Food-grade silicone, sometimes referred to as silicone for medical use, is a common material used in consumer, medical, and industrial applications because it is safe for skin contact, flexible, long-lasting, and soft to the touch.
An elastomer is silicone. This indicates that it’s a substance that can expand and then return to its original shape, much like rubber. It is a polymer in technical terms and is well-known for being : -biocompatible,
– flexible,
-temperature and water-resistant,
– non-reactive
Using a material as strong, flexible, heat-tolerant, and biocompatible as this polymer has numerous advantages. For this reason, manufacturers of medical devices favor medical grade silicone, which is also frequently found in consumer goods like scuba gear, face shields, and cooking utensils.
What Silicone is Made of?
It’s made of sand, as you may have heard. Technically speaking, silicone is derived from silica, which is the primary component of sand. Silicon dioxide, or silica, is a compound made up of silicon and oxygen.
What is Medical Grade Silicone?
Many businesses refer to their silicone as “medical grade.” Usually, this indicates one of two things:
Long-term medical implantable material: This technical phrase refers to a substance that can remain within the body when included into an implanted device. Because of its purity, food-grade applications typically find it to be prohibitively costly.
Medical grade: Also known as medical-healthcare grade, class VI silicone that has undergone biocompatibility testing is our preferred material for a variety of products, such as water pipes, scuba mouthpieces, menstruation cups, and products that come into contact with food or skin.
Food contact is deemed safe for medical-long term implanted devices as well as medical-healthcare grade, Class VI devices. Liquid silicone rubber (LSR) is generally commonly used to designate both categories. LSR is injection molded to produce parts that are uniformly clean.
How Can You Tell if a Silicone Product is 100% Medical Grade?
Due to high material prices, many LSR products contain filler, even if the labeling says otherwise. Stretch a product with your fingers to see if it contains filler. The substance has filler if it becomes white.
Is it Expected for Silicone to go White When it Stretches? No. If so, fillers—a less expensive substitute for materials of medical grade—are present. Filler that turns white when stretched is commonly used in HCR (High Consistency Rubber). However, stiffer durometers (60, 70, and 80 durometers) have some quantity of filler required to stiffen the material. In general, stretching LSR portions still does not show this.
Limitations of Medical Grade LSR
Although silicone rubber is widely used in medicine, there are a few drawbacks, such as catheters. They have little resilience to fatigue and low tear strength, for instance. Defects inside sections may lead to brittle fracture because of inadequate vulcanization control.It led to significant breast implant failure rates and a great deal of ensuing litigation in the US and other countries. As a result, there was a crisis of confidence in the US, forcing many manufacturers to go out of business completely and forcing others to produce under FDA supervision.
Uses of Medical Grade LSR:
- Drains,
- Feeding tubes,
- Catheters,
- Silicone sheets
- gels,
- pistons,
- scar treatment,
- seals and gaskets
- Menstrual cups,
- condoms,
- non-stick containers,
- sex toys,
- respirator masks
Further Advantages of Medical Grade Silicone
Because of all of this, medical OEMs now have a plethora of opportunities to capitalize on silicone’s many advantages and wide processing parameter ranges. Because of its biocompatibility, it is even safe to use in implanted devices that are meant to be used for a long time, such as pacemakers, stents, and implantable drug delivery systems.
Silicones are also utilized in ventilation masks, atraumatic adhesives, and pressure beds (prosthetics and orthotics) to improve patient comfort because they are conformable and soft to the touch. A major advantage for the medical sector is that the material’s hydrophobicity makes it a highly effective lubricating coating for syringes and surgical instruments, and its water resistance contributes to its ability to withstand bacteria.
Silicone is also widely used in diagnostic equipment that need an internet connection and a battery to continuously track various elements of a patient’s health in real time. Because silicone can be molded at lower temperatures than typical plastics and may cling to a variety of substrates through chemical or mechanical bonding, it is essential to the success of this combination.
It’s understandable why silicone has emerged as the material of choice for medical equipment in all of its forms. Let’s examine the many kinds of silicone that are utilized by the industry in greater detail in order to investigate further benefits.
Medical Grade Liquid Silicone Rubber
The market for medical devices demands a high level of expertise and investigation, particularly in the areas of material selection and production procedures.
Material performance in the medical field can mean the difference between injury and health. Therefore, the most crucial factor to take into account when evaluating metal, plastic, ceramic, or liquid silicone rubber (LSR) for your medical device is whether or not the material will work with the functionality the equipment needs.
Engineers must take a number of issues into account when selecting materials for new medical devices and equipment, including biocompatibility, certification, cost, and regulation.
Medical device makers had trouble finding materials that fit their requirements for custom silicone molded assemblies and components before LSR came along.
Medical-grade silicone molding is well suited for consumer health care products, medical devices, and dental and surgical applications.
The Classification of Medical Grade LSR
Three classifications apply to medical-grade LSR:
Minimal exposure, sustained exposure, and permanent contact.
Minimal exposure: This category includes devices with a short service life of 24 hours or less that will come into contact with skin, mucosal membranes, or compromised and breach surfaces.
Sustained exposure: The “healthcare grade” status of this material is determined by tests like toxicity, genotoxicity, hemolysis, and intramuscular implantation with histopathology. This substance can stay in contact with an implant for up to 30 days and for more than 24 hours.
Permanent contact—also referred to as “long-term implantable”—medical silicone rubber is subjected to physicochemical and biological testing, including carcinogenicity, chronic toxicity, and developmental toxicity, that surpasses the testing methods for prolonged exposure.
How to Clean Medical Grade Silicone
When creating the original product design, it’s critical to understand which sterilization choices apply to specific device components.Here are a few cleaning options:
- Rubbing alcohol: This is among the simplest and most popular ways to sterilize silicone that is suitable for medical use. This will eliminate any dust or other particles and microorganisms that might be present.
- Autoclave: To sterilize platinum-cured LSR and eliminate microbes, an autoclave employs steam. Anything from surgical equipment to medical implants to forceps can be processed using this method.
- Under some conditions, gamma radiation is another often used technique.
- Dry Heat: Suitable for working temperatures between -45°F and 450°F, this will destroy some types of bacteria.
Conclusion
Simply said, medical grade silicones are silicones that meet medical application requirements after undergoing biocompatibility testing. In order to offer daily patient care, healthcare practitioners of all stripes—from hospitals and physician offices to labs and urgent care centers—need a variety of machinery, devices, and instruments.