Polymers and processing technologies play a key role in future development of health-care products.
An aging population and increasing demand for treatment of diabetic, cardiovascular and respiratory conditions drive the global market for medical devices and equipment.
Engel Machinery Inc. of York, Pa., explored that market through an Oct. 2-4 symposium at its Corona technical center addressing issues in the molding of thermoplastics and liquid silicone rubber for medical applications.
Joachim Kragl, director of advanced molding systems and processing for Engel North America in York, explained a process-control system — iQ weight control — that derives essential process parameters from a machine's screw position and injection pressure curves. Engel said the system compensates for short- and long-term quality deviations and results in sustained improvement in repeatability.
The idea originated with Georg Pillwein, a physicist and project engineer in the process development technology department at family-owned parent firm Engel Austria GmbH in Schwertberg, Austria.
Engel was to introduce iQ weight control commercially at the Fakuma trade fair, held Oct. 16-20 in Friedrichshafen, Germany. Previously, Engel showed the concept at a company symposium in June in Austria.
The iQ concept is “one of the top five developments in machine software for repeatability in the last 10 years,” said Kragl.
Steve Broadbent, an Engel North America process engineer for elastomers and liquid silicone rubber, said the 2011 U.S. demand for silicone was $250 million, with medical as the fastest-growing market from 2001-11. Continued strong and steady growth in medical-product shipments will drive advances in silicone demand through 2016, he said.
Robert Herman, sales manager for Engel's medical business unit, reviewed the value of strict-separation techniques in clean room molding of medical devices. The separations involve input-output, delivery dispatch, material air locks and personnel air locks.
Jerry Seidelman, sales and marketing manager with Tempe, Ariz.-based Tech Mold Inc., discussed in-mold labeling, including how forensic coding — visible to a sensing device but invisible to the naked eye — can be placed in a label. The coding aims to combat the market potential for counterfeit products.
Jan Nietsch, business development manager for the Americas for molding automation specialist Hekuma GmbH of Eching, Germany, talked about the firm's Sigma inside concept. The concept facilitates cavity-separated parts collection, shorter mold-open time than is possible with free-falling parts, and verification of parts removal to avoid mold damage.
Sabic Innovative Plastics reiterated needs concerning health-care products and cited how the firm is responding.
Greater global agency oversight can enhance the safety of medical devices, packaging and drugs, said Lori Boechler, senior sales development leader in San Diego with Sabic. She was referring to regulations and laws relating to the U.S. Food and Drug Administration, European Union food-contact oversight and Chinese state food and drug administration.
Pittsfield, Mass.-based Sabic said it pre-assesses biocompatible materials for conformance or compliance with a manufacturer's final tests, and the resin supplier seeks to avoid formula changes to “help minimize the potential for a resin's chemistry to be the root cause of a medical-device non-conformance or non-compliance.”
Also during the symposium, Tim Campbell, an Engel service technician in Waterloo, Ontario, reviewed the firm's “e-factory 2” production-monitoring software that was released in May as a successor to e-factory 1 software. The new system runs on a server, collects process data, manages mold setups and can connect with the injection molding machines of other manufacturers through protocols of the Euromap 63 data-exchange interface.
Engel demonstrated three machines during the symposium:
* A 110-ton, hybrid, tie-barless e-motion 310 LSR press with all-electric injection and servo-hydraulic clamps ran a 16-cavity mold from Tech Mold in making a long, thin, 5-cubic-centimeter syringe barrel. The material was clarified 13T25A random copolymer polypropylene that Koch Industries Inc. makes in Longview, Texas. The cycle time was 51/2 seconds.
* A 55-ton e-victory 200 LSR press with a servo-hydraulic Ecodrive system ran a four-cavity mold and dosing system, both from Elmet North America Inc., in manufacturing an LSR nasal prong of 50-durometer LSR from the eight-resin-grade, platinum-catalyzed, heat-cured QP1 material series of Midland, Mich.-based Dow Corning Corp. The cycle time was 29 seconds.
* A 60-ton all-electric e-motion 200 press used Engel's x-melt process and a single-cavity, thin-wall mold to produce a PP device cover. The system can process polycarbonate for a medical application. Incorporating a long flow time, the process makes use of energy stored by the highly compressed melt up to 40,000 pounds per square inch in the space in front of the screw. The cycle time was seven seconds.
Engel also demonstrated a fully integrated water manifold system, named Flomo, on the 110- and 55-ton presses.
Kragl said Flomo with Vortex sensors replaces a previous Engel flow-monitoring system from several years ago. “It was sold twice and was too expensive for the market,” Kragl noted.
The current, compactly designed Flomo water manifold enables electronic process monitoring of all cooling units.
Engel's integrated three-axis servo Viper robot removed the nasal prong and the device cover from, respectively, the 55- and 60-ton presses.
Engel shipped the demonstration e-victory 55 from Corona to Minnesota for the UBM Canon Medical Design and Manufacturing Minneapolis exhibition, slated for Oct. 31-Nov. 1, and plans to show the same press during the Medical Design & Manufacturing West trade event Feb. 12-14 in Anaheim, Calif.
Engel found eager reception for in-depth training on LSR equipment.
The scheduled third day for the symposium was oversubscribed. The focused, hands-on program covered technical details including the maintenance and assembly of dosing systems and injection units and the systematic approach to developing stable LSR process startup and monitoring.
Engel set a registration limit of 12 — and allowed 13 — for the LSR training. Fifty people wanted to attend. Engel plans to schedule additional LSR programs in Corona to train those unable to be accommodated on Oct. 4.
At the Fakuma show, Engel displayed an e-mac press initially for the European market. The intention is to supply an electrical line that is priced like a hydraulic and has a reengineered CC200 controller.
Engel started e-mac development in early 2011. The machine is mechanically comparable to Engel's e-max, which has a LC200 controller. Engel will introduce the e-mac to the U.S. market in late 2013 and target California medical molders needing clamping forces of 50-110 tons. Engel said that it will continue to make the e-max line available.
Engel opened the 7,200-square-foot Corona tech center in 2009 to serve the western U.S. and parts of northern Mexico.