The stress on long-run monetary value and price stability has a direct effect on manufacturers ’ sales revenues and profits .
The aesculapian device market requires a fortune of skill and research, specially in the areas of material choice and manufacture processes .
In the aesculapian diligence, material performance can be the deviation between health and injury. consequently, whether you evaluate metallic, fictile, ceramic or Liquid Silicone Rubber ( LSR ) for your checkup device, the most significant aspect to consider concerns the compatibility of the material with the functionality the equipment requires.
When it comes to choosing materials for newly checkup equipment and devices, engineers need to consider a diverseness of factors, such as biocompatibility, qualification, regulation and monetary value .
For silicone medical devices, many applications have components that have the lastingness to withstand a variety of sturdy conditions, such as heating system, high gear pressure, chemical exposure and biocompatibility .
Until LSR came along, checkup device manufacturers had a unmanageable meter finding materials that meet their criteria for customs silicone molded components and assemblies .
Medical-grade silicone model lends itself to dental and surgical alveolar consonant applications, consumer health wish products and other aesculapian products and devices .
READ OUR LSR IN THE MEDICAL INDUSTRY GUIDE
WHAT IS LIQUID SILICONE RUBBER?
Over the end hundred years, material innovations in basic and forte elastomers have led to a range of materials that are suitable for a broad range of applications and operating environments .
The materials vary in terms of key characteristics, such as elasticity, forte, hardness, compatibility, temperature range, environmental resistance and other properties .
One of these materials, LSR, which has been around since the 1970s, continues to make the passage to becoming the premier material for the manufacture of checkup products and devices. LSR consists of a highly elastic thermosetting credit card that comes in a broad range of composition and hardness .
The variety of LSR materials allows product designers and engineers to select the material with the characteristics most appropriate for the application .
At room temperature, thermoplastic begins as solid material, which softens when you heat or reheat the material above its dissolve point .
In comparison, thermosetting materials start out in liquid form, and the heat cures the resin into a solid country. Once it cures, the part remains solid — a feature of speech that helps make LSR the mind material option for numerous aesculapian applications .
The samara attributes of LSR include :
- Tensile strength
- Compression set
- Fluid resistance
The benefits of medical-grade LSR over elastomeric materials include :
- Bio-inert material in compliance with ISO 10993, USP Class VI and RoHS standards
- Ability to be sterilized with a variety of methods such as Autoclave, ETO, E-beam and Gamma radiation processes
- Low viscosity that allows flow to all parts of the mold
- Excellent stability over a broad range of temperatures 150°F to 450°F
- Low compression set
- Self-adhesive LSR that chemically adheres to plastics without the need for priming
- Ability to maintain its resiliency, flexibility and capability to transfer mechanical force at extreme temperatures
LSR has superior electrical isolate qualities even under the most hard environmental conditions. The manufacturer can acquire cast cavities specifically tailored to achieve different surface textures for parts and products .
THE IMPORTANCE OF MEDICAL-GRADE LIQUID SILICONE RUBBER
Dr. Frank Lahey receives credit for the first-known use of elastomeric silicone to repair a affected role ’ second bile duct in 1946. Lahey was attracted to the material because of its stability and elasticity, which allow the corporeal to be cast into virtually any form .
today, a kind of silicone materials meet the standards for medical device manufacturers, including checkup non-implantable, medical restricted implantable and aesculapian unexclusive implantable .
One of the primary reasons silicone has developed into a key material for medical applications has to do with the biocompatibility of the material and the ability to use it in a broad align of life-saving aesculapian devices such as pacemakers and hydrocephalic shunts .
Innovations in material science have made non-implantable materials more normally available in a variety of durometers. This makes it potential to fabricate medical devices of varying hardness levels .
Non-implantable class LSR for mold-making can come into contact with the clamber, but not the inside of the soundbox. checkup silicone condom must undergo particular safety testing evaluation .
ISO 10993 provides a multipart standard used cosmopolitan to evaluate the biosafety of this material. LSR meets the criteria as outlined by ISO 10933 for use in medical applications .
Medical-grade LSR falls under three categories : restrict exposure, prolong exposure and permanent contact .
- Limited exposure — For devices that will come into contact with skin, mucosal membrane or compromised and breach surfaces, this category has a brief service life of 24 hours or less.
