MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, September/October 2015

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M E d I c A L P r O d u c t M A N u f A c t u r I N g N E w S q M e D . c o M / M p M n 1 0 S E P t E M b E r / O c t O b E r 2 0 1 5 MD&M MINNEAPOLIS 2015 ground by the company include thin- walled hypotubes; complex guidewires with square, helical, triangular, and fat shapes ground in; very-high- precision mandrels and core pins; catheters; and other high-precision implantable-device components. In addition, it grinds a variety of polymeric materials. Service to customers involves a consultative problem-solving approach. ■ Meron Medical wArMINStEr, PA www.meronmedical.com Booth #1457 Low-Foaming Detergents Alcojet low-foaming powdered detergent is designed to be a high performance cleaning agent for use in small-parts washers such as are employed by medical device companies, and Solujet low- foaming phosphate-free liquid and citranox liquid acid cleaner and detergent both provide low-foaming concentrated detergent options for larger washers used in medical device manufacturing. these aqueous free- rinsing detergents from Alconox Inc. are engineered to leave parts free of oily residues, inorganic acid-labile compounds, and other contaminants. In addition, the supplier offers a spectrum of emulsifying detergents for various manual cleaning applications in medical device manufacturing. Also available is a low-foaming ion-free detergent suitable for cleaning electrical and electronic medical device components via manual or automated methods. It contains no chelating agents, halides, or conductive metal cations and can be used to remove rosin fux and to clean Pcbs thoroughly and safely. ■ Alconox Inc. whItE PLAINS, NY www.alconox.com Booth #1339 Test Method Validation ddL Inc. offers test method validation services to medical device manufacturers and developers. test method validation is the documented process of assuring that a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and identifying infuences that may change those characteristics. the range of validation services provided by the ISO 17025–accredited third-party testing facility includes protocol development, test execution, data analysis, test reports, and test method development. clients can use these services during the early stages of product development, during execution of testing, or as part of a full test method development and validation process. the service provider additionally tests medical devices, device materials, device packages, and packaging materials, performing accelerated-aging tests, distribution simulation, testing of package strength, integrity, physical shock, thermal shock, vibration, and compression, and unitized load testing, along with other validation services. ■ DDL Inc. EdEN PrAIrIE, MN www.testedandproven.com Booth #845 Low-pressure Stopcocks three low-pressure stopcocks, catalog numbers 99770 through 99772, are stocked by the OEM disposable component supplier Qosina corp. their tinted polycarbonate body provides lumen clarity, and a white high-density polyethylene (hdPE) handle allows for smooth movement in changing fuid fow direction. Equipped with an hdPE rotating male luer lock that minimizes tube kinks and enables full rotation, the stopcocks have two female luer locks that mate with any ISO 594 standard connection. the single-use components are offered in two-, three-, and four-way confgurations and are compatible with EtO and gamma sterilization conditions. they can withstand pressures up to 43 psi. Stopcock sample kits available for testing purposes contain various confgurations, pressure ratings, handle rotations, and colors. ■ qosina corp. EdgEwOOd, NY www.qosina.com Booth #920 pneumatic and Automation components Manufacturers' representative Air Engineering and Supply distributes pneumatic and automation components for medical OEM applications. the company represents the actuator and valve manufacturer clippard Instrument Laboratory Inc., as well as several other manufactures that produce aluminum extrusions, electric motors, panel products, machine safety components, pneumatic cylinders, valves, vacuum products, fttings, tubing, and sensors and accessories. It also provides value-added services for OEM ac-dc motors, assistance with product selection and design, and subassembly and complete assembly services. ■ Air engineering and Supply MINNEAPOLIS www.airengr.com Booth #1426 Thermoplastic compounds beahm designs Inc., a producer of catheter manufacturing equipment, offers the Stripper, a suite of three tabletop tubing-litter products suited for use in both r&d and mass production. designed to accelerate and simplify an otherwise labor- intensive process, the production tools eliminate the need for manual removal of waste connected with thermoplastic tubing that has been laminated or refowed, and thus prevents damage to the underlying catheter. A guide pin slides between the heat-shrink layer and over the laminated product. As the shaft subassembly is advanced, the heat-shrink layer is guided into a blade that creates a longitudinal slit through the heat-shrink, thus facilitating peel-away removal. the fxture's guide and blade height adjusts to accommodate tube diameters from 0.040 to 0.25 in. as standard, with larger sizes available upon request. the specialized blades offer hardness, corrosion resistance, and a chemically inert, naturally nonstick surface that compare favorably with features of traditional stainless-steel blades. ■ Beahm Designs Inc. MILPItAS, cA www.beahmdesigns.com Booth #1733 check Valves the b. braun OEM division of b. braun Medical Inc., an fdA- registered, ISO 13485–certifed provider of contract manufacturing services and of components for medical devices, offers normally open low-pressure check valves in standard and custom options. these valves are designed to prevent the backfow of fuids into the primary IV container during piggyback hookup or bolus injection. they operate with gravity- fow pressure for optimal shutoff performance. the valves feature a low back pressure of 6.75 in. h2O maximum to reseal and a high back pressure of 30 psi. Lipid resistant and containing no natural rubber latex in their construction, the components are available as a bulk nonsterile product or ready for integration into a custom fuid-administration set. ■ B. Braun oeM Div., B. Braun Medical Inc. bEthLEhEM, PA www.bbraunoem.com Booth #1132 canted coil Springs Medical device engineers and designers can get detailed information about ways canted coil springs can be used to address challenges regarding shielding against electromagnetic interference and radio-frequency interference (EMI/rfI) from a downloadable 10-page catalog published by bal Seal Engineering Inc. the literature describes how the company's compact, precision- engineered springs can protect sensitive electronics from the harmful effects of EMI/rfI, particularly in high-frequency small-package applications. Available in a variety of coil heights, wire materials, and types of plating, the springs maintain a nearly constant force over a broad compression range, compensating for angular misalignment, surface irregularities, and even temperature changes without signifcant deviation from the initial force. Each coil works independently, maintaining contact with the mating surface and thus maximizing conductivity. the durable, versatile springs resist compression set, and their locking, latching, and holding properties enable designers to meet specifc requirements for insertion and breakaway force. ■ Bal Seal engineering Inc. fOOthILL rANch, cA www.balseal.com Booth #1148 enterprise Resource planning Software IQMS, a developer of enterprise resource planning (ErP) software and manufacturing execution systems, has introduced features in its EnterpriseIQ software designed to resolve two manufacturing challenges: the desire to grow capacity without increasing resources and the need to adhere to strict industry compliance and regulatory standards. using automation as provided by the ErP system's native planning, scheduling, and process monitoring modules, manufacturers can add capacity using only existing plant and equipment. real-time automation functions instantaneously collect production data and relay the information to the ErP system for tracking and analysis, enabling manufacturers to adapt production schedules to real output in real time. the scalable single-database enterprise software system helps manufacturers cope with compliance, risk management, and quality control challenges by offering an end-to-

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