Toggle navigation. Casting Rubber Casting Rubber Parts. Different Industries. Silicone Rubber Tubing we are leading Serving Silicone Rubber Tubing based manufacturer, supplier of silicone rubber tubing of different shapes, and sizes required in different applications. In fact, we specialize in manufacturing different varieties that are required for serving different purposes.
Trelleborg Sealing Solutions manufactures a complete line of medical and food grade silicone products for the life sciences and processing industries that meet U. For added security, it is recommended that two ties be used at each attachment. Irrespective of the size of your business, we are here to help you as a real-time silicone rubber product manufacturer and trusted silicoen. Labor, numerous inventories, and time to assemble the manifold is unnecessary. Additionally, we tend to facilitate our clients to grow their business by perpetually supporting them in their ventures. Pre-cut lengths as short as mere fractions of an inch to many feet, cut to your Molded silicone tubin tolerance. Molded manifolds reduce the Molded silicone tubin of a wasted batch of costly product.
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In a cold deck scenario, the 1 to 1 mixed compound is pumped through Molded silicone tubin sprue and runner systems into a silcone cavity where the vulcanization takes Molded silicone tubin. Research and Development. Solve your assembly problems and reduce assembly Melanie crack whore confessions with 2-Shot silicone molding. Runnerless Molding Eliminate the time and resources traditionally needed for runner and bracket attached molds silicne runnerless molding. Rwanda S. The big difference between the two is cost and shape complexity. HPS silicone hose is available in both standard inches and hard-to-find Metric sizes. Request Information If you are looking for any information on our services, we can help! Product Information. Brunei Daruss.
Finding silicone rubber products and components that are custom made to meet your requirements can be quite a hectic task and time consuming, to say the least.
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We offer a broad range of silicones from all the major manufacturers. Best of all, we deliver all our products on time, on spec, and on budget. Freudenberg Medical offers custom extrusions in a wide variety of tubing types including multi-lumen, intricate cross sections, co-extrusion, wire coating, profiles, rods, tapes, and formed tubing. We apply an ISO medical device quality system to all production and inspection processes and include material certification and lot traceability with every product.
Pressure-proof polyester braiding, firmly embedded between two layers of silicone, lends this tubing its particularly durability and resistense to pressure. The tubing is individually packaged in pre-cut lengths of 7. The Tubing is available in red, green and white, individually packaged in pre-cut lengths of 15 m.
This ensure increased dosing precision in demanding applications. The tubing is individually packaged in pre-cut lengths of 15 m. A special production process designed to meet these requirements ensures that the products provide greater stability and capacity to withstand stresses.
The range offers sizes suitable for use with all commonly used pump types. This silicone undergoes a battery of biocompatibility tests appropriate for pharmaceutical applications, eliminating the costly extended implant studies typically performed on biomedical-grade silicones. The result: a more cost-effective silicone tubing that delivers consistent quality and the highest level of assurance.
Black-jacketed tubing is a custom extrusion offered by Freudenberg Medical. Material certification and lot traceability included in every package. The stoppers are suitable for all commonly used diameters and sizes and are supplied in packaged of We also offer stoppers with pre-drilled holes. The gaskets have exceptional biocompatibility and contain no contaminants or leachables.
Clamp gaskets are sterilizable by autoclave, ethylene oxide, or gamma radiation within validated cycles and exposure levels. Combine tubing, stoppers, and gaskets with complementary parts such as barbed tubing connectors, tri-clamp compatible fittings, or luer adapters. Options can include full preassembly or simply component inclusion. Whether you want to reduce bag and box waste or eliminate time-consuming cutting of tubing to specified lengths, Freudenberg Medical can accommodate your needs.
Consider our array of alternative packaging options, including:. Typical hardness: 65 Shore A. Add nonstripe and custom colors to create as complex a system as necessary.
Typical hardness: 50 Shore A. Typical hardness: 60 Shore A. For photosensitive drugs and light-sensitive fluids Black-jacketed tubing is a custom extrusion offered by Freudenberg Medical. Typical hardness: 80 Shore A. Custom Packaging A full array of options Whether you want to reduce bag and box waste or eliminate time-consuming cutting of tubing to specified lengths, Freudenberg Medical can accommodate your needs. Consider our array of alternative packaging options, including: Spooling amount on spool determined by tubing outside diameter.
Bulk coil packaging multiple standard coils in each box. Pre-cut lengths as short as mere fractions of an inch to many feet, cut to your specified tolerance.
Bluestar Silicones. Building the liquid silicone rubber molding. From Wikipedia, the free encyclopedia. Get A Quote. Applications Applications supported include feeding pumps, drug-dispensing equipment, catheters, diagnostic equipment, disposable fluid transfer manifolds and closure assemblies, filtration gaskets, dialysis machines and processing equipment.
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Molded Manifolds - Platinum Silicone - Biopharma TPE
Toggle navigation. Don Jahn, Dow Corning Corporation Silicone tubing and molded silicone assemblies are often employed in pharmaceutical and biopharmaceutical manufacturing processes to transfer high-purity fluids from one point to another, such as from tank-to-tank, from tank-to-filling machine or as a component in a single-use container or bioreactor.
