Medical Grade Silicone
Medical Grade Silicone
Medical Grade Silicone OEM & Medical Silicone Molding Service
ISO9001:2015 | FDA | COC | CPC | SGS | BSCI | CE | ROHS
Customized Medical Silicone Solutions for You
As one of the important links in the medical device production chain, Newtop Medical Silicone has long been committed to manufacturing high-quality complex medical-grade silicone parts (Class I and Class II medical devices) for customers with a highly responsible attitude.
But we are not just manufacturing parts, our core concern is to solve problems for customers and realize their ideas. At Newtop, what you will get is a one-stop customized silicone solution. We will listen to your needs and work with You to establish a stable and healthy cooperative relationship and provide you with long-term high-quality services.
We apply decades of experience in the field of medical silicone molding and a large amount of professional manufacturing knowledge to the entire life cycle of your product development, thereby reducing the risks you may encounter and maximizing your business benefits. At the same time, the Newtop team is well aware of the importance of the medical industry and upholds the spirit of reverence for life to create more value for society.
Step1: Products Design
Newtop provides material selection guides, cost estimates, and technical advisory services, all of which are provided free of charge. If you just want to solve some doubts, we are also more than happy to help you.
All you need to do is to get in touch with us and indicate your needs, it should include the product’s name, specific function, or ideas, drawings, samples.
We will communicate about your needs. Newtop designers build digital models with CAD software tools so that you can see the product more clearly. In addition, engineers will advise you on material selection and fabrication.
All of this work is to ensure that your requirements are manufacturable and cost-effective.
Step2: Silicone Prototyping
Newtop uses an efficient in-house silicone mold shop to create prototype molds for you. You can fully rely on our customizable mold development capabilities and precision tooling technology.
Newtop’s tooling process includes CNC & EDM, and the manufacturing material is mainly aluminum or anodized steel. Our tooling is adjustable to a certain extent, which allows you to flexibly create and modify your products.
During the prototyping stage, your needs may change all the time, and we will respond effectively. According to the specific situation, we will choose the most suitable process and materials for you.
Step3: Mass Production
At Newtop, we provide a variety of molding methods with different characteristics for you to choose from. The most common are compression molding, injection molding, over-molding, etc. Our engineers will assist you to determine the production plan.
With the support of our automated high-speed silicone molding line, your product will be able to be manufactured in tens of thousands.
Step4: Post-Processing
If you want your product to have a unique logo or packaging to improve the impression of your product, Newtop can help you achieve this.
You can print any pattern on your product. It can be textured, screen printing, pad printing, laser engraving or other forms.
We also provide professional packaging design and manufacturing solutions to meet your individual needs.
Step5: Quality Control
Newtop believes that medical product quality is an important reflection of our service level. We guarantee that all quality problems will be eliminated before leaving the factory.
We produce in accordance with ISO 13485:2016 standard. All batches of products will undergo strict sampling inspection. The precision of the parting line of the product is within 0.05mm, and the conformance rate can reach more than 99.8%.
According to the quality requirements of the product, we are also able to do other processing such as post-curing and cutting.
Medical Silicone Application
- General medical parts such as o-rings, gaskets, seals, and diaphragms
- Dialysis bag caps, valves, transfer set, and seals
- Pharmaceutical: Septa disks and incubator
- Respiratory and surgical masks
- Gastroenterology: Feeding devices, balloons, and medical tubing
- Dental impression molds, Orthopedics, and prosthetics parts
- Ventilation masks, rubber parts, and tubing
- Dosage Control Devices, catheters, fluid, and drug delivery systems
- Vascular: Hemostasis valves and accessories
Medical Grade Silicone Rubber
The medical parts market has been in high demand for materials that can perform stably in specific environments. This demand essentially stems from the particularity of the medical industry. When medical equipment doesn’t function properly, the consequences can be catastrophic. Patients may harm their health or even threaten their lives due to the wrong choice of materials for the equipment. Therefore, medical parts and components have always been synonymous with high requirements and high standards. At the same time, they also help point the way for the development of materials for the medical industry. After a lot of practice and market verification, LSR (Liquid Silicone Rubber) stands out and has won a lot of recognition from doctors and patients.
As early as the 1950s, liquid silicone rubber began to be used as clinical human implants. The material has been found to have excellent stability and water resistance, is soft and elastic, and has a texture similar to that of skin.
From a material science point of view, silicone rubber is a thermoset material, which is stored in a liquid state, injected into a mold through a pipe during processing, and cured by high temperature treatment. Once cured, LSR maintains a stable cured form, which is a desirable property in the medical industry.
Because silicone rubber is in a liquid state prior to curing and has a very low viscosity, it is injected into the mold with virtually no voids. This means that the structural strength of the finished silicone rubber medical part after curing can be achieved to a satisfactory level.
- High biocompatibility
The first question that all materials will face in the medical industry is – is it safe enough for the human body? LSR gave us a positive answer. silicone rubber is an inert material that, under normal circumstances, undergoes little mass exchange with what is in the environment. LSR has been clinically proven to be sufficiently safe in long-term human exposure and does not cause allergic or other irritating reactions. From this, we were able to realize the two advantages of LSR as a medical silicone rubber, that is, it is not affected by the environment and does not affect the environment.
- High temperature resistance
Another important factor that doctors will consider is the resistance of the material to the sterile environment. As we all know, sterility is a basic premise that all medical products, including reusable and single-use, must have. If we only focus on ordinary plastic materials, we will find that they are difficult to adapt to high temperature sterilization environment and chemical exposure, that is to say, they will be eliminated in the disinfection stage like bacteria. But LSR can meet this challenge. LSR can withstand high temperatures from -50°C to +250°C and exhibits strong stability to most chemicals. LSR can be regarded as an ideal material for making medical silicone parts.
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