For medical device manufacturers, medical and cosmetic locations, choosing the right silicone cleaning methods is important to ensure medical safety and extend the life of your products. This article will take you through the ways in which medical-grade silicone can be cleaned to make your silicone products last longer.
What Is Medical-Grade Silicone?
Medical-grade silicone is silicone rubber that has passed safety certifications such as ISO 10993, USP Class VI, and can be used in the medical field, sometimes called medical silicone.
In general, medical-grade silicone is silicone rubber produced using a safer, platinum vulcanization process that doesn’t produce toxic byproducts, with medical-grade liquid silicone rubber (LSR) being the most common.
It is widely used in medical products such as catheters, O-rings, implants, and other safety-conscious high-end consumer products such as baby pacifiers and teething pads for its wide temperature adaptability range, excellent biocompatibility and stability.
Medical-grade Silicone Daily Cleaning Methods
Medical-grade silicone does not inherently adhere to stains or allow bacteria to grow on it, so you can easily perform routine cleaning tasks on baby products, daily care products, and general medical equipment.
Cleaning Tool Selection
Because medical-grade silicone is a soft material, the tools used to clean it should be gentle and soft. Cloths and sponges work well to clean the surface of medical-grade silicone without harming it. If your medical-grade silicone products have hard-to-clean crevices or complex structures, you can also use a soft-bristle brush to carefully clean them.
Cleaning Agent Selection
Although medical-grade silicone is chemically inert and will not react with most substances, it can be corroded by strong acidic and alkaline cleaning agents, which can lead to a shorter service life and reduced safety.
Acetone and other solvents that cause medical-grade silicone to swell, and cleaning agents that may leave residues, are also unsuitable. Some cleaning agents may contain abrasive particles, which can damage medical-grade silicone products. You should avoid these when choosing a product. For specific cleaning agents or chemicals that can be used to sterilize a particular product, please check the instructions carefully or consult the manufacturer.
Soaps and detergents are suitable cleaners because they are gentle enough. What’s more, it is best to purchase unscented cleaners because the scent may remain on the silicone product, causing odors and safety hazards.
You can also choose to buy cleaning agents that are specialized for medical equipment, especially if you want to do cleaning work in bulk for medical equipment in the hospital.
Step-by-step Cleaning Process
- Step 1: Mix warm water and cleaner well before preparing for cleaning. If your medical-grade silicone products have more complex removable structures, separate them for easier cleaning.
- Step 2: Soak your medical-grade products in the mixed solution and use a cloth to carefully clean the surface of any pollutants, such as dust, dirt, and medications present. Tight crevices, the inside of pipes, or textured surfaces can be cleaned with the aid of a soft-bristle brush.
- Step 3: Rinse the surface of the medical-grade silicone product with water to ensure that no detergents or other chemicals remain.
- Step 4: Wipe the surfaces with a dry cloth to remove any residual moisture and leave them to dry in a ventilated area out of direct sunlight. Until the medical-grade silicone product is completely dry, store it or install it back.
If you would like to learn more about how to store silicone products, you can read Silicone Product Maintenance Guide: How to Clean, Store, and What to Avoid.
Thorough Cleaning Method for Medical-grade Silicone
Boiled
In addition to daily cleaning, baby products and healthcare products made with medical-grade silicone need to be thoroughly cleaned and sanitized on a regular basis, especially if they have residual odors or certain stains that are difficult to remove completely.
Since most medical-grade silicones are heat-resistant, they can be sterilized by placing them in boiling water. Before sterilizing by boiling, make sure that your silicone products are made entirely of medical-grade silicone that is heat-resistant and is not used for bonding.
You can place them in boiling water for 5-10 minutes. If this is too long, it can cause damage to the medical-grade silicone products. When boiling, you should also make sure that the product is heated evenly and is not touching the bottom of the pot.
Use Baking Soda
Baking soda is a godsend against hard-to-remove stains on medical-grade silicone products. You can make a paste with water and then apply it to the areas that need to be cleaned. After a short time, you can scrub and rinse them off with a cloth.
This way of cleaning doesn’t harm the silicone and helps to keep it working longer than other more brutal cleaning methods.
Sterilization Methods for Medical-grade Silicone
In order to ensure the safety of medical processes and to prevent patients from being infected by pathogens and bacteria in medical equipment and tools and pharmaceuticals that can lead to serious infection problems, they have stricter hygiene requirements. As a result, larger medical facilities, medical aesthetics, and pharmaceutical equipment often require more specialized means of sterilization.
Alcohol Disinfection
Medical Alcohol is a commonly used disinfectant in the medical field and is effective in killing most bacteria. Medical alcohol can certainly be used to sterilize medical-grade silicone. You can apply or spray a thin layer of alcohol and wait for it to evaporate naturally.
This sterilization method is easy and can be used on a wide variety of medical-grade silicone products. If your customers are concerned about the safety of their healthcare products, you can also recommend that they sterilize them this way.
However, please be careful not to use alcohol too often, as it can have an impact on the lifespan of medical-grade silicone products.
Autoclaving
Autoclaving is the most commonly used sterilization method in the medical and chemical fields, and is the method that can be used to sterilize medical-grade silicone for long periods of time with less harm or risk to it.
In an autoclave, steam that has been heated and pressurized to very high temperatures effectively kills a variety of microorganisms. Because these steam temperatures can reach 121°C, much higher than the normal temperature at which water boils in life, it is much more effective than boiling.
You also don’t need to worry about repeated autoclaving causing serious damage to your medical-grade silicone product or causing it to release toxic chemicals. As long as it is a silicone rubber that has been certified to ISO 10993, autoclaving temperatures are generally within its tolerance range.