Because the tubing and assemblies have direct product contact, it is important that users understand what impact the tubing and assemblies might have on their product. The following provides initial guidelines for biopharmaceutical and pharmaceutical manufacturers to consider when selecting silicone tubing and molded silicone assemblies or manifolds for use in product-contact applications. Physical Properties and Functional Performance A range of physical property and functional performance measures are available to characterize silicone materials.
Not all of these measurements are relevant to every application, but among the most relevant properties and measurements are: Tensile strength: Tensile strength measures the maximum amount of stress force required to stretch a material to its breaking point.
Tensile strength results are reported as force per unit area, such as pounds per square inch. Elongation at break: Measurement of "elongation at break," also referred to as "ultimate elongation," indicates how far a material may be stretched prior to rupture.
Elongation results are expressed as the percentage of the material's original length at rupture. Resilience and Abrasion Resistance: When tubing is used for an extended period in an application such as a peristaltic pump, the repeated flexing caused by the pump's rollers may cause the tubing to fail.
A relevant measurement that has been shown to correlate with the tubing's pump life is hysteresis loss measurement. Hysteresis loss measures the loss of elasticity as the result of stretching or flexing the material and is calculated from a stress-strain curve. Burst resistance: Application of intraluminal pressure to tubing or assemblies will cause these products to expand.
Exposure sufficient pressure will ultimately cause failure. Increasing the tubing wall thickness, using a different silicone elastomer formulation or using tubing with a reinforcing material such as polyester braiding can be effective methods of increasing burst pressure.
Effect of sterilization: Whether the tubing is sterilized by gamma radiation, autoclave, ethylene oxide, electron-beam radiation, or some other method, it is important to understand the impact of the sterilization on the tubing's physical properties and extractables profile.
This characterization may be achieved through comparing "before" and "after" measurements using the techniques described in this paper. Dimensional Measurements: Tubing is typically identified by referring to its inside diameter ID and outside diameter OD or wall thickness. An end-user should consider not only the nominal inside diameter of the tubing, but also the extent to which variability in ID, OD, or wall thickness are critical to their application.
Biological and Chemical Properties Although not specifically required by regulatory authorities, qualification by USP "Class 6" Biological Reactivity testing USP and is generally performed on materials intended for materials such as tubing and assemblies which come in contact with parenteral products. While the USP Class 6 battery of tests is generally considered necessary, it may not be considered sufficient by regulatory authorities.
A world class supplier of tubing and assembly products can often provide additional assistance to the end-user by providing in-depth toxicological data. In addition to the USP monographs for evaluating biological properties, a number of compendial references exist to characterize chemical properties of tubing and assemblies.
Leachables are compounds that can migrate into the drug product under normal conditions while extractables are compounds that migrate from a component such as tubing under extreme conditions such as elevated temperatures or through the use of aggressive solvents.
While the end-user is ultimately responsible for assessment and understanding of their finished product and the components which come into contact with the product, suppliers of components such as tubing and assemblies can often provide extractables data to aid in that assessment. A supplier of tubing and assemblies should be able to provide extractables data for solvents such as water for injection WFI , ethanol, and an organic solvent such as acetone.
A common leachables concern that is specific to peroxide-cured silicone materials is the presence of catalyst byproducts such as polychlorobiphenyl compounds. These byproducts are typically removed during an effective post-cure process, but the end-user should specifically consider the potential for these species when employing peroxide-cured silicone tubing or assemblies.
Supplier's Quality System It is important to select silicone tubing and assemblies from a producer that follows appropriate good manufacturing practices GMPs to aid the end-user in ensuring the safety, identity, quality, and purity of their drug products. Appropriate GMP elements should be implemented for the entire manufacturing and packaging process—from silicon to silicone—not just for the extrusion phase of the tubing.
If safety, quality, or purity of a drug comes into question, the drug manufacturer should be able to easily and fully document the integrity of the silicone materials through information readily available from the tubing and assembly supplier.
Understanding whether the supplier is registered with the US FDA or other regulatory agencies may be applicable, as is whether the supplier is registered to ISO Understanding how the supplier handles change control and change notification is essential.
The end-user should also consider the controls in place over the silicone elastomers used to produce tubing. The end-user should ask whether the tubing extruder produces their own silicone elastomers or purchases them. Regardless of the elastomer source, the end-user should understand whether the silicone elastomers were produced under principles of GMPs with traceability, change management and contamination control in a facility dedicated to the production of materials for the health care industry or whether they are produced in an industrial facility and simply qualified to USP Class 6 criteria.
Conclusion The accelerated adoption of single-use components by the pharmaceutical and biopharmaceutical industry has increased the need for drug manufacturers to develop an increased understanding of the various components with which their drug products come in contact. A range of silicone tubing and molded assembly products are available from a number of suppliers. By understanding the relevant means of characterizing tubing and assembly products, the end-user can best identify the silicone materials and supplier that can provide the quality products and associated data needed for their application.