Know about silicone and its processing techniques in medical devices design

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Know about silicone and its processing techniques in medical devices design makenica.com/know-about-silicone-and-its-processing-techniques-in-medical-devices-design February 5, 2021

The popularity of silicone molding Bangalore has been growing for medical devices. This is due to its compatibility and strong chemical structure with body fluids. Advances in medical polymers are also part of this push toward single-use medical equipment, implants, and packaging technology for the next generation. It is vital to choose the best technologies to configure the silicone components with silicone moulding Bangalore for the right application to get the suitable material, design, and production process for the correct end product use. The advantages and drawbacks of many silicone molding Bangalore processes plus postfabrication facilities such as coating, sheeting, tubing, and packaging will be evaluated in this blog post.

Silicone molding Bangalore - Processing techniques 1. Injection Molding Injection molding has its advantages: it is incredibly useful in the development and can produce very complicated and delicate parts. Usually, injection molding requires a single mold with different cavitations to create many parts. 1/6


The component and application could be ideal for liquid injection moulding (LIM) or liquid silicone rubber (LSR). LSR may also potentially be used with a 2-shot (or more) fully automatic injection molding set-up in conjunction with engineered plastic. Developing a tool-grade steel mold, hot or cold runner blocks, and process automation equipment can be costly upfront, following the finished product's complexity. This expense must be taken into account with every production program. However, because injection molding and much more so liquid injection molding, over very high volumes will yield high integrity components, the tooling can be a comparatively low price considered over the life of a program on a piece-by-piece basis. The mold's quality depends on cavitation choices, the geometry of the parting-line, gating, venting, surface finish, and automation help. To minimize the inherent lot-to-lot variability of raw silicone, it is essential to ensure the mold is robust enough. It would also need to be seamlessly combined with machines that pump, blend, inject, compress, heat, and eject. Molds must be meticulously crafted and produced accurately, adding to the process a degree of complexity. Usually, making a mold for a seal to be used in a medical system involves early, close cooperation with the device maker and the specialists in injection molding engineering at the seal manufacturer. Through refining seal geometry, tooling, and process engineering, the idea is to ensure the right material selection and compliance with regulations, thus mitigating uncertainty, maximizing yield, and reducing costs. Advantages Molding with Liquid Injection Produces intricate designs; suitable for extremely detailed components such as undercuts or thin-wall parts Capacity to mold micro-and nano-sized components Adopts hard-soft variations via a 2-shot LSR process Best performance of any molding technique with fast cycle times and full automation possibility, suitable for huge volumes Injection Molding Enhanced strength; fillers can be used when molding to decrease the density of the silicone, further reinforcing the molded component Different forms of silicone can be used and modified to the product conditions and molding phase needs. It is possible to insert metal or plastic elements into the component. An effective procedure for medium to high volume technological parts in the semiautomation field

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Disadvantages Liquid Injection Molding The highest initial cost of tooling and must be treated as an expense over a tool's life; which, moreover, is the most extended alternative molding tool of any kind, i.e., 1 million shots Injection Molding Design limitations, including the fact that all materials must be sturdy and have drafting if they are perpendicular to the opening of the tool To prevent shrinkage concerns, there could be limitations on component thickness Needs service of component de-flashing with added costs 2. Compression Molding The compression molding method is suitable for parts outside the extrusion or injection molding size capability and in low concentrations for moderately complicated parts. In medical applications such as diaphragms for breathing systems, lip seals for cylinder applications, and insulation bumpers to inhibit vibrations, compression molding is used. To create thermoset plastic components, compression molding is often used. The raw materials are either granules, putty-like masses, or preforms for compression molding. In an open, heated mold cavity to which pressure is applied, the raw material is inserted in, pressing the material to fill the cavity. Advantages Cost-efficient for smaller volumes; low cost of the tool Parts from specified materials can be made to customer specifications Design of Flexible Mold It is possible to generate tools with several cavities Quick turnover of instruments and components Good finish to the surface Disadvantages Slower production rates of part Flash control can be hard to control; post-operation requires Precision is fine for rubber sections but restricted to an average amount. Only smooth or mildly curved pieces with no undercuts are primarily used to manufacture 3. Extrusion Thanks to developments in thermoplastic polymers, such as polyether ether ketone (PEEK), polyurethanes, and polyolefins, plastic tubes are being replaced by metal tubes in many medical instruments. 3/6


