Originally Published EMDM January 2006
Product Update
Focus on suppliers of tubing
Saint Gobain PPL Gessil
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Designed for critical medical applications, recently introduced DEHP-free tubing is reportedly the only product of its kind for extracorporeal membrane oxygenation procedures. The tubing is suited for use with dialysis and peristaltic pumps, and with blood and IV solutions. Tygon ECMO tubing is available from Saint-Gobain PPL Gessil (Saint Quentin Fallavier, France).
The biocompatible material from which the tubing is made withstands EtO and gamma sterilization and resists chemicals. It has been subjected to rigorous testing to ensure spallation is minimal when it is used with peristaltic pumps, and the tubing is undergoing ISO 10993 testing to facilitate validation.
Tygon ECMO has been found to be nonpyrogenic and nontoxic in systemic toxicity, intracutaneous reactivity, cytotoxicity, haemocompatibility, and intramuscular implant testing.
Popper & Sons
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Precision hypodermic Types 304 to 316 stainless-steel tubing is supplied in a variety of gauges. Popper & Sons (New Hyde Park, NY, USA) also manufactures tubing to customer specifications.
The company uses advanced technologies for cutting and grinding tubular components. In particular, it employs electrochemical cutters to achieve burr-free cuts with extreme accuracy at minimum 0.100-in. cutting lengths and very small gauges.
In addition to all varieties of 300-series stainless steel, the firm processes titanium, Inconel, and other alloys. Services include swaging, bending, flaring, tip reducing, coiling, EDM, CNC turning, and laser welding. Laser engraving, surface finishing, and wire bending and forming are also offered.
MicroGroup
Custom and stock stainless-steel tubing is available in metric, fractional, hypodermic, and nonstandard sizes and shapes. MicroGroup (Medway, MA, USA) pledges that it can supply the products anywhere in the world within two weeks.
Depending on the material grade and configuration, stainless-steel tubing can be manufactured in sizes ranging from 0.8128 to 50.8 mm diam with wall thicknesses as small as 0.1270 mm. Tolerances are in the ±0.0254-mm range. Available in precisely engineered square, rectangular, and oval shapes, the custom redrawn tubing can be made from 304- and 316-series stainless steel and nickel-based alloys. Prototype to production quantities can be supplied.
Pexco Medical Products Div., Filtrona Extrusion
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Solvent-bonded paratubing offers comprehensive control of pull and peel strength and can be produced in a range of diameters to fit custom components. Because the tubing is manufactured in a single operation, it is more cost-effective than competing products, according to Pexco Medical Products Div., Filtrona Extrusion (Northborough, MA, USA). Two recent applications in which PEXbond paratubing is used illustrate the product’s versatility.
Paired PEXbond tubing and paired electrical conductors are used in the NovaSure impedance controlled endometrial ablation system for women who suffer from excessive menstrual bleeding. The smaller of the two tubes is used to insufflate the uterus cavity with CO2 to check for uterine cavity integrity, while the larger tube supports a moisture vacuum system.
Pexco products are also used in a quad tube design for a breast biopsy device. The tubing delivers irrigation and anaesthesia to the biopsy site while providing air and suction to capture tissue. The Atec device from Suros Surgical Systems enables the performance of rapid nonsurgical biopsies.
Degania Silicone Europe
A supplier of silicone products for medical applications offers a comprehensive range of standard tubing. Degania Silicone Europe (Regensburg, Germany) also routinely supplies tubing designed to meet specific customer requirements.
USP Class VI and long-term implantable materials are routinely processed. The company provides cutting, punching, printing, and coating services, and it supplies finished sterile products such as catheters and wound drains. Foley and suprapubic catheters, as well as products in customer-specific configurations, are available.
In addition to extrusion, the firm provides balloon moulding and dipping services. Two-layer balloons can be mounted on PVC shafts. The company also has expertise in embedding antimicrobial and other protective agents into catheters. Its quality systems are certified to ISO 9001 and ISO 13485.
Applied Plastics
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PTFE coatings can be applied onto stainless-steel and nitinol hypodermic tubing without altering a product’s physical properties. Applied Plastics (Norwood, MA, USA) can apply the lubricious coating to the outer diameters of hypotubes in tolerances required for smooth arterial transfers. It is available in green, grey, black, and blue.
Marker bands can be placed at user-specified intervals. The company’s coatings are suitable for spiral, skived, flared, crimped, ground, and slotted types of hypodermic tubing. The firm can also source the tubing if the customer so desires.
Solvay Draka B.V.
Film and tubing supplied by a firm that is a branch of one of the 10 leading chemicals companies in Europe is suited for the manufacture of IV bags and administration systems designed to contain blood, parenteral nutrition, cell cultures, and infusion and dialysis fluids. The line of semifinished medical products is marketed under the Solmed name by Solvay Draka B.V. (Enkhuizen, Netherlands).
Solmed PVC film and tubing does not contain animal-derived ingredients ensuring that it is not a carrier of transmissible spongiform encephalopathy. The products are manufactured under cleanroom conditions in accordance with GMP guidelines. Raw materials, intermediates, and final products are thoroughly tested in the company’s laboratories based on a number of parameters including cell survival toxicity. Test results are recorded on a certificate of analysis and are supplied with every pallet of material. Batch and reel numbering ensures traceability during every phase of production; the records and reference samples are stored for 10 years.
Compounds are developed to meet customer specifications as well as national standards and pharmacopoeia. The company’s master file has been registered in the United States, Japan, and many other countries worldwide.
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