Surface Treatment

Lubricious Coating Developed for Stainless-Steel Medical Devices

Becomes ultraslippery upon contact with body fluids

Easy and safe manipulation of invasive stainless-steel guidewires and other metalbased medical devices is possible with an improved lubricious coating. Developed by STS Biopolymers Inc. (Henrietta, NY), Slip-Coat is thin and flexible and adheres to both wet and dry metal substrates. It is also permanent and nonthrombogenic and has a smooth, nonslip feel when dry. Immediately upon contact with bodily fluids or water, the coating becomes ultraslippery, reducing friction and increasing a physician's ability to control the guidewire during insertion.

Through the use of the Slip-Coat formula, biocompatibility can be achieved at a low cost without changing the materials from which the devices are made. According to STS, earlier formulations have been used successfully on various polymeric, titanium, and nitinol medical devices, including both vascular and urinary catheters, urinary stents, and guidewires. Therefore, the formula is suitable for use in cardiology, radiology, neuroradiology, and urology procedures.

STS specializes in the development, manufacture, and application of medical device surface treatments. Its products include lubricious, antithrombogenic (various heparin complexes), antimicrobial/antibiotic, and nonconductive biocompatible coatings. The coatings can be formulated for short-, intermediate, or long-term effects. Coating services include plasma pretreating, coating application, and development of custom coating technologies. Related services include packaging and sterilization (EtO and steam) and such testing services as biocompatibility, ISO, USP, bioburden, sterility, residuals, shelf life, and package integrity.

For more information, contact STS Biopolymers Inc. at 716/321-1130.

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Inspection

Luminescence Detector Reads Invisible UV Markings

Can be used to confirm bonds in medical assemblies

BALLUFF INC. (Florence, KY) has developed a luminescence detector that reads invisible UV markings on various materials to verify critical processes, provide presence and position sensing, enhance quality control, and perform part counting and product ID. The detector is well suited for maintaining quality control of critical operations such as confirming bonds in medical IV and catheter assemblies. Mixed into adhesives, solvents, and sealants, the invisible UV markers confirm that items have been correctly coated and joined. The device can also be used to inspect packaging lines.

The detector provides high reliability and process control with black or dark objects that do not reflect as well as materials with high reflectivity--such as mirrors, glass, and chromium plating--which present problems for other optical sensors. The unit emits UV light on a 350-nm wavelength. The UV light is converted to visible light upon striking a luminescent object or mark. The reflection is then detected by the unit's receiver through a special filter that sees only visible light in the 450 to 700-nm range, making the detector totally insensitive to other light sources.

The detector can be configured for operating distances from 5 to 80 mm and spot diameters from 3 to 25 mm. A red LED indicates signal output, and DIP switches allow selection between three output logic functions--normal, memory, or one-shot output. Use on high-speed production lines is permitted by a response time of one millisecond and 500-Hz switching frequency. The units operate on 10- to 30-V-dc supply voltage. Average lamp life is 8000 hours, and lamps can be replaced with the unit on-line.

For more information, contact Balluff Inc. at 606/727-2200.

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Sterilization

E-Beam Sterilization System Designed for In-House Use

Can be integrated directly into manufacturing process

TITAN SCAN SYSTEMS (San Diego) has developed an E-beam sterilization system that enables medical device manufacturers to benefit from on-site processing of their products.

Designed for in-line or end-of-line sterilization, the SureBeam system can be integrated directly into the device manufacturing process. Unlike other sterilization technologies that use gamma or EtO, the E-beam technology eliminates the handling, transportation, and storage of radioactive isotopes and materials.

In-house sterilization can eliminate costs associated with handling, inventory, labor, and transportation to and from off-site sterilization ontractors. In-house sterilization also supports just-in-time manufacturing and other supply-management goals.

The SureBeam can sterilize individual devices at high volumes or process bulk products in their final packing cartons. Small enough to fit into existing production facilities, the system can also be relocated to support changing production needs.

The SureBeam requires less than 600 sq ft of space and is delivered fully operational. Titan provides total support for its use, including installation, regulatory validation, operational procedures, and ongoing service. Preengineered modules in the system include an E-beam accelerator, material-handling equipment, a self-contained shielding and safety system, and a SureTrack control system.

For more information, contact Titan Scan Systems at 800/438-1423.

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