Medical silicone, commonly referred to as medical-grade silicone, is an important raw material for medical devices and baby products. If you are still hesitant about whether to choose medical silicone or other materials for your products, this article will help you understand what medical silicone is so that you can make a better choice.
What Is Medical Silicone
Medical silicone is defined as a type of silicone rubber specifically designed for medical and pharmaceutical applications. It is certified according to national standards like USP and FDA, is safe and harmless, so it can be used in contact with the human body.
The mainstream medical silicone is liquid medical silicone, which can be injected into molds to form medical silicone parts of various shapes. The medical silicone also includes high-temperature vulcanized silicone rubber with higher mechanical strength and room-temperature vulcanized silicone rubber with better flexibility.
Characteristics of Medical Silicone
Element
It is high-purity silicone rubber. Compared to ordinary silicone, medical silicone has far fewer impurities. For safety reasons, it does not contain additives that could irritate or harm the human body, which are sometimes added to improve physical strength or other properties in non-medical applications. Therefore, medical devices and products made with medical silicone rarely cause allergic reactions.
Manufacturing Process
The purity of medical silicone stems from meticulous control during its production process. The raw material for medical silicone is natural, high-purity quartz sand, minimizing impurities at the source.
In a clean environment, these raw materials undergo processes such as heating, filtration, vulcanization, and secondary vulcanization, ultimately transforming into the medical silicone rubber we see. Throughout this process, the clean environment and strict quality control ensure the purity of the silicone to the greatest extent possible.
To further enhance purity, medical silicone is usually uses a platinum vulcanization process for curing, minimizing byproducts during curing. Furthermore, the platinum catalyst used in this process is relatively safe for human use, making medical silicone even more reliable in quality.
Standards and Regulations
To ensure the quality of medical supplies and protect users’ health, national and international health organizations have established relevant standards and regulations. Medical silicone generally needs to pass FDA, USP Class VI, ISO 10993, or other standard certifications to ensure its quality. These standards set clear requirements for various aspects of medical silicone.
When selecting medical silicone for your products or medical supplies, be sure to check whether the manufacturer provides these standard certifications.
Cost
Due to the high standards of materials and manufacturing processes, medical silicone is not as inexpensive as regular silicone. However, for the medical, pharmaceutical, and healthcare industries, stability and high quality are paramount. In the long run, high-quality medical silicone can avoid customer complaints and reputational damage caused by product safety issues, and its excellent stability can also help you gain a good reputation, making it a cost-effective choice.
Safety and Stability
Medical silicone is a very stable and safe material. Standard medical silicone has no components that could harm the human body, and this characteristic is extremely stable. Even after prolonged immersion in liquid, the amount of substances released is very small.
Its safety remains unchanged even after long-term use, making it trustworthy.
High-quality medical silicone is odorless and will not negatively affect the quality of the pharmaceuticals you produce.
In addition to its inherent safety, it is also chemically inert. This means that even under the complex conditions inside the human body, it will not react with surrounding chemical components, produce harmful byproducts, thereby affecting the body’s internal balance and ultimately influencing the patient’s health.
In addition to its resistance to complex environments, another characteristic of medical silicone is its ability to withstand extreme environmental factors. It has a wide temperature tolerance range and is also corrosion-resistant and UV-resistant, allowing it to be sterilized using various methods.
Whether it’s conventional autoclaving or ETO sterilization, medical silicone can withstand it without altering its properties. This ensures that your medical devices or medications are free of excessive microorganisms, which could affect their effectiveness or cause safety problems.
Biocompatibility
One of the advantages of medical silicone is its exceptional biocompatibility.
In terms of cellular compatibility, it is also an extremely high-quality material. Normally, human cells recognize abnormal substances in the body and mobilize the immune system to eliminate them. Sometimes, certain substances can cause an overreaction of the immune system, commonly known as an allergy.
Medical silicone rarely causes this abnormal or life-threatening phenomenon, and the inflammation it does cause is within an acceptable range. Once implanted in the human body, it will not adversely affect the growth and replication of surrounding cells, also meaning it will not cause cancer.
If you are looking for a material that can be implanted in or come into close contact with the human body without causing serious safety issues later on, medical silicone would be a wise choice.