For example, PEEK is an excellent alternative to stainless steel and other metals often used in medical-grade tubing because it is extremely strong and has a low friction coefficient. Similarly, both PEEK and polyphenyl sulfone (PPSU) are used to produce parts for long-term implantable components because of their biocompatibility. Advantages Accommodates high volumes of production Provides successful melting For plastics, it enables post-extrusion manipulation. Allows tremendous versatility in the manufacture of goods with a clear cross-section Disadvantages Difficult to estimate the exact magnitude of expansion There can be differences in scale There may be product limitations 4. Multiple-profile extrusion (MPE) Originally designed to improve closed-wound drainage materials, MPE prevents secondary bonding operations by bonding with a range of tube profiles. The method produces a single, continuous tube, removing the need for leak checks. It also allows for "on-the-fly" manipulations, causing the silicone tube's cross-section profile to alter during extrusion, thereby lowering costs. Just as significant, the lack of seam significantly increases the component's efficiency, removing places where bacteria can collect. MPE enables the extrusion of balloons of any length utilizing a rotating mandrel that retains a fixed outer diameter while thinning the wall to vary the inner diameter. This removes the need for secondary bonding requirements, decreases costs, and improves output speed. Double extruder configurations allow for a wide variety of rigidity and durability in tubes. The amount of flexibility can be managed by thinning out the extrusion wall or moving to a softer or stiffer material anywhere in the extruded profile. In the MPE method, two or more lumens can easily be isolated from the center lumen or combined into a single lumen—all in a single continuous extruded tube. The multi-lumen method involves shifting dies and mandrels in unison, eliminating the crosscontamination of fluids in different lumens. Advantages Facilitates the extrusion of balloons of any length; Eliminate secondary bonding activities Allows the seams to be removed

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Various tubes (single lumen, multi-lumen, transient trans, etc.) can be made, rod, ribbon, and other non-standard profiles. Suitable for extrusion in all elastomers and foams Disadvantages Material options limited to the HCR (high consistency rubber) Issues can emerge from having to transfer dies and mandrels in sync. Cross-contamination of fluids in different lumens can occur. Finishes and post-manufacturing in Silicone moulding Bangalore 1. Silicone dip molding and coating Steel, rubber, fabric, and glass medical components can all be covered with thin silicone film, which is then vulcanized to create a clean, robust, biocompatible finish. For example, dip molding of silicone molding Bangalore can produce silicone coatings on instruments such as needles, cannulae, and syringes to improve patient comfort. Dip molding may also be a cost-effective solution to silicone molding Bangalore methods in situations requiring expensive metal molds. It is suitable for rapid prototyping of complicated, thin-walled shapes that can later be scaled up for large-volume industrial production. The dip molding process involves creating a mandrel in the form of the final component. Mandrels are typically machined from aluminum, but they may be made from engineered plastics and ceramics. The mandrel is immersed in a silicone dispersion vessel and then removed. Mandrel, now covered with a thin layer of liquid silicone, is put in an oven where silicone is vulcanized. After vulcanization, the silicone rubber is stripped of the mandrel, and the finished product is made. The wall thickness can be modified by changing the number of dips and adjusting the proportion of the solid concentration of the silicone dispersion. Several variables contribute to each component's consistency and reproducibility, including the assessment of the surface finish of the mandrel, the angle and speed of immersion and withdrawal, the viscosity and temperature of dispersion, the atmospheric manufacturing conditions, and the vulcanization parameters. 2. Calendaring and sheeting In high-consistency rubber (HCR) calendaring, silicone is fed through several rollers to create a uniform thickness film. The film is then moved to the carrier sheet and can be cured or left uncured.

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Calendar sheeting can be pigmented, manufactured with various surface finishes, and used to manufacture vulcanized, non-vulcanized, reinforced, and non-reinforced goods. The method works exceptionally well for the production of mandrel-wrapped hoses and ducts, as well as die-cut seals. Custom sheeting is used in a wide range of medical instruments. Punching disks from vulcanized elastomeric sheets are the main components of various valve assemblies. Mesh-reinforced sheeting is integrated as stitching rings on artificial heart valves. Laminated sheeting comprising both vulcanized and non-vulcanized layers is used to manufacture seal tissue expanders and mammary instruments. 3. Assembly, packing, and sterilization Post-manufacturing of silicone moulding Bangalore – including complete assembly, packing, and sterilization of equipment – is a final factor for silicone production. Not all vendors have a wide range of capabilities, and often parts of silicone are part of a more comprehensive, more sophisticated device. Conclusion The potential of silicone molding Bangalore and silicones to produce exceptional efficiency, esthetic or medicinal properties make them well suited for many medical devices. However, manufacturers must show a good knowledge of the specifics involved in producing both silicone rubber components and complex medical equipment with silicone moulding Bangalore. With time-to-market, such a vital factor in the production and selling of medical equipment, the ability to manufacture fast designs, rapidly achieve a final design, and reliably produce and supply high-quality products with Silicone Moulding Bangalore are essential to success.

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