Medical grade LSR has various benefits for medical devices and disposables, this make it ideal for medical devices’ production. There are multiple factors to determine the final decision of medical device production. Miwo as the most advanced LSR molding company in China, has produced millions of medical LSR parts for customers in worldwide.
LSR Benefits in Medical Devices
Medical grade LSR is the most suitable elastomer material for medical applications, no matter in dental surgery, healthcare products, or medical devices and disposables. Medical-grade LSR provides various benefits over other elastomer materials. All these benefits of medical grade LSR make it an ideal material for medical device manufacturing industry.
High Bio-compatibility
Medical grade LSR is bio-inertness, it never releases harmful chemicals in an organic environment. LSR has properties of inorganic and hypoallergenic, it is odorless and tasteless. This make it appropriate for medical applications. Furthermore, medical-grade LSR complies with ISO-10993, UPS Class VI and RoHS standards.
Sterilization Options
The sterilization of medical devices is essential for reusable medical devices. As medical LSR can be sterilized by various methods, such as Autoclave, ETO, E-beam, and Gamma radiation.
Thermal Stability
Medical grade liquid silicone rubber is an excellent material, it has high stability in a wide range of temperature. In the extreme temperature from -65℃ to 250℃, this LSR materials can retain its properties of resiliency, flexibility, and mechanical force transmitting ability.
Electrical Insulation
LSR materials have excellent electrical insulation property, it can maintain this property in extreme environment stress, such as extreme high or low temperature, moisture, UV, and ozone.
Pleasant Texture
Medical LSR parts with injection molding process will create products with excellent surfaces, all these surfaces are dry feeling and non-tacky to touch. In addition, we also can achieve different texture by customizing surface in mold cavity in liquid silicone molding technology.
Medical Grade LSR Applications
Medical grade LSR is applied widely in LSR injection molding, over-molding and 2-shot molding to produce medical disposables and device components. Its common applications are the following items:
Drug delivery systems
Skin contact devices
Valves
Syringe stoppers
Other customized LSR parts
In Miwo, our professional engineering team can provide all these components with high accuracy and precision.
Why Choose Medical Grade LSR
In order to ensure safety and efficiency of medical devices, these components must be bio-compatible, durable and chemical-resistant in a wide temperature range. Medical LSR provides these critical properties for many medical devices. There are significant advantages of LSR for medical usage:
Sterilization: medical-grade LSR can be sterilized by a variety of methods, like heat (auto-calving), gas (EtO) or radiation (gamma or e-beam).
Purity: different from other elastomer materials, medical grade LSR doesn’t contain any organic additives.
Flexibility: LSR is a flexible material, it has high adaptive hardness from 10 to 80 Shore A. LSR is easily molded into complex shapes. Furthermore, it also can be molded onto metal or plastics by LSR over-molding or LSR 2-shot molding technology.
Human toler-ability: medical-grade LSR is well-tolerated by humans. It won’t cause adverse reactions once contact with skin, its soft texture is comfortable for long-term usages.
Threats in Medical LSR Molding
Any medical products must avoid spreading infection or contamination. There are several sources result to hygiene threats in medical manufacturing industries. In liquid injection molding of LSR, these sources include operator, equipment, and environment.
Hygienic Molding
Hygienic molding has different level of cleanliness based on the particle count with ISO standard definition. Therefore, clean-room is often preferred by medical device manufacturers. As the most significant risk of contamination is from operators, automated Liquid Injection Molding (LIM) can reduce this significant risk. All in all, smart production and clean-room design can set the lowest interference possibility in material staging and feeding process.
Post-curing
There is still contamination risk in post-curing process, so we need to find alternative method to eliminate this risk. The new low-volatile LSR materials can reduce contamination risk by eliminating post-curing. These medical grade LSR materials are essential for further medical devices’ production.
Regardless the infrastructure and equipment, the proper clean room procedures are also essential for safe and effective manufacturing in medical industry. The key is our professional, qualified, and well-trained engineering team.
New Advanced Medical Applications
Wearable medical devices are an advanced technology for patient monitoring and drug delivery. These devices are able to monitor health and health-promoting activities. Medical grade liquid silicone rubber is the key material in these devices. It has unique properties, such as soft tactile feel, skin irritation prevention in long-term skin contact, reliable sealing performance.
Wearable Monitoring Devices
These wearable monitoring devices can monitor and analyze health data. This technology is a convenient method to monitor medical conditions without regular activities’ interference. These devices including:
- Continuous glucose monitors (CGMs)
- Electrocardiogram (ECG) monitors
- Blood pressure monitors
- Temperature monitors
- Respiratory masks and monitors
- Oxygen saturation monitors
- Heart rate monitors
- Fitness trackers
- Smartwatches
Wearable Drug Delivery Devices
The wearable Devices for drug delivery are convenient for patients, these devices eliminate excessive trip to medical facilities for chronic conditions or pain management. Wearable drug delivery devices are applied widely for diagnostics and administering of medications, treatment and therapies. Such as:
- Asthma
- Insulin
- Chemotherapy
- Antiviral medications
- Immunosuppressants
- Dialysis
- Respiration therapy
- Pain management
Medical Grade LSR Advantages
Medical LSR material is the best choice for medical wearable devices, it provides key advantages as following:
- Bio-compatibility and comfort: wearable devices are in contact with patients’ skin for hours or even all day. Medical LSR has tactile feel, this makes it comfortable to wear.
- Hypoallergenic quality: medical grade LSR materials never cause allergic reactions or irritate patients’ skin. In reason of medical grade silicone has organic backbone, and it is biochemical inertness. Medical LSR is able to apply for those with allergies or sensitive skin.
- Durability: medical grade LSR is durable, it can stand up long-term wear in different conditions, such as hot and cold, wet and dry.
- Easy cleaning: medical grade LSR is easy to clean and sanitize, it is also resistant to microbial growth.
- Regulation compliance: medical wearable devices must comply with the requirement of FDA, USP Class VI, and ISO 10993. Therefore, medical grade LSR is the most suitable material.
- Superior sealing: medical grade silicone provides low compression set, and its excellent mechanical properties protect resilient performance in harsh environment. This make it suitable for micro-components in devices.
- High-volume production: medical grade silicone is suitable for mass production of functionally sensitive components in liquid injection molding (LIM) process. We can produce millions of LSR parts with precision and continuous stability year after year.
Conclusion
Miwo has more than 10 years experience in LSR injection molding, LSR over-molding and LSR 2-shot molding. We provide unmatched expertise, knowledge and technology for extraordinary medical device solutions. Contact us now to learn more information of medical grade LSR and its applications.
