E&L

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