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Cochlear Implant

NuSil silicones help create connections between the human brain and life's most delicate, most important moments. Life-changing applications such as cochlear implants rely on our medical-grade silicones for the highest level of purity.

Life Sciences

Overview

The Most Extreme Environments. The Purest Solutions.

NuSil Technology, the global leader in medical-grade silicones, brings over 30 years of success in developing products for the most extreme environments, from deep inside the human body to the harsh conditions of outer space.

Supported by our high-touch approach to customer care, our best-in-class product lines are the choice across the drug delivery, medical implants, general healthcare and skin care industries.

Let us show you how we're transforming the science of silicone into the Chemistry of Care™.


Purity

The extreme conditions inside the human body are as demanding as those of outer space. To create success in these environments, we look beyond standard methods.

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We’ve incorporated controls to remove impurities at every step in the manufacturing process. We carefully select our raw materials and custom make equipment that produces the most refined intermediates and the purest finished products.

And we complete this with our Proprietary Purification Technology, purpose-built to produce silicones with the lowest volatility levels.

The result is our Medical Grade Ecosystem, which creates the purest silicones in the industry.

NuSil Care

High-risk industries demand a higher level of care. Over decades, we’ve refined our support systems to meet the high-touch needs of our customers, delivering support throughout the entire commercialization process.

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Where many raw material suppliers have transitioned to primarily web-based service models, we’re always available to talk with you personally, when others typically won’t.

This face-to-face service model delivers support throughout the entire commercialization process, from product design to launch and approval. And our global regulatory expertise and experience with international agencies (including FDA, EMEA and CFDA), is seamlessly integrated to ensure that you are in compliance.

Our customer care practices have led to numerous supplier awards and—more importantly—the trust and distinction of being sole sourced for many of our customers.

What is Medical Grade?

Medical-grade silicones are specifically designed, manufactured and purified to meet the strictest needs of the healthcare industry.

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Though there is no uniform definition, as the global leader in silicones for the healthcare industry, NuSil defines medical grade in the following manner:

How it’s made:

●     Raw materials, intermediates, and finished products are manufactured with applicable GMP and/or appropriate regulatory standards

                        - cGMP 21 CFR § 820 – Device

                        - cGMP 21 CFR § 210-211 – Drug/API

- ISO 9001

●     Open to facility audits by customers

 

How it’s supported: (Based on NQSTM)

●     Indirectly or directly regulated by U.S. FDA

●     Regulatory support: DMF, MAF, CEP

●     Communicate end use with regulatory authorities

 

Intended use:

Medical materials only: all to be used in the body, on the body, or in contact with the body (designed, manufactured, and supported specifically for medical use)

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