Corona, Calif. — Requirements for medical molders are changing, with suppliers taking on more responsibility.
At the same time, new technology and automation are changing what is possible to do on the shop floor in multiple industries.
To provide an overview of outsourcing, consolidation and market complexities, Engel Holding GmbH hosted a U.S. regional symposium at its recently-upgraded Corona technical center. Engel is based in Schwertberg, Austria, with U.S. operations based in York, Pa.
The first day of the March 8-9 event focused on the medical market, with packaging in the spotlight on the second day.
Robert Schwenker of Saint-Gobain Performance Materials Corp. talked about how medical device companies pursue strategies to outsource their quality and regulatory risks to suppliers.
The new ISO 13485:2016 standard “explicitly requires an organization to comply with all regulations by 2019,” said Schwenker, business manager for medical components in Austin, Texas, with the corporation’s fluid systems business.
He discussed increase in warning letters — and unscheduled inspections — by the U.S. Food and Drug Administration.
Schwenker tracked the increased regulatory oversight from 2002’s first-article inspections to 2017’s validation programs for equipment, facilities and defined projects.
Schwenker said: “Saint-Gobain wants to anticipate what regulatory systems are saying” as evolving requirements impact more medical device subcontractors and components providers.
In October, Saint-Gobain completed extensive renovation of a Gaithersburg, Md., facility to design, develop and make disposable single-use systems for the cell therapy market.
The performance plastics business is a unit of Paris-area-based Saint-Gobain SA.
Mergers and acquisitions executive Perry De Fazio reviewed recent health care industry consolidations that he said create “a highly advantageous environment for contract manufacturers.”
De Fazio is vice president of private equity firm Covington Associates LLC in Boston and previously spent 15 years as an engineer in medical device research and development.
Market drivers are bringing more value to Tier 1 and Tier 2 contract manufacturers, borrowing terms more commonly used in the automotive industry’s supply chain. In many cases, De Fazio noted, the change is beginning to confine traditional health care OEMs to the sales and distribution functions for their products.
An Italian maker of automation equipment and turnkey solutions perceives a demand for high flexibility in the European market and faster redesign of products.
“The solutions are becoming more complex,” said Marco Marconi, sales area manager with Campetella Robotic Center srl in Montecassiano, Italy. “The time-to-market factor is really important.”
Marconi stressed the importance of bringing all functions together at the start of a project. Players include the injection molding machine manufacturer, mold maker, label producer, in-mold-label processor and packaging machinery firm.
Marconi said Campetella will get a new factory of about 91,000 square feet. The business employs 94 and, during 2016, installed 350 robots with 20 percent of the deliveries in Italy and the remainder elsewhere.
Engel’s Joachim Kragl outlined the values of the firm’s iQ weight control processing software in pushing the boundaries of machine intelligence. Kragl is Engel North America’s director of advanced molding systems and processing.
With iQ weight monitoring, “corrections are done in real time in the same cycle” resulting in “consistency in parts” through the “utmost repeatability through constant change,” Kragl said.
Engel’s Jeff Hershey discussed the values of single purpose cells, closed-loop toggle lubrication and encapsulating conveyors with high-efficiency-particulate-air filters to meet clean room requirements. Hershey is medical business unit manager for Engel North America.
Annually, Engel makes about 1,800 robots in its E-pic B sprue picker servo, E-pic Z linear robot pick-and-place, Viper linear robot and Easix articulated robot product lines in Austria and, in the Czech Republic, produces about 1,500 conveyor belts for use with injection molding machines or in free-standing formats.
For faster North American press deliveries to customers, Engel has embarked on what it calls a fast-lane program to pre-position compact all-electric E-mac machines of 55-190 tons and tie-barless Victory Hy-Spex presses of 55-340 tons, Hershey said.
As built, Engel equipment is compliant with Class 7 clean room requirements, Hershey said.
Michael Traxler said Engel’s Inject 4.0 solutions for the smart factory places the company in positions as a user-transforming machine production to order-and a provider-developing solutions for customers. Traxler is packaging business unit manager for Engel North America.
Engel’s E-factory package can help a user monitor, analyze, plan and maintain control.
“Energy recovery is viable for larger machines” with clamping forces of more than 331 tons, he said.
