View Products & Services on Display at MD&M West 2008

Testing & Inspection/QA/QC

ADMET Inc.

Booth 648

ADMET offers a full line of low force static and dynamic testing systems for biomaterials, biomedical devices, plastics and other materials. ADMET's eXpert 560x and 760x electromechanical testing machines equipped with the ADMET Quattro controller and software are capable of cycling between force or position limits at speeds up to 15Hz. The high-speed closed-loop controller generates sawtooth, sinewave and other complex control profiles. Users can manually adjust control gains and end point values on the fly to ensure that test targets are being met. ADMET's 560x machines are user configurable to operate in a horizontal or vertical orientation. A full line of grips, fixtures, baths and ovens are also available.

Booth 1384

Adixen, H2000 Plus Hydrogen Leak Detector, and H2000 leak detector, by Alcatel Vacuum Products, use a safe hydrogen mixture as a trace gas. Sensitive to hydrogen and used to detect leaks that are smaller than bacteria. Using Non-hazardous 5 percent hydrogen in a 95 percent nitrogen mixture, it measures and pinpoints minute leaks independent of part temperature or volume. Maintenance-free as no vacuum pumps or valves are required. Dynamic background compensation minimizes potential problems with background interference assisted by the fact that hydrogen gas dissipates quicker than other gases. It features a standard probe with no sample suction.

Booth 1384

Adixen H2000 leak detector, by Alcatel Vacuum Products, uses a safe hydrogen mixture as a trace gas. Sensitive only to hydrogen it can be used to detect leaks that are smaller than bacteria. Using Non-hazardous 5 percent hydrogen in a 95 percent nitrogen mixture, it measures and pinpoints minute leaks independent of part temperature or volume. The electronic device requires no vacuum pumps or valves and is virtually maintenance free. Dynamic background compensation minimizes potential problems with background interference assisted by the fact that hydrogen gas dissipates quicker than other gases. It features a standard probe with no sample suction.

Booth 1857

Apple Rubber offers a full line of ISO 9001-2000 certified rubber parts and sealing solutions for industry with USP Class 6 grades available. In addition to silicone, Apple Rubber now offers medical-grade elastomers such as Viton® fluorocarbon (FKM) and EPDM rubber for medical applications. Complete engineering support, manufacturing, quality assurance and a Class 10,000 ISO Class 7 certified cleanroom are also available.

Booth 2832

Beta LaserMike supplies a full range of ID, OD and Wall measurement devices for the medical tube market, including these highly recognizable brands:
– DataPro: Process control
– Accuscan: Laser scanning diameter measurement
– Ultrascan: Ultrasonic wall and eccentricity measurement
– BenchMike: Off-line sample inspection
– LaserSpeed®: Non-contact length and speed measurement

Booth 764

Blue Mountain Regulatory Asset Manager is a comprehensive browser-based solution designed for regulated life science companies that enables the collaboration of maintenance, calibration and validation personnel. It allows asset owners, technicians, and managers to work together to maintain assets and processes in a controlled and validated state. In addition, the software reflects the reality that calibration, maintenance, and quality personnel each have their own unique requirements and ways of working with assets. Therefore, no group needs to compromise on productivity or compliance.

Booth 1421

Bose has introduced a unique series of multi-specimen test systems that can significantly reduce testing time and costs for developing fatigue life, (s/n) curves for NiTi, CoCr, and SS stent materials and structures.

ElectroForce 3200 & 3300 multi-specimen fatigue test systems are designed to provide tension-tension, or compression-compression displacement controlled loading for small soft structures and devices, such as stents, stent structures, stented grafts, vena cava filters, PFO closure devices or other similar devices.

The multi-specimen loading sites and temperature controlled saline bath are integrated into the proprietary servo-electric loading system to provide computer controlled testing for all loading stations.

Booth 2840

Sony TechnoLOOK 2008 New Video microscope systems model TW-TL1Z/10Z/15Z with zoom range 4.3x-43x/12x-120x/21x-211x integrated with super HAD CCD video camera and 10.4” LCD monitor display perfect for any medical device, SMT application. The new model is self contained unit directly save image to compact flash and provided with White Power LED light for natural color viewing. The price ranges around $6,500~$8,500.

