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

AAMI Sterilization Standards Meetings Update

By: Emily Mitzel, MS

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance.

One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance (OC), and Office of Surveillance and Biometrics (OSB) are merging into a single structure specified as the Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC).

A second item of interest is the Accreditation Scheme for Conformity Assessment (ASCA) in which FDA is ensuring testing laboratories are consistent and are complying with current standards. https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm558632.htm

Medical Device Reprocessing Update:

  • AAMI TIR30:2011 Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices is in the process of review and is being rewritten.
  • ISO/FDIS 17664 – Sterilization of Medical Devices Information to be provided by the device manufacturer for the processing of reusable medical devices last published in 2004 will be publishing a new version (hopefully by the end of 2017).
  • A new document currently titled ISO/NP 22913, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Medical devices not intended for direct patient contact, was approved and will be written.
  • The current draft of ISO 15883-5 – Test soils and methods for demonstrating cleaning efficacy is undergoing a major revision.

The dates of the next AAMI Sterilization Standards meetings are:
19-22 March, 2018
22-25 October, 2018

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

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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.