For energy efficiency, “just using electric is not good enough,” Traxler said. “You must put a strong focus on what is needed” for longer term sustainability.
Traxler noted that the focus of press sizes for most packaging applications is in the range of 176-551 tons.
Engel is highly integrated, but, for ball screw spindles, two unidentified Japanese suppliers make the product to a proprietary Engel design for use on injection molding machines for packaging applications.
The U.S. unit of plastic packaging maker Alpla Werke Alwin Lehner GmbH & Co. KG of Hard, Austria, is embarking on a development project to backstop its 14 domestic plants through a “mission control” concept in McDonough, Ga.
“We want to make sure the plant people have everything they need to do the work,” said Philipp Lehner, general manager for North America with the Alpla Inc. unit in Georgia.
Alpla began developing the concept in 2013 and, as of September 2016, started monitoring process-relevant data for the U.S. production sites with the intention of minimizing downtime and production outages. The U.S. locations employ about 1,200 and have annual sales of about $400 million.
Alpla product lines include packaging systems, bottles, caps and preforms. Production equipment includes injection molding, extrusion and stretch blow molding machines.
Jordan Robertson discussed the value of stack molds. He is general manager for business development and marketing at StackTech Systems Ltd. in Brampton, Ontario.
“Stack molds increase productivity up to 300 percent,” Robertson noted. “Flexible mold technology reduces changeover times by 90 percent.”
He said in-mold labeling technologies increase a package’s value, a trend “particularly embraced in the Americas.”
With stack mold designs, “you can have whatever you want,” Robertson said.
StackTeck manufactures multi-cavity, high-volume production molds suitable for thin-wall packaging, closure, personal care and medical product applications.
Jan Nietsch, a California-based business development manager for Elexis Group’s Hekuma GmbH of Eching, Germany, discussed the value of automation for manufacturers.
To illustrate his point, Nietsch ran a portion of the 1936 Charlie Chaplin film “Modern Times” showing humans fumbling and flailing on an assembly line.
Nietsch used examples of the Hekuma dual server robot and/or the expandable modular Hekuflex automation system to show how technology can help in manufacturing contact lenses, pipette tips and interdental brushes.
Beginning in December, Engel West in Corona invested about $150,000 to double the size of its training room, remodel the technical center’s entryway and install glass more doors for interior transparency.
The training space now occupies about 320 square feet of the 7,200-square-foot structure that Engel acquired and initially occupied in 2009, said Markus Lettau, west region director of sales for Engel North America.
Engel West’s direct sales staff includes Tony Avaloz, Eric Fuertes and Michael Valentino. Adams Engineers and Equipment Inc. of Tyler, Texas, represents Engel West in Texas and Oklahoma. Adams also represents other regions of Engel North America in Tennessee, Alabama, Arkansas, Louisiana and Mississippi.
Engel showed a variety of new technologies.
For production of a small PET container, Engel collaborated with mold maker Foboha of Haslach, Germany, and packaging specialist Alpla Werke. Integrated time-savings processes are based on cube technology. Four stages involve molding a preform, heating the material, injection blow molding the bottle and ejecting the product. Cycle time is 7.5 seconds on a 242-ton Engel E-motion press. Foboha reports within the molding solutions business unit of publicly traded Barnes Group Inc.’s industrial segment.
For a storage box with a living hinge, Engel applied its iQ software products for analyzing critical process parameters including vibration control. M.R. Mold & Engineering Co. of Brea, Calif., made the one-cavity prototype mold with assistance from Progressive Components of Wauconda, Ill.; Craftsman Tool & Mold Co. of Aurora, Ill.; and Mastip Technology Ltd. of Auckland, New Zealand. The mold ran on a 110-ton Engel E-mac with a fully integrated Engel Viper 12 robot.
Engel molded and packaged 500-bristle Scrub-brand interdental brushes in a follow-up to a similar demonstration of the technology from Pheneo GmbH of Bremen, Germany, at the K 2016 show in Düsseldorf, Germany. A specially developed compound of polypropylene and thermoplastic elastomer ran on a 120-ton Engel E-motion press in 4.5-second cycles. Mold maker Hack Formenbau GmbH of Kirchheim unter Teck, Germany, and automation specialist Hekuma collaborated with Engel.