Booth 741

CGI offers inspection systems and services for small injection molded parts with complex internal and external geometry. CGI’s patented cross sectional scanning technology often surpasses CMM and laser for first article inspections, failure analysis and reverse engineering. With spec. check, 3D point clouds reduce inspection time up to 75%.

Booth 2879

Digital Precision has introduced the DP1-IS video inspection system. The DP1-IS uses an XGA camera to connect directly to a VGA monitor for clear high contrast images. The XGA camera combined with the 5 to 34X Macro lens provides a high definition resolution and large depth of field.

Booth 1906

Dynatek recently released the Coating Durability Tester with Hyper Drive.
The company’s Coating Durability Tester utilizes Dynatek's Hyper Drive electromagnetic motor to produce and adjustable bellows compression at rates up to 150Hz, which allows for physiologically-relevant stent loading conditions at physiological or highly-accelerated rates. Upgrade options are available to existing machines upon request.

Booth 964

FasTest Inc. offers test connectors for ultra thin hypodermic and catheter tubing. The company has a smallest connector available for medical device leak test applications. Previously available for outside diameters down to 0.030”, FasTest’s new ME001 style connector is quickly connected to diameters down to 0.015”.

Capable of sealing down to 0.015" OD, the ME001 connector is designed for leak testing infusion set and drug delivery devices. The compact 0.84" OD easily mounts in limited space locations and the pneumatic actuation is ideal for soft touch control of delicate components or automation for ergonomics or high production testing.

Booth 262

Focalspot Inc.’s Verifier H series provides manufacturing quality assessment and defect detection of industrial, automotive and medical components and assemblies, such as: sensors, castings, electronic modules, electro-mechanical devices, pumps, inkjet cartridges, etc. The 4-Axis, 360° sample manipulator provides detailed quality inspection and defect analysis from nearly unlimited viewpoints.

The Verifier H comes standard with a PC-based VIP™ image processor, which provides tools for image enhancement, measurement, analysis, data collection and reporting. VIP makes use of configuration wizards to assist the operator in defining pass/fail inspection criteria, making the Verifier H exceptionally easy-to-learn and use.

Booth 2851

The P3K vision gauge was developed for accurate measurement of micro-devices in a production environment. It is equipped with a telecentric lens which yields a resolution of 0.00039”.
Customizable reporting feature producing pass/fail results in any combination of part measurement criteria. The P3K supports a wide range of measurement units including inches, mils, microns, and millimeters. It can read angular measurement in degrees and radians. Data collection capabilities include automatic statistical computation, average, median, standard deviation and CpK. Zooming, detailed diameter and length measurement are displayed on a 19" high-resolution flat panel display. Built on granite base for stability and accuracy.

Booth 1767

Glenbrook’s x-ray inspection systems offer compact, affordable versatility to meet laboratory or production requirements. Glenbrook’s MXRA® real-time x-ray camera has the high resolution and high sensitivity needed to image soft materials used in medical devices: polymers, rubber, ceramic and collagen.

Booth 2883

Helmel Engineering introduces the Microgage CMM, a small-format desktop 3-dimensional DCC instrument designed to deliver volumetric accuracy of better than 5.8µm with repeatability of 0.7µm, and scale resolution of 0.1µm. A fixed bridge type with moving stage for the Y axis, the unit has an XYZ travel range of 225x150x125mm. It features precision linear bearings in the X and Y axes and instrument roller bearings for the Z axis. Accuracy is intrinsic; error mapping and volumetric error compensation are not used. The Microgage is capable of dimensional inspection, scanning and reverse engineering of critical manufactured parts.

Booth 1269

World's First 54 Million Pixel 3CCD Digital Microscope

The new Keyence VHX-600 Digital Microscope with a 54 mega-pixel 3CCD provides exceptional image resolution and color accuracy. A depth-of-field 20 times greater than conventional microscopes and 3-D Image Composition combine to produce imaging quality and performance beyond most high-end optical systems. Includes on-screen measurements, counting, 3-D profiling and more. Targets can be freely observed with the camera/lens unit either handheld or mounted in the multi-angle viewing stand. The observation can be performed at all angles without manipulating the target, helping reduce time required for observation and avoid overlooking any defects.

Booth 1261

LaserLinc's new UltraGauge+T System provides non-contact measurement of wall thickness and eccentricity measurement using ultrasonic technology. The system can incorporate laser micrometers to offer complete in-process measurement of diameter, O.D., I.D., wall and eccentricity for plastic and other tubing, even multi-layer products.

