Silicone, as an indispensable material, has been widely used in various aspects of life. But not all silicone products have the same quality. Here, we will introduce three different silicone grades for you in detail. This will help you choose the most suitable silicone for your business.
Three Different Grades Of Silicone
Industrial Grade Silicone
Industrial silicone is a type of silicone specifically designed for industrial production environments.
It is strictly prohibited to be used in scenarios such as food, maternal and infant care, where it comes into close contact with the human body or food. Because this silicone does not meet the safety contact standards, it will cause certain harm to the human body.
If you are in the industrial field, please make sure to avoid using them to manufacture medical equipment or food utensils.
Advantages of Industrial Grade Silicone
The greatest advantage of industrial silicone is that its price is much lower. Generally speaking, its price is 30% to 50% lower than that of food-grade silicone and over 60% lower than that of medical-grade silicone. Therefore, if you need to apply silicone in fields where purity requirements are not high, it is definitely the most cost-effective choice for you.
In addition, it is extremely flexible and can be customized to your requirements. Whether you need to produce soft sealing gaskets or hard insulating parts, it can meet your needs.
Moreover, it can usually bear temperatures from-58°F to 392°F(-50℃ to 200℃), and some special models can even withstand higher or lower temperatures. Besides, with its excellent aging resistance and insulation properties, your products can adapt to a wide variety of complex industrial environments.
Disadvantages of Industrial Grade Silicone
Firstly, its purity is relatively low, and the manufacturing process is poor. Therefore, if you are in the fields of food, mother and baby products, etc., you must avoid using it.
Secondly, industrial-grade silicone is more prone to degradation in environments such as ultraviolet rays and chemical substances. This will significantly shorten the service life of your products.
In addition, some special industrial-grade silicone may extend your delivery time. You need to plan the inventory in advance.
Applications of Industrial Grade Silicone
If you are in the mechanical manufacturing industry, please prioritize choosing industrial-grade silicone. They can be used to make O-rings, gaskets, shock-absorbing pads, etc., for industrial equipment. It can easily meet your high requirements for wear resistance, high elasticity, and shock absorption.
In addition, it can also be applied to the manufacturing of automotive parts. If you are looking for a material for sealing components around the engine of an automobile, you can choose industrial silicone. Because it is resistant to high temperature and oil, it can ensure your products meet the standards of the automotive industry.
Meanwhile, it has excellent insulation properties. When you are choosing silicone sheets for wire and cable insulation layers or electronic component fasteners, etc., it is your ideal material.
Food-Grade Silicone
Food-grade silicone is a type of silicone made from high-purity raw materials and meets the requirements of food contact safety standards. It is non-toxic, odorless, and ensures user safety. Therefore, it is widely used in the fields of mother and baby care, kitchen utensils, etc.
Advantages of Food-Grade Silicone
You don’t have to worry about the release of harmful substances because it’s BPA-free and plasticizer-free. Even if they are exposed to food or the human body for a long time, it will not harm the health of your clients.
Meanwhile, it feels extremely soft and can deform freely and rebound quickly. Therefore, whether you want to customize pacifiers or baking pads, etc., it can meet your ordering needs.
And it’s durable, so you don’t need to worry about it aging quickly or breaking easily.
After use, food-grade silicone needs to undergo high-temperature sterilization. Whether it is hand-washing or machine-washing, it can withstand hot water or high-temperature steam sterilization, etc. Moreover, during this process, it will not soften, making your silicone products more durable.
Disadvantages of Food-Grade Silicone
For instance, it is more expensive than other food contact materials such as plastic and metal. And after being used for a long time, food-grade silicone may change color or develop an unpleasant odor, and it needs to be replaced regularly. As a result, your purchase cost will be higher.
Certifications of Food-Grade Silicone
To ensure that your silicone products are indeed of food-grade quality, you need to have relevant medical-grade silicone certification.
FDA: If you want to enter the US market, you need to have the corresponding FDA certificate. Please ensure that your orders and sales will not be affected due to the lack of certificates.
LFGB or EU 10/2011: If your target market is the EU, you need to check whether you have LFGB or EU 10/2011. Such certificates are often of higher quality than those of the FDA and can help you better enter the high-end market.
Applications of Food-Grade Silicone
Food-grade silicone, due to its durability and other characteristics, has become an ideal material for food contact applications.
