York, Pa. — Processors serving the medical market should stay on top of rules and comments from regulatory bodies like the Food and Drug Administration, and standards groups such as ISO — and not simply rely on customers for that knowledge, a Saint-Gobain official said at the Engel Technology Symposium.
"The regulatory environment impacts everybody down the supply chain," said Robert Schwenker, business manager of medical components with the fluid systems business of Saint-Gobain Performance Plastics Corp. in Austin, Texas.
Technology dominated much of the event at injection molding press maker Engel Machinery Inc. in York, held April 26-27. Speakers talked molding, automation and molds, as they addressed medical the first day and packaging the second day.
Schwenker's topic was regulatory affairs.
"By reading what the FDA is putting out there, you can start to get ahead of what's going to be important in the next few years," he said.
Medical is a demanding market, but Schwenker said it's an uplifting business. At the end of the process, there's a patient who gets help.
Medical device manufacturers are looking to harness the expertise of plastics suppliers, but at the same time, the original equipment suppliers want the processors to assume more liability, Schwenker said.
"A lot of it is managing risk," he said.
Pay attention to what regulators say. Pay attention to what they do.
Schwenker encouraged plastics processors to keep up to date.
"How much risk is in the value chain and how much am I responsible for?" he said, adding that assessing risk up front is important.
The medical market demands thorough record keeping, and a "growing amount of paperwork," Schwenker said. Saint-Gobain has validation programs for new injection molding machines and facilities, and defined programs for new production introduction. The increased rules are important, but they can extend lead times, he said. That's why it's important to look ahead to likely future regulations, he added.
"The idea that you put your head in the sand and say, I'm just an injection molder, isn't going to cut it," Schwenker said.
Engel ran five injection molding cells at the Technology Symposium, showing a "smart" e-motion machine with a clamping force of 85 tons running the company's iQ software offerings that continuously adjust the press, a 110-ton e-motion press molding a new dental-care brush, liquid silicone molding of a technical "duck bill" part on a 120-ton Victory Hy-Tech, an electronic part on an 85-ton Victory Hy-Spex press and a new injection blow molding system that turned out small bottles using a rotating cube.
Jan Nietsch, U.S.-based business development manager for robot maker Hekuma Group, said high-speed takeout robots can remove parts faster than in free-fall out of the mold, and orient them properly for vision-system inspection, cavity separation, downstream packaging and assembly and packaging. Medical accounts for half of Hekuma's business, he said.
Automation boosts quality and lower labor costs, which Nietsch said are climbing around the world.
"Humans are great robots, but they're dirty and they make a lot of mistakes," he deadpanned, as the audience at the symposium chuckled.
Engel Holding GmbH in Schwertberg, Austria, also makes 1,800 robots a year, said Stefan Aberl, Engel automation manager for North America. The company employs 450 in automation worldwide, a dozen of them in York.
For medical clean room molding, Aberl said, Engel can provide fully enclosed end-of-arm tooling and conveyor systems.