Total VuT Software provided with the system includes real-time product cross-section display, color-coded measurement values, trending, SPC, flaw detection and data logging. Closed-loop control with Profit Maximizer can be used to automatically maintain product size and save material. An UltraGauge+ System will lead to improved quality, reduced scrap, material savings and better overall production efficiency.

Booth 2153

Lasersystems, IR Sources, and Gas Flow Sensors. LEISTER’s NOVOLAS™ system utilizes laser to precisely join plastic components. This non-contact, localized welding process eliminates abrasion & particulate and is an excellent method for microfluidic assembly. LEISTER’s Microsystem division, Axetris, produces IR Sources and Gas Flow Sensors. The IR Source is a thermal infrared emitter utilizing a micro-filament placed on a micro-machined membrane. The MFlow 200 provides fast and accurate measurement of gas flows in the 0 to 200 liter/min range. LEISTERS subsidiary IR Microsystems produces compact laser diode based gas detectors for CO₂, O₂, NH₃, etc., in medical, safety and process applications.

Booth 2885

Mahr Federal has introduced an innovative new Digimar® 817 CLM height measuring instrument with three distinct ways to initiate measurement. In addition to normal keypad initiation, a Quick Mode feature allows the measurement cycle to be initiated by simply pushing the carriage in the direction of the object to be measured. Also, two speed keys on the base allow the operator to comfortably move the measuring carriage to the desired position and start a measurement. Combined with an easy-to-program Teach-In Mode, these features can greatly reduce inspection time for a mini-series consisting of only a few test pieces.

Booth 1564

MasterControl Projects™ connects the project plan to assigned tasks, providing automatic updates as soon as tasks are completed. This module manages document-oriented or process-based tasks, including tasks external to MasterControl. It automates task assignment, routing, escalation, and tracking. Perhaps most importantly, it connects all the members of a project team, ensuring improved communication, better project control, and ultimately faster project completion.

Booth 2291

Cross-sectional scanning ("CSS") enhances Matrix's full-service package. This technology provides more comprehensive and accurate inspection data, including internal and difficult sectioned details, speeding up first article inspections. Parts are potted in special epoxy and while being milled away in thin slices, their profiles are simultaneously scanned. The result is a 3-D point cloud consisting of hundreds of thousands of measurement points capturing all features (external and internal) on every surface. This comprehensive point cloud data is aligned with the original CAD data. Color map software provides instant visual feedback via 3-D multi-colored images showing how closely the details compare.

Booth 3135

New SmartScope® Specialist™ 300 is an innovative benchtop metrology system offering micron-level measurements within a generous 300x300x250 mm of XYZ travel, to accommodate a multitude of parts. Specialist verifies critical dimensions of a wide range of medical parts from orthopedic implants such as intervertebral disc spacers and artificial discs; the stem, ball and cup of prosthetic ball joints; tibial and femoral knee implants; and tibial and talar ankle implants; to syringe components; to fluid flow components. A measurement routine for one part is easily repeated for a batch of fixtured parts, providing throughput to support production requirements.

Booth 3135

SmartScope® Flash™ 200 is an automatic benchtop multisensor dimensional measurement system with touch probe, laser and/or micro-probes for complete part characterization in one setup. Tactile probing measures difficult-to-image features, and through-the-lens (TTL) laser adds non-contact surface contouring. Feather Probe™ and Rainbow Probe™ offer micro-probing for miniature or delicate components. Flash 200 measures medical equipment components of any size, fragility, color, or opacity.
For video measurement, SmartScope® Flash™ 200 features a patented optics-tracking LED backlight; patented SmartRing™ white LED surface light for variable light direction and angle; and TTL coaxial surface illuminator. An auto-calibrating AccuCentric® zoom lens provides high-resolution optical imaging.

Booth 3135

The bridge-design SmartScope® Flash™ 500 multisensor dimensional measurement system features a 500x450x200 mm XYZ measurement volume and optional 300 mm extended Z-axis. It can be equipped with a new through-the-lens (TTL) laser, adding non-contact surface contouring to its already-strong touch probe, video, and micro-probe measuring ability. Flash 500 is configurable with the right sensors for almost any application, measuring a wide range of parts of virtually any material, softness, opacity, or color.
Easy-to-use OGP metrology software provides complete 3D functionality to take full advantage of a multisensing environment. Software options include form fitting, SPC, CAD translation, and custom report writing.