This tolerance is limited to sterilization temperatures of 121°C or less, and if you use higher temperatures, such as 134°C steam from a pre-vacuum sterilizer, the steam can really shorten the life of the medical-grade silicone product.
Autoclaving can be commonly used for silicone implants, surgical instruments, and many other medical-grade silicone products. It is important to note that this method of sterilization can severely degrade or even scrap the adhesion of composite products such as silicone scar patches.
Silicone products that are intended for disposable or short-term use, or that are made into products with other materials, are not necessarily able to withstand the high temperatures of autoclaving. Before using this method of sterilization, make sure that the silicone product is made of pure silicone rubber and that it can withstand the high temperatures.
Dry Heat Sterilization
Some composite medical-grade silicone products can’t withstand autoclaving, so dry heat sterilization is used as an alternative method for these products. It also uses high temperatures to sterilize silicone products, but utilizes dry, usually 160°C hot air.
Because the heat of the air doesn’t easily transfer to the interior of the silicone, this sterilization method takes longer. And because of the higher temperature of the air it uses, this method has a greater impact on medical-grade silicone products than autoclaving and may make it brittle or yellow.
Gamma Radiation Sterilization
Gamma radiation sterilization is a sterilization method applied to medical-grade silicone products that don’t tolerate high temperatures. It can be performed at room temperature and can therefore be used to sterilize products such as scar patches and silicone dressings.
Silicone materials have a very stable silicone-oxygen backbone structure, making it more difficult for gamma rays to damage. Gamma rays can kill bacteria by disrupting their genes as well as contributing to the production of extremely active free radicals around the microorganisms.
Because of its high penetrating power, gamma sterilization can be easily and quickly achieved as a total sterilization.
If you use gamma sterilization for a long period of time, the flexibility and some of the physical properties of the medical-grade silicone may be reduced, but these changes are minor.
Ethylene Oxide(ETO) Sterilization
Ethylene oxide (ETO) sterilization is the ultimate solution for silicone products that contain components that are not resistant to heat and radiation. It is often used to sterilize medical plastics that may melt at high temperatures, and can be used to sterilize a wide range of medical materials, including silicones.
However, it has one very obvious drawback – ETO is inherently toxic, and a small amount of ETO can remain inside the silicone after sterilization is complete. It usually takes a long time for these residues to slowly release after sterilization with ETO.
ETO sterilization also has very high requirements for the sterilization environment. In addition to being toxic, it is a flammable and explosive gas. If you want to adopt this sterilization method, it may be costly to bring the sterilization environment up to safe standards.
Common Mistakes during the Cleaning of Medical-Grade Silicone
Using Abrasive or Hard Cleaning Tools
Cleaning with tools such as steel wool, dishcloths, and stiff brushes can cause a lot of damage to medical-grade silicone products. Since silicone is a soft, flexible material, its surfaces can be abraded by the friction of these hard cleaning tools or left with many tiny scratches.
If the surface of a medical-grade silicone product is smooth, this can make it rough. These uneven “wounds” allow stains to remain on them, as well as bacteria, making subsequent cleaning of the silicone product much more difficult and shortening its service life.
They can also cause the texture of medical-grade silicone products to fade or disappear, depriving them of the anti-slip and other capabilities for which they were designed in the first place.
Not Completely Dry
If medical-grade silicone products are not dry thoroughly after cleaning, especially if they are placed in sealed containers or bags directly after cleaning, they can easily grow mold in a humid environment.
Whichever cleaning method you choose, make sure medical-grade silicone products are thoroughly dried before storing them.
Using Hot Water to Wash Blood Stains
Hot water will let the blood on your medical-grade silicone products clot on the surface. They then form a stronger connection to the surface of the product, making it more difficult to clean.
When cleaning blood from medical-grade silicone products, it is best to pre-rinse and soak them in cold water before washing them with warm water and detergent.
Use Alcohol to Soak for a Long Time
While alcohol can be used to sterilize medical-grade silicone products, this doesn’t mean that it is correct to soak them in alcohol for extended periods of time for more thorough sterilization.
Prolonged immersion can cause the alcohol to enter the structure of the silicone, causing it to soften and swell. After drying, this effect doesn’t completely disappear, and you may find that medical-grade silicone products become sticky or whitish.
Alcohol is also a good solvent, and coloring or other additives present in the medical-grade silicone product may dissolve in it, leading to further degradation of the product’s properties.
FAQ
Can Medical-grade Silicone Products Be Cleaned with Bleach?
It is not recommended that your customers sterilize medical-grade silicone products at home with bleach, because bleach may harm them.
If the instructions indicate that they can be sanitized with a specific type of bleach, then bleach can be used to clean medical-grade silicone parts when the instructions are strictly adhered to.
Are There Any Cleaning Agents Specifically Designed for Cleaning Medical-grade Silicone?
Yes. Generally speaking, you can find cleaners that are specifically designed to clean medical devices or equipment, and they are also suitable for use with silicone materials that are commonly used in the medical field. You can also look for medical cleaners that are labeled “silicone safe”.
How often Should Medical-grade Silicone Be Cleaned?
Medical-grade silicone products or baby pacifiers that are contaminated with medications, blood, or saliva should be cleaned promptly after use. For external medical devices with a low frequency of contact, weekly cleaning is appropriate. You can refer to the instructions for your specific product for more detailed recommendations on cleaning frequency.
Final Thoughts
Medical-grade silicone is a safe, durable material that can be used with a variety of cleaning methods. If you’re looking for high-quality, medical-grade silicone products that are ISO 10993 compliant, Legensilico, a manufacturer of silicone products, is a trustworthy partner.