It is widely used in areas such as mother and baby products, kitchen baking, water appliances, and household electronics.
If you belong to the field where silicone needs to directly contact food and human bodies, choosing food-grade silicone will be your wisest choice.
Medical Grade Silicone
As a wholesaler, you need to know that medical silicone is the highest-quality and most valuable type of silicone. It is a high-purity and highly biocompatible silicone specifically designed and manufactured for medical applications. This means it contains no pollutants and will not cause any irritation or harm to living tissues.
Advantages of Medical Grade Silicone
The most obvious feature of medical silicone is its biocompatibility. In simpler terms, it is harmless to the human body. As long as you use compliant medical silicone, when it’s exposed to human skin, etc, there will be no allergy or other adverse reactions.
Secondly, it can be adapted to various sterilization methods such as ethylene oxide and steam disinfection. Therefore, you don’t need to worry that after sterilization, it will deform or release harmful substances.
Disadvantages of Medical Grade Silicone
Of course, it is precisely because medical silicone has a higher purity and a more rigorous manufacturing process that you need to spend the highest procurement cost.
Meanwhile, medical-grade silicone may gradually age, and you need to repurchase it regularly.
Certifications of Medical Grade Silicone
You must carefully examine its qualification certificate. Because if there is any fraud involved, you will face extremely high penalties. This will undoubtedly harm your business interests.
USP Class VI: It is the core certification for medical-grade silicone. Especially for implant-level products, you must ensure that they pass this certification.
ISO 10993: It is to prove that your product meets international biocompatibility standards. This is the basic requirement for you and your medical clients when making purchases.
Applications of Medical Grade Silicone
Although medical-grade silicone is obviously silicone suitable for the medical field, it can still be subdivided.
For external medical devices, you can use them to make breathing masks, urinary catheters, medical gaskets, and other items.
If you are a company that sells implantable devices, you can apply it to artificial joint gaskets, breast augmentation prostheses, etc. For this type of medical silicone, since it needs to avoid rejection by the human body, you must have the highest level of medical certification.
As for the fields of pharmaceuticals and medical equipment, you only need to purchase silicone pads for sealing parts used in drug production lines or ventilator sealing pads, etc. You need to make sure that it can be sterilized and that no toxins are released.
How To Choose The Right Silicone Grade For Your Business?
Application industry: You need to consider the specific application scenarios of the product. For instance, if it is for medical devices, you need to use medical silicone that meets biocompatibility standards.
Environmental conditions: You need to evaluate the environment to which the product will be exposed. For example, if you need to buy sealing accessories near car engines, the silicone must be resistant to high temperatures and oil.
Reputable Suppliers: Choosing reputable partners is essential to ensure that the silicone you purchase for wholesale does not have quality issues. Because they not only have a regular production process but also can provide authoritative reports. At the same time, their after-sales and other services will also be better.
FAQ
Can Industrial Silicone Be Used for Food or Medical Products?
No. Industrial-grade silicone does not meet food and medical safety standards and thus contains harmful impurities. You must firmly refuse to use them for food, maternal and child, and medical products. Once you violate this rule, you will face severe economic and regulatory penalties.
Can Food-Grade Silicone Replace Medical Grade?
No. Medical-grade silicone has much higher requirements for biocompatibility, sterilization stability, and impurity control than food-grade silicone. If you use food-grade instead of medical-grade, it does not meet the requirements of medical certification and regulations, and may also cause allergic reactions and infections among those in contact.
How Do I Verify If a Silicone Product Is Truly Food Grade or Medical Grade?
Firstly, you need to review the relevant authoritative food-grade or medical-grade tests and reject any products without the necessary certifications. Secondly, you should request the corresponding safety data sheets and batch reports from the suppliers. At the same time, you need to inspect the production environment of the silicone products to ensure there is no contamination throughout the process.
What Temperature Ranges Do These Grades Handle?
Industrial-grade silicone: usually -50℃ to 200℃. Food-grade silicone: approximately -40℃ to 230℃, suitable for high-temperature disinfection. Medical-grade silicone: Its temperature resistance range is close to that of food-grade silicone, and it can withstand multiple sterilizations.
Final Thought
Choosing the right grade of silicone will enable your business to soar. If you are looking for a responsible supplier, don’t miss Legensilico. We will select the most suitable silicone for you based on your business and requirements. Please contact us right away!