- Prolonged exposure — This material, referred to as “healthcare grade,” is based on tests such as haemolysis, genotoxicity, toxicity and intramuscular implantation with histopathology. This material has a surface or implant contact of more than 24 hours and up to 30 days.
- Permanent contact — Also known as “long-term implantable,” this medical silicone rubber must undergo physiochemical and biological testing that exceeds the testing protocols for prolonged exposure, including carcinogenicity, chronic toxicity and developmental toxicity.
If you have a new or existing application that requires any type of housing, valve, dampener, gasket, seal, coupling, or membrane button — uses that could benefit from inertness, low compression set or temperature resistance — could realize substantial benefits from medical LSR medical-grade liquid silicone .
THE ADVANTAGES OF MEDICAL-GRADE LSR OVER ALTERNATIVE MATERIALS
Medical-grade LSR approved for aesculapian applications where it will come into contact with skin has frightful stability and is water repellent, which prohibits cured fabric from being affected by contact with skin. Unlike materials such as latex, LSR is non-allergenic, so the fabric does not affect the skin .
The hygienic quality of LSR helps it to resist the growth of bacteria and fungi. LSR has the implicit in qualities of flexibility and softness, which ensure the affected role ’ second quilt. The water-repellant characteristics prevent the material from sticking to wounds .
LSR can not only tolerate heat, but it besides remains extremely elastic at identical low temperatures. The flexibility of the fabric depends upon the nature of the colonial, but it is typically very high. For example, some LSR materials have an elongation break of 1000 percentage .
LSR besides has a low compaction set or low permanent wave contortion upon the application or removal of pull. LSR besides withstands ultraviolet radiation well. The stability of the cure part prolongs the product ’ mho shelf liveliness .
While many designers compare LSR to thermoplastic elastomers ( TPS ) like Santoprene™, LSR has developed a reputation the as “ TPE on steroids. ” LSR costs more than other resins. The material besides has a longer cycle clock time for the mold process compared to early thermoplastics .
however, LSR allows you to combine multiple components and reduce the cost of production runs. however, the overall capabilities of LSR make it a fresh choice for many medical device applications .
The benefits of selecting medical-grade LSR over early options include :
- FDA biocompatibility
- Resistance to chemical and bacteria
- Excellent transparency, which allows light transmittance and illumination
- Gas permeability
- High elongation
- Superior dielectric strength
- Superior tensile strength, elongation, tear strength and compression at temperature extremes
- Ability to function in extreme temperatures
- Low compression set at wide temperature ranges
Compared to high-consistency arctic ( HCR ) and other elastomers, LSR makes a better material choice for manufacturing high-precision medical components and devices with detail geometries that require high accuracy .
MEDICAL DEVICES MANUFACTURED USING LSR INJECTION MOLDING
The substantial used to fabricate medical devices consists of LSR. Some components may require multiple shape processes, which requires a thorough evaluation of different fabrication variables, such as product lifecycle, production book, function geometry and material type.
The liquid injection molding summons requires the shuffle of two parts of LSR in a static mixer before transfer to the cheat. The cheat forces the material into the shape in a certain shoot size. This summons much automates LSR molding of choice parts at a high volume .
merchandise designers choose LSR for the design and industry of checkup silicone parts and devices for a across-the-board range of applications. Specialty medical fields that use LSR medical injection molding admit :
- General surgery
- Bariatric surgery
- Plastic surgery
- Wearable health monitoring devices
- Ear, nose and throat
When choosing a material for your project, the monetary value of LSR may become a stick point. unfortunately, many medical products and device manufacturers make a strategic decision to compromise on intersection design and performance so they can save money on up-front tool costs .
however, the excerpt of medical-grade LSR pays off in the kind of improved quality and better performance .
Over the long run, aesculapian products and devices molded from LSR can withstand the most challenge conditions .
OVER-MOLDING MEDICAL DEVICES WITH LSR
The medical market and healthcare industry requires materials and processes that will allow manufacturers to create a product with tighter tolerances, sterilization capabilities and soft-touch surfaces and colors .
Over-molding describes a fabricate method that adds another layer of substantial over an existing partially. The action goes by other names, such as multi-shot, double-shot, hard/soft overmolding, twin-shot mold and 2K molding. The proficiency has taken root as a viable manufacture action in the medical diligence as product-makers realize the enormous benefits .