Booth 1515

New OPC Particle Sensor

To protect costly product, facility monitoring requires accurate, reliable particle monitoring equipment that provides easily accessible data. Used at top facilities worldwide, the Airnet particle sensor offers a small footprint, long life (MTTF of 144 months), and now comes with optional communication via an OPC server. OPC (OLE for Process Control) is an industry standard created with the collaboration of a number of leading worldwide automation and hardware/software suppliers working in cooperation with Microsoft. The organization that manages this standard is the OPC Foundation. With the addition of the OPC communications option to the Airnet particle sensors, installation costs are reduced for customers who have already have an OPC system in their facility.

Booth 1515

Particle Counter for Injectables

The APSS-200 parenteral syringe sampling system is designed to size and count suspended particles in a wide range of solutions, including injectables. This system meets and exceeds all current USP 788 requirements and is engineered to adapt to future regulatory changes. It also provides pharmaceutical injection monitoring to USP, BP, and EP standards.

APSS-200 is used for small and large volume injectable sampling. The SamplerSight software allows operators to manage the sampling requirements for batch-based operations and provides a comprehensive view of the batch information with histogram, time plot, and tabular data, presented in an easy to use format that can be simply reported.

Booth 1515

Lasair II 550L Air Particle Counter

This portable particle counter calculates and creates reports for EC GMP Annex #1, ISO 14644-1, and FS-209E testing and provides easy sub-sampling for ISO certification. Both ISO and EC GMP reports are generated from a single sampling run. The software walks the user through the process of GMP sampling, and then automatically generates a full final report. It has a comprehensive validation manual to meet the regulatory requirements of pharmaceutical manufacturers, making it easier to implement new technologies.

Booth 644

Innovative Digital Phase Technology from PhaseView is the easiest way for qualitative and quantitative 3D imaging.

MicroPhase is an affordable tool offering unique benefits: Optical Microscope Images; 3D Surface Topography; Simple Add-On compatible with any microscope; No additional accessories needed; Fast acquisition & processing time, less than 10 s; Accurate measurements in nanometer range; and Certified measurement device.

By replacing complex equipment for 3D visualization and measurement, GetPhase performs 3D reconstruction in a remarkably fast and easy way from a set of 2D intensity images. GetPhase provides comprehensive tools from automatic acquisition and processing to 3D analysis and reports

Web: http://www.quadtech.com

Booth 1524

Sentinel System:
.Fully automated, designed specifically for Medical Device Manufacturers (MDM)
.Built to customer specifications
.Scalable for current testing needs, expandable for future growth, minimizing future investments

CaptivATE Automation Software:
.Automate testing processes
.Collaborate on a global level
.Reduce production costs
.Collect data electronically
.Improve compliance with global regulatory requirements (IEC60601-1)
.Improve overall efficiency of manufacturing processes

Lead and Cable Testing Solutions
.Efficient, reliable and reproducible test systems
.Improve product quality and compliance
.Provide traceable test data
.Testing capabilities include: hipot, end-to-end continuity, capacitance and ESR measurements

Booth 2339

StarLite™ GX is a compact vision measurement system for medical device manufacturing and quality control. Automatically measure parts without the use of any motors. StarLite GX is a precision measurement system with quality zoom optics, sturdy cast aluminum construction, one-micron resolution scales, and three white light illuminators, its eGx™ metrology software provides accurate and repeatable dimensional measurements. Proven capability makes StarLite GX appropriate for use at all stages of the manufacturing process from R&D to final inspection. Measure more medical parts in a shorter amount of time.

Web: http://www.rmd-leadtracer.com

Booth 849

RMD Instruments, LLC manufacturers the LeadTracer-RoHS XRF instrument the most effective XRF system for RoHS compliance screening. LeadTracer-RoHS™ broad frequency/energy response of the elemental composition includes both the K-shell and the L-shell characteristic x-rays of desired elements.

LeadTracer-RoHS™ analysis of entire energy spectrum eliminates the limited capability of surface measurements by the x-ray tube XRF systems providing the “Big Picture” for RoHS Screening.

