Biological Evaluation of Medical Devices This application note answers some frequently asked biological evaluation questions, including: How Do I Address Biological Risk in My Medical Device? If My Manufacturing Process Changed, Do I Need to Redo My Biocompatibility Testing? Should I Prepare the Biological Evaluation Plan (BEP) In-House or Use a Consultant?
Chemical Characterization of Medical Devices: Seismic Shifts in ISO10993-18:2020 January 2020 brought a new and transformative revision of ISO 10993-18, the principle standard governing chemical characterization of medical devices. Coming 15 years since the last published revision, the standard dramatically transforms the scope of the chemical characterization workflow.
CMR & ED Testing for EU Medical Device Regulation (EU MDR) This application note covers a subset of EU MDR changes and describes screening of medical devices or medical device components for two specific families of compounds, namely diisocyanates and phthalates.
Developing a Custom Hydrogel for Realistic Electrosurgical Training This application note discusses the development of "e-tissue," a custom hydrogel designed to simulate the behavior of natural tissue during electrosurgical procedures. Addressing ethical concerns related to animal testing, e-tissue offers a stable alternative that chars and produces smoke under bipolar and monopolar electrocautery, closely mimicking real tissue responses. This material enhances surgical training by providing realistic tactile feedback and supports medical device developers in creating effective training tools.
Development of a Carpet Treatment This application note details the development of a sprayable carpet treatment designed to refresh faded carpets. The project involved formulating a product that adheres to various carpet fibers, including older and soiled ones, while ensuring durability against foot traffic and consumer safety. Efforts focused on material formulation and testing methods, conducting a design of experiment study to streamline testing. Custom screening tests were developed for wettability and durability due to the lack of standard methods. Ultimately, formulations that demonstrated good sprayability and effective coverage on nylon, polypropylene, and PET were selected, resulting in three formulations that met the client's criteria and were prepared for consumer testing, along with validated methods for future assessments.
Did Your Biocompatibility Study Fail? Trace Level Analysis to the Rescue When your meticulously designed medical device unexpectedly fails a cytotoxicity test, the initial reaction might be one of concern. However, all is not lost. The key to resolving this issue often lies in trace level analysis, which can identify minute contaminants responsible for the failure. By examining the test media from the failed cytotoxicity assessment and tracing these findings back to the bill of materials and processing aids, the root cause can often be pinpointed. This approach not only helps in identifying potentially harmful compounds but also assesses whether these compounds pose a genuine toxicological risk. If deemed non-threatening, this information can justify the release of the product. This case study highlights the use of advanced techniques such as gas chromatography mass spectrometry and liquid chromatography quadrupole time-of-flight mass spectrometry to uncover hidden contaminants, ultimately allowing for informed decision-making regarding product safety and release.
Material Science in ISO 10993-18 Testing This application note discusses some of the complexities of ISO 10993-18, and how an understanding of material science plays an important role in data interpretation.
Packaging for Medical Devices and Pharma This application note discusses crucial aspects of packaging design for medical devices and pharmaceuticals, highlighting the importance of material selection and thorough testing to ensure compliance with regulatory standards. Key considerations include barrier properties against oxygen, moisture, and light, as well as sterilization compatibility, biocompatibility, and user interface. Ethylene vinyl alcohol (EVOH) is noted for its excellent oxygen barrier properties, although it requires multi-layer packaging to address moisture sensitivity. The note outlines various testing methods, such as FTIR and DSC, to analyze packaging materials and ensure they meet sterilization requirements. Additionally, it underscores the significance of accelerated aging methods to predict shelf life and maintain packaging integrity.
Profiling Scotch Whisky CPG uses Gas Chromatography-Mass Spectrometry (GC-MS) and Head Space Gas Chromatography (HS-GC-MS) to profile a small selection of malt whisky samples from various regions of Scotland and aged over a range of years in casks (or multiple casks).
Pyrolysis GCMS of Adhesives This case study investigates the use of pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS) to analyze two silicone adhesives with differing adhesion qualities. Based on the resultant degradants (cyclic versus linear siloxanes), the analysis revealed that the adhesive with good adhesion was structurally different from the one with poor adhesion. These structural differences suggest a link between molecular composition and adhesion performance, demonstrating the effectiveness of Py-GC-MS in analyzing complex polymeric materials that are challenging to evaluate with traditional methods.
Yield Strength Rheometry This application note examines yield stress, highlighting its importance in determining when materials begin to deform or flow. Yield stress is crucial for products like hair gels and adhesives, which must maintain shape until a specific force is applied. It outlines two methods for measuring yield stress: applying an increasing force and using a steady shear rate. The note emphasizes selecting appropriate testing methods based on the material's application.