TECHNOLOGY | MEDICAL PHOTO: ENGEL
According to Engel, in medical moulding Industry 4.0 solutions are gaining in importance, through intelligent assistance systems in particular. The top guiding principle in the medical technology industry has always been to have everything under control at all times, and to be able to prove what quality levels were delivered when and to whom. New solutions that make production more plannable, safer and more stable are also attracting keen interest. The challenge lies in integrating them within the guidelines of GMP, EN-ISO and FDA. Engel adds that it has found a solution to integrate even dynamic process control into the validation process. The iQ weight control assistance system is
Above: Produced in a two-compo- nent process, the housing parts for medical devices require a shorter cycle time
real-time control software that adjusts process parameters during the running cycle to ensure consistently high component quality. The software compares the injection pressure above the screw position with a reference pressure curve and identi- fies deviations in injection volume and viscosity. The automatic adjustment of the switchover point, injection profile and holding pressure compen- sates for target deviations shot by shot. Conse- quently, the switchover point and holding pressure level must be defined as critical process param- eters in the validation strategy. The validation strategy makes it possible to use intelligent assistance systems in medical technol- ogy, in order to further increase process consist- ency and process reliability. This allows quality fluctuations of the raw material and changes in ambient conditions to be dynamically and reliably compensated for in the validated process. Using simple logic, the innovative algorithms employed by intelligent assis- tance systems can be integrated into the validation strategy. Reducing cycle times and compact manufac-
turing cells are also currently highly relevant in medical moulding, adds Engel. With the aim of further reducing cycle time, the process of produc- ing housing parts for medical devices is split using two-component injection moulding. The process is cut down to a very short cycle time under realistic production conditions. “The key thing with housing parts is the cooling
time,” says Georg Steinbichler, Senior Vice-Presi- dent of research and development for technolo- gies at Engel Austria. “Since the wall thickness
60 INJECTION WORLD | September 2019
Above: A cleanroom version of an all-electric E-motion 310H/170W/160 combi injection moulding machine is used to produce housing parts
cannot be decreased for stability reasons, conven- tional one-component production leaves no opportunity to reduce the cycle time. But in the two-component process, we inject two thin layers, each of which quickly cools. Since both injection moulding steps are carried out at the same time, overall production efficiency increases.” At K2019 Engel will demonstrate a Hack
Formenbau 8-cavity Vario Spinstack mould on the cleanroom version of an all-electric E-motion 310H/170W/160 combi injection moulding machine. This is equipped with a vertical indexing shaft with four positions: the first for injection moulding the bodies, using a transparent polypro- pylene from Borealis; the second for cooling; the third for applying a second layer of polypropylene (this time coloured green) to the pre-moulded parts; and the fourth for a viper 20 speed robot to step in and remove the parts. The linear robot reaches down to remove the eight housing parts from the closed mould, another factor contributing to the extra-short cycle time. Another advantage of the two-component process is that a sight glass can be added to the opaque housing just as it is being injection moulded. The two-component precision mould is fully servoelectric in its operation and is the first to use a newly developed software programme. This ensures that the servoelectric movements – core- pull movements, for instance – can be controlled in the same way as those of hydraulic systems. “With the software’s help, it makes no difference to machine operators whether the mould is hydrauli- cally or servo-electrically operated,” says Gerhard Dimmler, Senior Vice-President of product research and development at Engel Austria. “The user themselves can programme the servo-electric movements without the need for additional qualifications. As a result, we’re paving the way for
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PHOTO: ENGEL
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