Texture Analysis, which has long been used by the
pharmaceutical, food and cosmetic industries, is now increasingly being used to evaluate properties of medical devices.
Texture analysis refers to properties such as firmness, adhesiveness, cohesiveness, tackiness, swelling/absorption, in addition to relaxation behaviour, fatigue and brittleness. For many of these tests, standard methods lag behind product development.
Regulatory agencies including the FDA have used the TA.XTplus Texture Analyser to evaluate medical devices. In addition, the patent literature increasingly relies on texture analysis to validate claims.
Read on for more examples of the application of texture analysis to the future of medical devices...
How is the TA.XTplus typically used in the medical device industry?
There are a myriad of ways to
employ a Texture Analyser in the development and quality control of a medical
device. For example:
• To test membranes and switches, where force/distance/time measurements can be correlated with voltage; for example, many foams and gaskets have impedance characteristics.
• For gel coatings that cure on stents, the cohesion/adhesion and friction properties are measured with the TA.XTplus instrument; the force required to pull a coating off the substrate can be measured.
• For cyclic testing of active implants such as diaphragms and pumps.
• For fatigue tests on a tooth implant post and cap.
• To test membranes and switches, where force/distance/time measurements can be correlated with voltage; for example, many foams and gaskets have impedance characteristics.
• For gel coatings that cure on stents, the cohesion/adhesion and friction properties are measured with the TA.XTplus instrument; the force required to pull a coating off the substrate can be measured.
• For cyclic testing of active implants such as diaphragms and pumps.
• For fatigue tests on a tooth implant post and cap.
For what type of tests does the FDA use the TA.XTplus?
The FDA has the instrument in
several of their labs, including its Division of Pharmaceutical Analysis. They
use it to conduct independent standard and non-standard testing on a variety of
products, and to verify measurements provided by companies. The FDA has
published papers using data for the metered dose inhaler generated with the
TA.XTplus, and it has used it to create tests for evaluating transdermal drug
delivery systems.
Publications and patents:
A recent example of a publication that has used the Texture Analyser in this field is entitled 'Preparation and validation of a skin model for the evaluation of intradermal powder injection devices.' A very promising novel needle-free application method is epidermal powder immunisation, a method delivering particulate vaccines into the viable epidermis of human skin where a dense network of immunocompetent cells resides.
Powder injection devices are being developed, and their evaluation is essential before applying them on live animals and individuals. An appropriate skin model will accelerate the development of such injection devices. Different films made from gelatin, silicon and agar were prepared and investigated as skin model candidates for the evaluation of powder injection devices. The mechanical properties of the skin model candidates were measured with an indentation method using a texture analyser, and the results were compared to the properties of human skin and pig skin.
The indentation behaviour of the model films and the biological skin samples suggest that gelatin films plasticised with glycerol are very well suitable for a skin model. The mechanical properties of gelatin based films can be tailored by changing the glycerol content in the film, making it even possible to simulate human skin with different mechanical properties as the mechanical properties depend on the individual, age, sex and site of injection. Read more: http://1.usa.gov/1x07EgH
To view the thousands of examples of patents that employ the Texture Analyser for the development of medical devices: http://bit.ly/1J5iFAq
We can design and manufacture probes or fixtures for the TA.XTplus texture analyser that are bespoke to your sample and its specific measurement.
Once your measurement is performed, our expertise in its graphical interpretation is unparalleled. Not only can we develop the most suitable and accurate method for the testing of your sample, but we can also prepare analysis procedures that obtain the desired parameters from your curve and drop them into a spreadsheet or report designed around your requirements.
For more information on how to measure texture, please visit the Texture Analysis Properties section on our website.
The TA.XTplus texture analyser is part of a family of texture analysis instruments and equipment from Stable Micro Systems. An extensive portfolio of specialist attachments is
available to measure and analyse the textural properties of a huge range of
food products. Our technical experts
can also custom design instrument fixtures according to individual
specifications.
No-one understands texture analysis like we do!
To discuss your specific test requirements click here...
Publications and patents:
A recent example of a publication that has used the Texture Analyser in this field is entitled 'Preparation and validation of a skin model for the evaluation of intradermal powder injection devices.' A very promising novel needle-free application method is epidermal powder immunisation, a method delivering particulate vaccines into the viable epidermis of human skin where a dense network of immunocompetent cells resides.
Powder injection devices are being developed, and their evaluation is essential before applying them on live animals and individuals. An appropriate skin model will accelerate the development of such injection devices. Different films made from gelatin, silicon and agar were prepared and investigated as skin model candidates for the evaluation of powder injection devices. The mechanical properties of the skin model candidates were measured with an indentation method using a texture analyser, and the results were compared to the properties of human skin and pig skin.
The indentation behaviour of the model films and the biological skin samples suggest that gelatin films plasticised with glycerol are very well suitable for a skin model. The mechanical properties of gelatin based films can be tailored by changing the glycerol content in the film, making it even possible to simulate human skin with different mechanical properties as the mechanical properties depend on the individual, age, sex and site of injection. Read more: http://1.usa.gov/1x07EgH
To view the thousands of examples of patents that employ the Texture Analyser for the development of medical devices: http://bit.ly/1J5iFAq
We can design and manufacture probes or fixtures for the TA.XTplus texture analyser that are bespoke to your sample and its specific measurement.
Once your measurement is performed, our expertise in its graphical interpretation is unparalleled. Not only can we develop the most suitable and accurate method for the testing of your sample, but we can also prepare analysis procedures that obtain the desired parameters from your curve and drop them into a spreadsheet or report designed around your requirements.
For more information on how to measure texture, please visit the Texture Analysis Properties section on our website.
The TA.XTplus texture analyser is part of a family of texture analysis instruments and equipment from Stable Micro Systems. An extensive portfolio of specialist attachments is
available to measure and analyse the textural properties of a huge range of
food products. Our technical experts
can also custom design instrument fixtures according to individual
specifications.No-one understands texture analysis like we do!
To discuss your specific test requirements click here...
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