A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
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Materials

Emerging Market of Platinum Cured Silicone Products in Medical Industries

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 don’t 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 don’t 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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