Chemistry

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.

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.