Custom Spring Energized PTFE Seals for Medical Devices
The medical device industry faces continually evolving challenges when it comes to finding the right sealing solutions for new and improved designs. Issues such as sterilization, wide ranges of expected pressure, potentially aggressive environments, and FDA and USP approval make the design and specification process quite challenging. In this article, we are going to look at custom spring energized PTFE seals as a potential solution for sealing challenges in the medical industry.
Why PTFE Seals?
PTFE is a popular choice for spring energized seals for medical applications for several reasons. One is the fact that certain grades of PTFE have been approved by the FDA as USP Class VImaterials. It is resistant to a variety of aggressive chemicals, has extremely low friction, and retains its key characteristics – including strength – over a wide range of temperatures and pressures. It can be sterilized using methods such as steam and EtO (ethylene oxide), and is both hydrophobic and oleophobic.
Why Spring Energized Seals?
As you probably already know, spring energized seals are able to achieve a seal at low pressures because the spring applies outward pressure to the lip of the seal against the shaft or bore. As pressures increase, the pressure itself takes over from the energizing spring and achieves a tight seal. The result is an effective sealing solution.
Where Are Energized PTFE Seals Used in the Medical Device Industry?
PTFE seals are a common sight in the medical device industry, found in everything from dialysis equipment and infusion pumps to oxygen therapy, implanted electronic devices, trochars, and IV systems. Spring-energized PTFE seals are used in medical instruments, drug delivery systems, and orthopedic applications, just to name a few.
Custom Seals
Custom seal designs are available to meet the complex needs of the medical device industry. This includes custom engineering of the polymer (including fillers), unusual sizes or geometries, special spring materials, and more. In addition, PTFE lends itself to manufacturing processes such as machining that offer a high degree of accuracy and precision.
Conclusion
PTFE seals are popular in the medical device industry for a variety of reasons, including their low friction, chemical resistance, and excellent performance in a variety of pressure, temperature, and speed situations. Spring-energized PTFE seals provide a reliable sealing solution that is effective even in low-pressure environments. Even if an off-the-shelf energized PTFE seal won’t meet your needs, you can look into a custom-designed energized Teflon seal tailored to your requirements and specifications.
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Comparison Between PTFE and PFA Processing
For a number of years fluoropolymers have played a significant role in the chemical and similar industries to protect plants and equipment against chemical attack by a broad range of aggressive media. This is because they offer substantially better chemical resistance and thermal stability than other plastics or elastomeric materials.
Following the development of PTFE, the introduction of melt-processable fluorinated ethylene-propylene (FEP) in 1960 opened up entirely new application areas. PFA, a perfluoro-alkoxy polymer which has been in successful use for 20 years as a lining material, is now a thermoplastic successor to PTFE, with equivalent thermal and chemical resistance and superior properties with respect to processability, translucency, permeation resistance and mechanical strength.
In the chemical industry, both fluoropolymers - PTFE and PFA - are used mainly in the form of linings (fig. 1, 2). For simple shapes, such as pipes, bends, T-pieces or reduction joints, PTFE is generally used; it is applied by means of paste extrusion, ram extrusion or tape wind-ing (fig. 3). In these processes a pre-form is made of the PTFE; this is then sintered and inserted into the metal workpiece. Using PTFE for lining of metal parts of complicated shape, such as valves and pumps, is more difficult. Isostatic molding is then the preferred method. In this PTFE powder is filled into the space created between the metal work-piece and a rubber bag which is specially made to fit into the shape of the area to be lined. The powder is pre-compressed, then cold-pressed into the desired shape. Finally, the rubber bag is removed and the lined part is sintered in an oven at over 360?C (680?F).
PFA, a thermoplastic material with a well-defined melting point, can be processed by means of transfer molding or injection molding. The granulate is melted in a melt pot or in the extruder and then forced into the hot tool by a hydraulic press.
This method enables very precise wall-thicknesses to be achieved, with tolerances of ? 0,5 mm, even at tight radii and in undercuts. Practically no mechanical finishing is needed, except to remove the sprue and to smooth the mating faces of flanges.
When using isostatic molding, however, a considerable amount of mechanical finishing is needed - depending on the degree of complication of the shape to be filled - to achieve the desired dimensions with precision.
The evenness of the wall-thickness may vary more, especially in the case of more complicated shapes such as valve housings.
Why use a PTFE (Polytetrafluoroethylene) instead of Rubber in a Rotary Shaft Seal?
PTFE Rotary Shaft Seals Outperform Rubber Shaft Seals
Elastomeric seals performed well for many years, but as the applications and environments became more demanding, elastomers had a hard time keeping up. If the application pressure is above 30 psi or the operating temperature goes above 275°F, elastomers simply don’t perform as well as, say, PTFE. (polytetrafluoroethylene). In this article, we are going to look at 3 areas where PTFE rotary shaft seals outperform rubber shaft seals.
Need more information on PTFE Rotary Shaft Seals? Check out these additional articles from the popular Advanced EMC Technologies Blog:
•Four Most Popular Rotary Shaft Seals Material Options and How They Compare
•Five Ways that PTFE Rotary Seals Differ from Elastomeric Seals
•Rotary Seals for Dummies: Four Questions about Shaft Surfaces for PTFE Rotary Seals
Wider Temperature Range
A major area that PTFE outpaces elastomeric seals is in its operating temperature range. As seen in the chart below, PTFE can function between -95°F to 480°F, far beyond any of its competitors in both cryogenic and high temperature applications.
Lower Friction
Friction generates heat, and heat buildup can be catastrophic to seals – resulting in unpleasant things like cracks or melting. PTFE has the lowest coefficient of friction of any solid material currently known, which is much lower than that of the elastomers typically used for seals. PTFE can also be used for dry running (i.e., without needing a lubricant), which elastomers cannot.
Better Chemical Resistance
PTFE is known for its chemical compatibility and excellent performance even in the presence of some of the most caustic chemicals out there. Rubber, however, has some limitations.
For example, Viton (FKM) is susceptible to ketones and acetones. EPDMdoesn’t perform well many oils and fuels, as well as hydrocarbons and concentrated acids. Nitrile (NBR) doesn’t do well in the presence of ozone, acetone, esters and ethers, or methyl ethyl ketone. Polyacrylatedoesn’t get along well with alkalines. In addition, elastomers aren’t really compatible with water, either.
Higher Speed Applications
As shown in the chart below, PTFE is the number one choice for high speed seal applications. In order or performance from low speed to high speed, we see Nitrile, Polyacrylate, and FKM (Viton).
Electronics and medical applications help PTFE glide to global growth
The Many Uses of Teflon, a.k.a., PTFE Industrial Coating
THE PROPERTIES AND ADVANTAGES OF PTFE
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PTFE A Miracle Material Evolves
In summary, different types of PTFE are available to meet the performance and economic requirements of a wide range of products and applications. Its unique properties can be enhanced with the addition of fillers, and it can be molded and machined into precision components. In addition, the material has been reformulated to make it more environmentally friendly while maintaining its basic characteristics — the characteristics that made it a miracle material when it was discovered in 1938 and still make it one today.
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