Emerging Market of Platinum Cured Silicone
Products in Medical Industries
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Silicones have been playing vital role as a part of
product design in medical industries for more than 75 years.
Silicone polymer is having inorganic backbone which is
responsible for its inert behaviour with body tissues and cells. They dont
react with Body Organs and finds most suitable for implant devices.
There are two types of Silicones - Peroxide Silicones and
Platinum Silicones.
Peroxide Silicones are less popular among Polymer
formulation designers for medical industries. Basic limitation of peroxide
silicone is by-products generation during its manufacturing process which
can extract out with contact media. Extract element can deteriorate fluid
properties.
Platinum silicones dont generate any by-products hence
free of any extractable risk which makes it most suitable for medical
applications.
Platinum Silicones are leading in qualifying tests
mentioned under standard ISO 10993 biological evaluations of medical
devices. |
Mr. Vinay Pandey (B- Tech Rubber Technologist)
Ami Polymer Pvt. Ltd. # +91 8691013936
tech@amipolymer.com |
List of Tests under Biological Evaluation of Medical
Devices : ISO 10993 |
Cytotoxicity |
Acute systemic Toxicity |
Genotoxicity |
Sensitization |
Subacute Toxicity |
Hemo- compatibility |
Irritation |
Pyrogenicity |
Implantation |
Platinum silicone easily meets with tests mentioned under Standard
Biological Reactivity test In Vitro USP Class 87 and USP Class 88 (In Vivo).
Having higher shelf life and retains transparency for longer time. Silicones
are useful in various types of Medical Devices as mentioned below : A) Surface
Devices
B) External Communicating Devices
C) Implant Device Platinum Silicone Coatings for Surgical Tools
Platinum Silicone Tubings for Drug Delivery and Surgical Procedure
Silicones Gels are used as soft skin adhesives and wound interface.
Silicone coatings for needles
Silicones Resins for Human Implants
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