Booth 1851

Shimadzu’s EZ test series of tabletop testers features two base models: a short version with a 500mm stroke and a selection of load cells from 1N to 500N, and a long version with a 920mm stroke and a selection of load cells from 1N to 5kN. This versatility enables the configuration of up to 20 different units. Additional features include: crosshead speeds from 0.05mm/minute to 1,000mm/minute and load cell ratings from 1/1 to 1/250 with precision of +/- 1% of the indicated value. Optional TRAPEZIUM software provides simplified user operation with the industry’s premier navigation system

Booth 1492

Thermo Scientific NITON® XRF analyzers are the ideal tools for validation and verification of medical-grade alloys in the biopharmaceutical industry. These handheld instruments feature variable-spot size, the first-ever, fully-integrated, environmentally-sealed VIP™ tilting color touch-screen display for easy viewing in all lighting conditions, wireless Bluetooth™ or USB data transfer, IPC-1752 reporting, and component image storage for regulatory due diligence. They provide laboratory-quality RoHS screening capabilities with portable versatility.

With RoHS exemptions for certain medical devices expiring in 2010, NITON® XRF technology can make the transition to compliance manufacturing.

Booth 2242

Our portable IV tube set tester utilizes patented ultrafast mass flow technology. It is fast, easy to operate, and its functionality is traceable to NIST master parts. This model performs checks for:
• leak test
• occlusion (blockage) test
• valve installed in proper direction
Ideal for testing intravenous infusion set and components
• Complete IV Sets
• Valves
• Lubricators
• Drip Chambers
• Infusion Bags
• Flow Regulators
• Tubing
• Catheters

Booth 2242

VIC’s Multi-Lumen Catheter air leak detector incorporates a process-validation plan into your medical manufacturing process.
The Multi-lumen Catheter Leak Test System (MLC) provides an efficient and convenient way to validate up to 5 lumen catheters simultaneously. It uses dry air, or any gas, to automatically perform three tests on each lumen for:
• external leakage
• inter-lumen leakage
• flow test for occlusions
For greater productivity, a second station can be added to the MLC System so that one station is leak testing while the other is unloaded/loaded. Automatic removal of the fittings from the tester at the end of test is another option that accelerates the testing process.
• Fully-automated leak and flow test
• Easy to operate

Booth 1854

Vision Engineering introduces new Lynx LED illumination system. With latest developments in LED technology, this illumination is now available for Lynx stereo zoom microscope with enhanced performance; significantly reduced operating/consumable costs. Designed specifically for Lynx stereo Dynascopic microscope, LED illuminator offers improved performance at fraction of running costs of conventional halogen systems. Key benefits include: brighter, whiter 14-point shadow-free illumination; latest generation LEDs provide over 10,000 hours of continuous viewing; and, 80% reduction in consumable/maintenance costs. Together with patented ‘eyepieceless’ optics of Lynx, LED illuminator provides unrivalled comfort and clarity for a wide range of precision inspection and rework tasks.

Booth 1854

Vision Engineering introduces Merlin 300 – 2-axis video measurement system; sophisticated unit, exceptional price to performance ratio, and easy to operate. With consistent emphasis on measurement systems that offer excellent repeatability/reproducibility, Merlin 300 allows users to virtually “plug and play”. By offering video image solution to measuring parts, system increases accuracy/ repeatability by removing potential for operator error. Merlin 300 high performance, low cost package includes dedicated Quadra-Chek 300 video microprocessor with modern touch-screen technology including Video Edge Detection (VED). This package provides for fast, higher throughput measurements. With its compact footprint/high specification camera, also allows operators to easily determine component edge. Completing package: high numerical aperture objective lenses maximizing illumination efficiency; long life dimmable LED surface/sub-stage illumination.

Booth 756

Bigc.com offers the portable Dino-Lite digital microscope that provides high-quality microscopy video interfacing to PC with clear and steady imaging and 10X–200X magnification. The included software, DinoCapture, makes it easy and convenient to take snapshots, take video, manipulate images, and save and e-mail discoveries.

Web: http://www.zumbach.com

Booth 2014, 2526

ZUMBACH features its WALLMASTER OD/ID/WALL System with ultrasonic transducer holder, ODAC® 33 Trio 3-axis laser, and KW 32 Trio 3-axis gel detector on an American Kuhne extrusion line with Conair Medline Puller. The WALLMASTER will utilize its Bump Tubing Mode (BTM) to measure and alarm all critical parameters of bump tubing (OD/ID/WALL and length of "Tip" and "Body").

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