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Industry Intelligence

Leistritz Expands Twin-Screw Extrusion Process Laboratory

German extrusion firm Leistritz has completed an expansion of its twin-screw process laboratory in Somerville, NJ, USA. The facility now includes a controlled environment room for developing products for the plastics, medical and pharmaceutical industries. On-site equipment includes five twin-screw extruders, 20 feeders, and downstream systems for pelletization, film/sheet, laminates and profiles.
www.leistritz-extrusion.com

Hexagon AB Acquires French 3-D Software Company

Hexagon AB (Nacka Strand, Sweden) has entered into an agreement to acquire Technodigit SARL in Lyon, France. Technodigit develops 3DReshaper software, a software package that takes 3-D from scanning devices and allows point cloud processing, surface reconstruction and geometric shape extraction. The 3DReshaper application supports importing point clouds of unlimited size, mesh shaping and editing as well as 3-D surface comparison for inspection.
www.technodigit.com

PMC Medical Achieves ISO 13485 Certification

Contract manufacturer PMC Medical (Cincinnati, OH, USA) has announced that it recently has achieved certification to ISO 13485:2003. The company says that the certification is an example of one of the strategic steps it is taking to continue its growth in the medical device market. The certification comes on the heels of an investment of more than US$2 million in the firm’s medical business over the past two years. The manufacturer offers a variety of services including design for manufacturability, precision injection moulding, in-house assembly and packaging, and sterilisation management.
www.pmcsmartsolutions.com

Top Clean Packaging Opens Office in Netherlands

Medical and pharmaceutical packaging specialist Top Clean Packaging has opened an office in Sint Anthonis, Netherlands, which is a few kilometres from the German border. The opening of a new office is expected to support the firm’s growth in northern Europe and to facilitate its customer service offerings in northern Europe. Headquartered in Peschadoires, France, the company operates a total of five manufacturing facilities, which are located throughout Europe and Asia.
www.topcleanpackaging.com

AorTech Expands License Agreement with St. Jude Medical

Biomaterials specialist AorTech International plc (Surrey, UK) has announced the expansion of its license agreement with St. Jude Medical Inc. (St. Paul, MN, USA) for the use of its Elast-Eon biostable polymer in cardiac pacing and implantable cardioverter-defibrillator leads. This revised agreement extends St. Jude Medical’s exclusive rights into perpetuity and makes provisions for option payments on new polymer technology through 2012.
www.aortech.com

InterTech Receives ISO 17025 Accreditation for Leak Testing

Contract manufacturer InterTech Development Co. has announced that it has received ISO 17025 accreditation for leak testing at low flow rates. The ISO 17025 standard is used by testing and calibration laboratories to document the ability to consistently produce valid results. InterTech’s documented quality management system and related ISO 17025 accreditation is for leak testing at flow rates of 1 sccm. The company is also certified to ISO 9001.
www.intertechdevelopment.com

Outsource Manufacturer Ximedica Expands Manufacturing Facilities

Ximedica (Providence, RI, USA), an ISO certified and US FDA registered medical product development firm, has announced that it has added an additional 1500-sq-ft, Class 7 cleanroom to its headquarters in Providence, RI, USA. Ximedica provides outsourced research, design, engineering and contract manufacturing services. Within its 80,000-sq-ft facility Ximedica now has two Class 7 cleanrooms, a white assembly space and additional manufacturing space for kitting and other pilot production line assembly for both sterile and nonsterile medical devices and disposables. The new cleanroom will be equipped with ultrasonic welders, solvent and adhesive dispensing stations, pressure decay and vacuum decay testers and will use more then 25 HEPA filters while employing up to 20 employees.
www.ximedica.com

AdvantaPure Expands Silicone Moulding Operations

To meet increased product demand, tubing and hose manufacturer AdvantaPure (Southampton, PA, USA) has tripled the size of its cleanroom facility to allow for the increased production of moulded silicone components. The new space houses several liquid injection moulding stations used in the production of silicone manifolds, along with worktables, storage areas and an R&D station. A separate cleanroom, which was also part of the facility expansion, is used for manufacturing and packaging hose assemblies and for pressure testing. Access is restricted to essential team members in both HEPA-filtered rooms to maintain product purity.

AdvantaPure uses its expanded space to manufacture custom single-use silicone manifolds consisting of tubing; fittings in T, Y, cross and reducer styles; and other specified components. Sealing systems and stoppers are produced for flexible container systems, carboys, laboratory apparatus and bottles, and sampling and storage receptacles.
www.advantapure.com/molding.htm

PolyMedex Discovery Group Acquires Putnam Plastics

PolyMedex Discovery Group (Radnor, PA, USA), a privately held firm serving the medical device industry, has acquired Putnam Plastics Co. (Dayville, CT, USA) from Memry Corp. Putnam Plastics is a global supplier of coextruded, multilumen, braided and thin-wall, multilayer tubing. Memry Corp., now a subsidiary of SAES Getters International Luxembourg SA, had acquired Putnam Plastics in 2004. “This acquisition was a win-win for us and Getters,” according to PolyMedex Discovery Group co-CEOs Larry Acquarulo and Jim Dandeneau. “Combining these two companies allows us to provide more depth in polymer capabilities and support our customer’s efforts to provide better solutions for advanced patient care,” they explained in a press release. “Also, it allows SAES Getters to continue its commitment to shape-memory alloys for medical and industrial applications.”
www.putnamplastics.com

EaglePicher Medical Power to Open US Headquarters and R&D Centre

EaglePicher Medical Power LLC, a supplier of batteries to manufacturers of implantable medical devices, has announced that it plans to establish headquarters and a research and development center, in Plano, TX, USA. The 20,000 sq-ft facility will employ approximately 30 people. The on-site R&D centre will include laboratories and equipment for testing and manufacturing lithium batteries. The company currently operates two manufacturing operations and one R&D center in Joplin, MO, USA.
www.eaglepicher.com

BIT Group Unveils New Optics Lab

Global contract manufacturer of complex medical instrumentation BIT Analytical Instruments GmbH has announced that it has completed a redesigned optics lab, which has been optimized for operational and maintenance efficiency. The lab has been relocated to a climate-controlled facility in close proximity to the production department to facilitate access by production and R&D personnel. A cleanroom area has been established and additional laser safety equipment accommodates lasers up to class 3B. As in its former lab, BIT Group’s new lab is equipped with calibrated spectrometers, optical power meters and standard optics tools and systems used in constructing various test assemblies. Additional optics equipment and capabilities include photomultiplier units; photometers for turbidimetry and nephelometry; multicolor fluorescence microscopes; confocal microscopy; evanescent field technology; and high-resolution imaging.
www.group-bit.com