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HelixMark®

A world of choice in silicone tubing and fluid handling products 

The world’s leading pharmaceutical and medical device companies rely on HelixMark® to deliver an extensive selection of high-quality silicone tubing and fluid handling products. Manufactured globally by Freudenberg Medical, HelixMark® products are available off-the-shelf in a wide array of product types and sizes. 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.

The choice of silicone you want

HelixMark® products are available with a choice of pharmaceutical-and medical-grade silicones made by industry leaders including Dow Corning and Wacker. 

The custom services you deserve

Custom ID/OD sizing, custom labeling and certification, and a variety of packaging formats are available including bulk, spooled, and cut-to-length. Additional custom services include skiving, pad printing, bonding/gluing, punching, drilling, parylene coating, proprietary striping, and rapiopaque. 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.

The quality standards you demand

HelixMark® products have been developed as a result of over 30 years of medical device manufacturing experience. We apply an ISO 13485 medical device quality system to all production and inspection processes and include material certification and lot traceability with every product. Our products meet USP Class VI biocompatibility requirements.

All HelixMark® products are manufactured in clean rooms in compliance with the requirements of the medtech and pharmaceutical industry.

The following criteria apply to all articles of this programme:

  • Materials approved in accordance with USP Class VI, ISO 10993-1, FDA 21CFR 177-2600 and EP 3.1.9 or EP 3.1.9 without appearance of solution
  • Exclusice utilisation of platinum-cured silicone
  • Production and packaging in ISO Class 8 clean rooms
  • Certified manufacturing in compliance with ISO 13485 quality standards
  • Sterilisable in autoclaves, with ethylene oxide and by gamma irradiation
  • Supplied with material certificate in every packaging unit
  • Seamless batch traceability
  • Double packed
  • Off-the-shelf availability guarantees short delivery times
  • Customer-specific solutions available outside the HelixMark® standard product portfolio

 

 

HelixMark® Standard Silicone Tubing

HelixMark®  Standard silicone tubing meets the needs of a broad spectrum of applications and are universally applicable for the transfer of fluids under standard requirements. The tubing is offered in two types of silicone (Dow Corning Silastic 50 Shore A and Wacker Elastosil 60 Shore A) and is individually packed in pre-cut lengths of 15 m.

For more information see our Size Chart.

HelixMark® Braided Reinforced Silicone Tubing

Ideal for increased pressure or high temperatures - HelixMark® braided reinforced tubing is designed and manufactured especially for applications with higher pressures. 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 7.5 m.

HelixMark® Braided Reinforced Tubing can be sterilized by autoclave, ethylene oxide, or gamma radiation within the user’s validated cycles and exposure levels.

Typical hardness: 65 Shore A.

For more information see our Size Chart.

HelixMark® Color Stripe Tubing

Recognize lines at a glance

HelixMark® Color Stripe Silicone Tubing is available with three choices of color striping: red, green, or white. Whether you want to recognize your lines at a glance by application, tubing size, or functional area, HelixMark® Color Stripe Tubing gives you the flexibility to create your own system.

Add nonstripe and custom colors to create as complex a system as necessary.

Typical hardness: 60 Shore A.

HelixMark® colour-striped tubings helps to maintain a clear overview in complex tubing systems and enables quick and easy identification of individual applications, sizes of functional configurations. The Tubing is available in red, green and white, individually packaged in pre-cut lengths of 15 m.

For more information see our Size Chart.

HelixMark® Close Tolerance Tubing

HelixMark®  close tolerance silicone tubing maintains particularly tight tolerances with regard to inner diameter and wall thickness and is subjected to stringent quality assurance measures in production. This ensure increased dosing precision in demanding applications. Biomedical/pharmaceutical-grade platinum-cured silicone tubing, manufactured with Dow Corning, provides superior flow properties. HelixMark® close tolerance silicone tubing ensures minimal dimension variation, making this tubing appropriate for the most exacting applications. Sterilize HelixMark® Close Tolerance Silicone Tubing by autoclave, ethylene oxide, or gamma radiation within validated cycles and exposure levels. The tubing is individually packaged in pre-cut lengths of 15 m.

Typical hardness: 50 Shore A.

For more information see our Size Chart.

HelixMark® Peristaltic Pump Tubing

HelixMark® peristaltic pump tubing is designed and manufactured for use with peristaltic pumps and other applications with higher effective forces. 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. The tubing is individually packaged in pre-cut lengths of 7.5 m.  

Typical hardness: 60 Shore A.

For more information see our Size Chart.

HelixMark® PharmaFocus® Tubing

HelixMark® PharmaFocus tubing is manufactured from a platinum-cured silicon that was developed especially to meet the needs of the pharmaceutical industry. 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. The tubing is individually packaged in pre-cut lengths of 15 m.

Typische Härte: 50 Shore A.

For more information see our Size Chart.

HelixMark® Black Opaque Tubing

For photosensitive drugs and light-sensitive fluids

Black-jacketed tubing is a custom extrusion offered by Freudenberg Medical. The tubing is manufactured to your exact specifications (ID/OD sizing and packaging format) and contains an opaque exterior layer to block all light without touching the fluid path. HelixMark® Black-jacketed Tubing is ideal for photosensitive drugs and light-sensitive fluids.

Black-jacketed Tubing is available with a choice of Dow Corning, Wacker, Nusil, Momentive, or Blue Star USP Class VI silicones. Material certification and lot traceability included in every package.

HelixMark® Silicone Stoppers

HelixMark® silicone stoppers enable reliable sealing of glass tubes, vials and flasks. The stoppers are suitable for all commonly used diameters and sizes and are supplied in packaged of 12. We also offer stoppers with pre-drilled holes.

Typical hardness: 50 Shore A

For more information see our Size Chart.

HelixMark® Silicone Clamp Gaskets

HelixMark® pharmaceutical-grade Silicone Gaskets are made with our proprietary molding process and engineered to be consistently free of crevices and protrusions. 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. HelixMark® clamp gaskets ensure reliable sealing of radial plug-in connectors. The gaskets are suitable for all commonly used diameters and sizes and are supplied in packages of 25.

Typical hardness: 80 Shore A.

For more information see our Size Chart.

Custom Services

Excellence is customary

Custom Assemblies

Dedicated to saving time

Utilize Freudenberg Medical’s dedicated assembly expertise to free up valuable employee time. 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.

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).