Over-molding is an injection molding action that has drastically changed the aesthetics, design and functionality of medical products over the last few years .
Surgeons and other clinicians have become more enchant with devices and surgical instruments that have soft-touch handles, which improve the bag. Over-molding allows for the fabrication of handles into an ergonomic condition that fits into the hands of the end drug user or interacts with attachments .
The decompose starts by overmolding a shaft of metal with LSR to form the craved shape. The decompose uses thermoplastic to create the soft-touch handle .
The process allows product designers to create parts with seamless surfaces and no gaps, which eliminates traps for contaminants. The transparency of LSR corporeal allows the surgeon to see through the instrumental role and work with more preciseness .
The over-mold method acting has increasingly grown as a viable action in the medical marketplace because more device-makers realize its potential advantages .
This procedure works good for products or devices that require handles, biocompatibility, heat resistance or chemical resistance. Some gentle thermoplastics such as TPE can replicate some of the characteristics, but LSR has attributes that far outweigh the properties of other materials, including lastingness, biocompatibility, cold and resistor to heat, chemicals and UV light. LSR besides has unparalleled flexibility and moldability .
COST SAVINGS MANUFACTURING WITH LSR
product designers come under increasing cost blackmail, which means they must be more creative .
consequently, the mantra is to mold arsenic much functionality into the region as is feasible, while simultaneously minimizing corporeal cost, secondary processes and assembly. The separate must besides have geomorphologic ridicule to improve functionality .
The part serves as the skin and a structural member of the frame. For surgical instrumentation, overmolding over plastic and alloy has become preferable to machining an entire instrument from metallic or debase .
merchandise manufacturers find they can trim costs by molding over a while of alloy and having the alloy only where needed, i.e. the cutting area, and casting the remainder of the instrument in credit card .
The ability to mold in intricate geometries saves machining an integral device. It is particularly conducive to high-volume production and costs much less than traditional machine .
BRANDING IDENTIFICATION FOR LSR MEDICAL DEVICES
many companies employ the overmolding march to brand their company ’ second name, logo, color or early characteristics into the product .
The process is besides conducive for fabricating parts where the specifications call for a tight allowance, wholly closed contribution or very thick parts. Molding over credit card is a beneficial solution, producing hearty surfaces, both top and bottom, and very compact parts .
LSR enables partially designers to eliminate the prime tone .
You can add LSR entirely where needed on the character to serve a functional purpose, without needing to cover extra airfoil area in order to keep the LSR in place .
conversely, the areas of the separate that do not require overmolded LSR no longer need to increase the thickness to endure the estrus of curing the material .
You will manufacture your parts more economically because you use only equally many materials as needed, which results in smaller parts .
MEDICAL-GRADE LSR CAN GIVE YOUR PRODUCT A COMPETITIVE EDGE
The ever-evolving and highly advanced nature of the checkup industry makes it necessary to have a material like medical-grade silicone rubberize to fabricate products ranging from tubing to life-saving healthcare devices .
The gamey degree of repeatability by applying high-quality shape methods and automation vitamin a well as the ability to automate the process and the production of flash-less products lends itself to high-volume production .
The ability to access LSR blends enables aesculapian merchandise manufacturers to strike the appropriate counterweight between the characteristics and material .
Adding a work like the LSR 2-shot injection molding process can catapult you above your competitors .
At SIMTEC, our sole focus is on LSR, so we have the feel and expertness you require to manufacture large quantity ( +500,000 item ) intersection orders .
We have fine-tune our process so we can systematically produce high-quality products .
SIMTEC ’ randomness Miramar, Florida fabrication facility is ISO 9001:2015, ISO 13485:2016/NS-EN ISO 123485:2016, and IATF 16949:2016 certified. This means we adhere to a fix of repeatable processes so that each character we produce is of a uniform size, shape, and consistency.
We have one of the lowest defect rates in the industry, and we can customize our QC protocols to reflect your particular regulative and internal requirements .
class VIII ( 100,000 ) and Class VII ( 10,000 ) blank room facilities are besides available to limit exposure to dust and other airborne particles. If you need a custom-made product made using medical-grade silicone model, SIMTEC is here to help, from assisting with mold design to prototyping .
To learn more about medical-grade Liquid Silicone Rubber or receive a release quote, contact a SIMTEC representative today .