CORONA, Calif.—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.
Engel's Joachim Kragl explained a process-control system — iQ weight control — that derives essential process parameters from a machine's screw position and injection pressure curves. Engel says 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 will introduce iQ weight control commercially at the Schall organization's Fakuma trade fair Oct. 16-20 in Friedrichshafen, Germany. Previously, Engel showed the concept at a company symposium in June in Austria.
The iQ concept for part weight control is “one of the top five developments in machine software for repeatability in the last 10 years,” said Kragl, director of advanced molding systems and processing for Engel North America in York.
Engel's Steve Broadbent said the 2011 U.S. demand for silicone was $250 million with medical as the fastest-growing market from 2001 to 2011. He said that continued strong and steady growth in medical-product shipments would drive advances in silicone demand through 2016. Broadbent is Engel North America process engineer for elastomers and LSR.
Jerry Seidelman discussed in-mold labeling including how a 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. Seidelman is sales and marketing manager with Tech Mold Inc. of Tempe, Ariz.
Jan Nietsch talked about the Sigma inside concept of molding automation specialist Hekuma GmbH of Eching, Germany. The concept facilitates cavity-separated parts collection, shorter mold-open time than possible with free-falling parts and verification of parts removal to avoid mold damage. Nietsch is based in Laguna Beach, Calif., as Hekuma business development manager for the Americas.
Engel's Robert Herman 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. Herman in Schwertberg is sales manager for Engel's medical business unit.
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.
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.”
Engel's Tim Campbell reviewed the firm's e-factory 2 production-monitoring system 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. Campbell is an Engel service technician in Waterloo, Ontario.
Engel demonstrated three machines:
* A 110-ton hybrid tie-bar-less 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.'s Flint Hills Resources LLC unit makes in Longview, Texas, and distributes through partner PolyOne Corp. of Avon Lake, Ohio. The cycle time was 5.5 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 utilized Engel's x-melt process and a single cavity thin-wall mold in producing a polypropylene device cover; the system can process polycarbonate for a medical application. Incorporating a long flow time, the process makes use of energy stored 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, held Oct. 31-Nov. 1, and plans to show the same press during the MD&M West trade event on 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 plans to show 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 and conducted internal beta trials in late 2011. The e-mac is mechanically comparable to Engel's e-max machine, which has a LC200 controller. Engel aims to introduce the e-mac to the U.S. market in late 2013 and target California processors needing 50-110-ton clamping forces for medical molding. Engel said it will continue to make the e-max line available.
Engel opened the 7,200-square-foot Corona technical center in 2009 to serve the western United States and parts of northern Mexico. Engel Machinery's western U.S. region employs 16 including six sales people, nine service technicians and Jeff Hershey, regional sales and national accounts manager.