoxicity Failures

Cytotoxicity testing is designed to demonstrate if there are cytotoxic leachable substances from medical devices or materials. Cytotoxicity testing is the most sensitive biocompatibility test and is used for safety testing of all medical devices with patient contact.  It is also used frequently as a routine screening test for raw materials.

Occasionally, a device or material will exhibit a level of cytotoxic reactivity that is higher than what is allowed by the ANSI/AAMI/ISO 10993-5 standard and will result in a failed test. Although your product may have failed a cytotoxicity test, it doesn’t necessarily mean that your device or material is unsafe for clinical use. It simply means that you are obligated to identify the source of the failure and assess any toxicological risks. There are several possible causes for a failure, and Nelson Labs provides services to help you assess the failure and any toxicological risks.

Cytotoxicity Failure Program

Reconstructed human epidermis (RHE) for in vitro skin irritation and sensitization testing.

In the past, if your product failed cytotoxicity testing, you would need to send new samples for additional testing to determine the cause of the failure. We have recently added a new service to help our customers potentially save time and money when conducting these evaluations. If you request the Nelson Labs Cytotoxicity Failure Program when submitting your samples to the lab, we will store a sample of the extraction fluid from your cytotoxicity test until you receive your test results. In the case of a failing result, we will connect you with one of our subject matter experts who will help you develop a plan for investigation. Because we have retained a sample extract from your original cytotoxicity test, we can quickly test the retained fluid without the need for a new sample. We typically test for metals in these cases, as the presence of metals from the manufacturing process, handling, or colorants is a primary cause for failed cytotoxicity tests.

If the test detects cytotoxic metals in the extract, we will then contact you with details regarding initiating a toxicological risk assessment. Our toxicologists can assess the metals and determine if the concentration would be sufficient to lead to any patient safety issues. This analysis can also be helpful to decide if an investigation regarding the source of the contamination should be conducted.

The cytotoxicity test is a highly sensitive toxicity assay which is designed to determine if there are cytotoxic leachable substances or surface contaminants present in medical devices or raw materials. It is required testing for most medical devices and is used frequently as a routine screening test for raw materials and cleaning validations.

There are several possible causes for a failure, and Nelson Labs provides services to help you assess the failure and any toxicological risks.

If you would like to discuss this program, contact your Account Manager or sales@nelsonlabs.com.

Sterigenics International LLC Acquires Toxikon’s European Laboratory Business

Acquisition creates the leading global extractables and leachables lab testing platform to serve the pharmaceutical and medical device industries

CLEVELAND, OH. – Oct. 31, 2017—Sterigenics International LLC announced today that it has acquired Toxikon Europe N.V., the European division of Toxikon Corporation, a Bedford, Mass.-based preclinical contract research organization. Terms of the deal were not disclosed.

Toxikon Europe N.V. provides a suite of integrated analytical, material characterization and microbiological services to the pharmaceutical, medical device and biologics industries. The company’s unrivaled extractables and leachables (E&L) testing expertise and leading database enhance the flexibility and speed with which its life science customers can bring their products to market.

This acquisition provides a more comprehensive service offering and a platform for growth for Sterigenics International’s Nelson Labs business. Nelson Labs will now offer Toxikon Europe’s leading E&L capabilities to its customers around the world and in kind, offer Nelson Labs leading microbiological services to Toxikon Europe’s customers.

“Toxikon Europe’s geographic foothold and expert analytical testing platform enable our global expansion and ability to provide significantly greater value to customers,” said Michael B. Petras Jr., CEO of Sterigenics International. “We are excited to welcome a strong management team, with over 150 years of aggregate industry experience, and the highly trained Toxikon Europe employees to our company.”

Toxikon Europe’s capabilities are both complementary and additive to Nelson Labs’ existing testing portfolio and, in combination, make Nelson Labs one of the premiere global E&L laboratory testing platforms for the pharmaceutical and medical device industries.

As part of this deal, Nelson Labs and Toxikon USA will enter into a long-term supply arrangement under which Nelson Labs will outsource in-vivo biocompatibility to Toxikon USA.

“The acquisition of Toxikon Europe and our ongoing partnership with Toxikon USA support our strategy to offer greater breadth of services to meet the demands of our rapidly growing, global customer base,” said Jeff Nelson, President of Nelson Labs. “We are now able to serve the pharmaceutical and medical device industries continuously from the early stages of product development through manufacturing, sterilization, and quality assurance testing.”

“For Toxikon Europe, the acquisition by Sterigenics International validates our success and provides our customers with additional resources,” said Dr. Laxman Desai, President and CEO, Toxikon Corporation. “Our team at Toxikon USA looks forward to our continued partnership with Nelson Labs.”

Jos Bollen, Managing Director, Toxikon Europe, added, “Our customers, who are increasingly focused on quality and safety, will continue to receive the superior service and quality they have come to know from Toxikon Europe. In addition, our breadth of service and our reach will be enhanced with the expertise and industry leadership of Sterigenics International’s Nelson Labs.”

About Sterigenics International LLC
Sterigenics International LLC, along with its affiliates, is the world’s leading, fully integrated protector of global health.  With over 500 years of combined scientific expertise, the company ensures the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue and food industries.  Sterigenics International operates 60 facilities in 13 countries across the Americas, Europe and Asia.  The company has 2,600 employees globally and touches the lives of more than 180 million people around the world each year.  With more than 6,000 customers worldwide, Sterigenics International goes to market through its three best-in-class companies – Nelson Labs, Nordion and Sterigenics – with the mission of ensuring the safety of healthcare each and every day.  Nelson Labs offers leading microbiological and analytical testing and consultancy to customers in the medical device, tissue/implantable, pharmaceutical and biologics fields.  Nordion is 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 provides contract sterilization and ionization services for the medical device, pharmaceutical, food safety, and high-performance materials industries.  Sterigenics International LLC 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 Toxikon Europe N.V.
Toxikon Europe is an independent, privately owned Contract Research Organization, specialized in providing premium Extractable & Leachable Services to the Pharmaceutical Industry. Based in Belgium, Toxikon Europe supports Pharma Companies – across the Globe – in developing worldwide compliant
(FDA, EMA) Testing Strategies to qualify Container/Closure Applications and Pharmaceutical Production Equipment from an Extractable & Leachable Perspective. In addition, the Toxikon group also provides Biocompatibility Testing Services (In-Vivo and In-Vitro testing) to both the Medical Device and the pharmaceutical Industries. Toxikon is ISO 17025 Accredited, GLP-Certified and GMP Accredited. Toxikon is also FDA registered.

Media Contacts:
Sterigenics International – Amy McGahan, 216-241-3027, amcgahan@dix-eaton.com
Toxikon Europe N.V. – Jos Bollen, 32 16 400484, Jos.Bollen@toxikon.be
Toxikon USA – Branden Morris, 781-275-3330 X 7141, branden.morris@toxikon.com

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.

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