Silicone rubber, an elastomer comprised of silicone, a polymer consisting of silicon, carbon, hydrogen, and oxygen, finds extensive usage across various industries. Numerous formulations of silicone rubber are available to cater to diverse industrial needs. Silicone rubber undergoes a curing or vulcanization process to transform it from a liquid or gel state into a solid form.

This curing process enhances the resilience of silicone rubber, imparting exceptional resistance to both high and low temperatures. Uncured silicone rubber has the tendency to deform when exposed to heat and can become brittle when subjected to cold temperatures.

The most common way of curing is platinum-catalyzed cure system, a condensation cure system, a peroxide cure system, or an oxime cure system. Platinum- Catalyzed curing is acknowledged as best curing of Silicone for Medical Application because it’s biocompatible, doesn’t tarnish, and is not rejected by the body. On other hand Peroxide curing system does result in byproducts, which tend to be volatile organic acids.

 How is Silicone defined as Medical Grade Silicone?

Silicone which is tested with Biocompatibility and approved under USP Class V & USP Class VI are considered as Medical Grade Silicone as per Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).

Categories:

Medical Grade Silicone are grouped into three Categories: Non- Implantable, Short Term Implantable and Long Term Implantable

Non-Implantable Grade Silicone:

Non-Implantable Grade Silicone is also a Class VI Silicone tested with Biocompatibility and it’s safe to come into contact with human skin, transferring of Blood and body fluid via Tubing outside the human body, but it cannot be implantable inside the body for more than 24 Hours

Application of Non-Implant Grade Silicone: –

Application in which the product is in contact with Blood or body fluid but the product is not Implantable in body for more than 24 Hours such as: –

Menstrual Cup, Baby Nipples, Baby Feeding Cup, Tubing for Diagnostic & Analyzer machine, Kegel Ball, Reusable Phacosleeve, Reusable Breathing Tube, Seals & Gaskets.

While it’s widely acknowledged that silicone is the ideal material for medical applications, the challenge lies in selecting the most suitable grade for your specific needs!!!

Short Term Implantable Grade Silicone:

Short Term Implant Grade Silicone have very sensitive requirements to avoid interacting with tissue. The material is manufactured in very strict environment considering the tolerance limit of extractable. The product is tested with Biocompatibility and Implant test for Less than 29 days Implant.

Application of Short-Term Implant Grade Silicone: 

Application in which the product is in contact with Blood or body fluid and Implantable in body for more than 24 Hours upto 29 Days such as: –

Wound Drain Catheter, Nasal Splint, Catheter used for less than 29 days Implant, Vessel Loops, Implant tubing for Dialysis purpose

Long Term Implantable Grade Silicone:

Long Term Implant Grade Silicone have very sensitive requirements to avoid interacting with tissue. The material is manufactured in very strict environment considering the tolerance limit of extractable. The product is tested with Biocompatibility and Implant test for more than 29 days Implant.

Application of Long-Term Implant Grade Silicone:

Application in which the product is in contact with Blood or body fluid and Implantable in body for more than 29 Days such as: –

Hemodialysis Catheter, Silicone Breast, Gastric Bands, Tear Duct, Heart Pump Component, Scleral Buckle

Ami’s portfolio of Silicone product:

Ami Polymer has specialized in polymer products catering to various sectors including Infusion therapy, Diagnostic, Cardiac, Gastroenterological, Ophthalmic, and Gynaecological fields. Our range includes Menstrual Cups, Breathing Tubes, PEG Tubes, Reusable Phaco Sleeves, Needle-free connectors, Medical Grade Tubing, Baby Feeding Cups, Haemodialysis Catheters, and Wound Drain Catheters. These are manufactured in our Class 10000 Clean Room facility, registered with USFDA and CDSCO, and certified with ISO 13485, ISO 9001, ISO 45001, ISO 14001, and ISO 27001.

Equipped with Implant grade material resource, in-house CNC & VMC machines and a dedicated development team, we offer tailored solutions to Medical and Healthcare professional and Industries. Overall, Ami Polymer’s product portfolio in the medical sector offers a wide range of polymer-based solutions for various medical applications, ensuring quality and safety in the medical industry.

Authored By:

Anuj Singh

Deputy Manager – Global Healthcare Division

Ami Polymer Pvt Ltd