Flexibility and Mechanical Strength
Medical silicone is an extremely flexible material. Unlike titanium, which is also used in the medical field, it adapts well to stretching and adjusts accordingly when the tissue or part it’s in moves or changes shape. What’s even more remarkable is that this flexibility can be maintained under high or low temperatures, making it very suitable for use in pharmaceutical environments that require high temperatures.
It is not easily cracked or worn due to external forces or temperature changes. As long as it’s within acceptable limits, once the change or applied pressure is removed, medical silicone parts can easily return to their original shape with only extremely minor alterations. This is undoubtedly crucial for medical and pharmaceutical applications that demand high precision.
Its soft and gentle nature also greatly reduces irritation to the skin and human tissues and organs, reducing discomfort during and after implantation, and bringing a better experience to your clients.
Due to limitations of the materials themselves and the use of additives, the mechanical strength of medical silicone is actually not as good as that of materials such as EPDM. In addition, some liquids or gases may seep into the other side of medical silicone products, so this should be understood before making a purchase.
Antibacterial
Medical silicone is not a suitable home for bacteria and mold. To ensure medical safety or for use in environments that can easily lead to the growth of bacteria, manufacturers may add a second barrier to medical silicone. For example, some silicone used in burn dressings contains silver ions or has an antibacterial coating on its surface.
When to Use Medical Silicone
Due to these properties of medical silicone, it can be used in many applications. Depending on its use, it is divided into three categories: Long-term implantable, long-term contact, and short-term contact types.
Long-term implantable medical silicone products
Long-term implantable medical silicone products must be tested very strictly before being used in the human body. They must be sufficiently safe and not negatively impact the body’s growth or function. Common applications of this silicone include various fillers or prostheses in the cosmetic and medical fields, and in pacemakers, providing long-term safety and reliability.
Medical silicone Products for long-term contact
If you are looking for a material with a certain degree of flexibility for catheters or drainage tubes used to transport blood, medications, and for long-term contact with the human body, medical silicone would be a good choice. The inner wall of silicone catheters does not create significant resistance to the contents, allowing for sensitive and smooth transport.
Medical silicone products for short-term contact
Medical silicone products used for short-term contact with human mucous membranes and skin are more common in life. The use of medical silicone in products such as scar patches, wound dressings, baby pacifiers, menstrual cups, and custom-made mouthguards has given a positive user experience to consumers. And the lack of odor can give your customers confidence in the product’s security.
FAQ
What Are the Differences between Regular Silicone and Medical Silicone?
Medical silicone pursues safety, while ordinary silicone, in order to reduce costs and achieve better mechanical properties in industrial manufacturing, uses lower-quality raw materials. Although it can withstand greater force, the fillers added to ordinary silicone may be harmful to the human body.
How Can I Determine If It Is Medical Silicone?
The easiest and most direct way to determine if it’s medical siliconeis to check if it meets medical material standards, including the FDA and ISO 10993. For a more visual assessment, you can also stretch the silicone. If the color changes, the quality of silicone is not very high and may not meet medical standards. However, this is only a supplementary method. Relying on compliance with standards is a more accurate way to determine its quality.
How Should I Clean Objects Made from Medical Silicone?
If you simply want to clean silicone products for external use, you can just wipe the surface with alcohol or soak them in alcohol for a period of time.
Medical silicone products used as medical devices can be sterilized using autoclaving, a sterilization method widely used in laboratories and medical fields. High-temperature and high-pressure steam can effectively eliminate microorganisms.
Can I Sterilize Medical Silicone by Putting It in Boiling Water?
Of course. Medical silicone has excellent stability. The temperature of boiling water is not enough to damage it or cause it to release harmful chemicals, nor will it easily age due to high temperatures within its operating range.
Where Can I Buy Medical Silicone in Bulk?
You can purchase medical silicone from local medical supply stores. Alternatively, online channels such as Alibaba and Grainger are also convenient ways to obtain it. If you are trying to find a reliable and more affordable source of medical silicone, consider Legensilico, a professional silicone manufacturer from China.
Final Thoughts
The quality of medical silicone has a significant influence on the safety and lifespan of the product. Legensilico provides you with a one-stop service for silicone products. As a silicone product manufacturer with over 20 years of experience, we offer customized services for high-quality, FDA-compliant medical silicone products like silicone gloves and provide you with adequate security guarantees. Let’s take action now!
