TA Instruments and Waters Corporation are pleased to offer a free seminar event featuring mechanical and fatigue characterization, rheological analysis of biomaterials, and analytical testing of extractables and leachables.  The workshop will provide a working knowledge of each technique and examples of applications in medical device testing and characterization.  Attendees will gain practical knowledge of the measurement techniques as well as learn how the featured instrumentation and software may complement and expand their existing laboratory capabilities.

Mechanical Characterization of Biomaterials

The significance of understanding material performance in Biomedical applications can be life-critical and is often instrumental in medical device optimization or tissue mechanics research.  This presentation will introduce a range of applications in which ElectroForce Mechanical Test Instruments are assisting researchers and engineers in gaining a better understanding of native and artificial tissues.  Tissue characterization includes testing to reveal quasi-static and dynamic properties of human or animal model tissues and provide measures to assess drug-, hormone- or age-related changes in tissues such as bone, cartilage, tendon, ligament, vessels, eyes and heart valves.  These properties can also be used as baseline or reference data for medical device development.

Fatigue Characterization of Medical Devices

Durability testing of Medical Devices is crucial for validation of performance and safety and often becomes an important element of regulatory submissions.  As such, devices undergo a range of extensive fatigue characterization to support lifetime predictions for the design, optimization and approval for safe and life-changing device solutions.  A variety of common standards-based test methods will be presented including example or published test data for each.  Finally, a brief instrument demonstration will highlight and reinforce these test examples.

Using Rheology to Characterize Flow and Viscoelastic Properties of Hydrogels, Adhesives and Biopolymers

Rheology is the study of the flow and deformation of matter. In it, we relate stresses and strains for nearly all materials that we encounter in daily life, including biomaterials and biomedical devices. In this talk we will briefly discuss rheology fundamentals and then show applications of these principles to testing biomaterials and biomedical devices. We will discuss the 2 main approaches to rheological testing – unidirectional testing and dynamic oscillatory testing. An example of unidirectional testing is flow testing on fluids to determine their viscosities at various shear rates and temperatures. Other unidirectional tests that are used to determine a materials viscoelasticity are stress relaxation and creep testing will also be mentioned. Most of the presentation will then be devoted to dynamic oscillatory testing, which is the most common way of determining a material’s viscoelasticity. We will describe the different tests that make up dynamic oscillatory testing: dynamic stress and strain sweeps, frequency sweeps, time sweeps, temperature ramps, and temperature/frequency sweeps, and will show the useful information that rheological testing can provide. Some accessories for rheometers will also be described, including tribology fixtures and UV curing.

UNIFI/QTof Screening Workflow for Confirming & Identifying Extractables & Leachables

Characterization of packaging, food contact materials, medical device components and other products is becoming increasingly important due to consumer safety concerns and more stringent global regulations. The initial step in characterizing extractables involves targeted screening, i.e. testing product extracts for known compounds. This is a well-established process and is performed using a variety of analytical techniques ranging from GC-FID-MS to LC-UV-MS.  However, the final product may also contain unknown impurities present in the starting materials or degradants formed during the manufacturing process. Identifying these unknowns is typically a very complex and time-consuming process, requiring significant expertise. The UNIFI/QTof Screening Solution provides a simple workflow for both targeted screening & unknown elucidation. This UPLC, high resolution MS and comprehensive informatics platform aids in the evaluation of complex data by simplifying data review and facilitating the identification of unknown entities.

Registration is free of charge and includes lunch and refreshments.

Tuesday, June 11, 2019

Waters – TA Instruments Regional Office
3540 Howard Way, #100
Costa Mesa, CA 92626

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8:30 AM Registration/Sign-in
9:00 AM UNIFI/QTof Screening Workflow for Confirming and Identifying Extractables and Leachables
Michal Kliman, Ph.D., Technical Support Specialist, Waters Corporation
10:15 AM Break
10:30 AM Mechanical Characterization of Biomaterials
Troy Nickel, Senior Product Manager, TA Instruments
11:30 AM Remote Demonstrations of Mechanical and Fatigue Characterization
Luis Morales, Biomedical Application Specialist, TA Instruments
11:45 AM Lunch
12:45 PM Fatigue Characterization of Medical Devices
Troy Nickel, Senior Product Manager, TA Instruments
1:15 PM Using Rheology to Characterize Flow and Viscoelastic Properties of Hydrogels, Adhesives, and Biopolymers – Part 1
Greg Kamykowski, Ph.D., Rheology Application Specialist, TA Instruments
1:45 PM Break
2:00 PM Using Rheology to Characterize Flow and Viscoelastic Properties of Hydrogels, Adhesives, and Biopolymers – Part 2
Greg Kamykowski, Ph.D., Rheology Application Specialist, TA Instruments
3:00 PM Adjourn

For more information or questions, please contact Steve Hall or Samuel Seal.