Features of Medical micro-Moulding Trends

Meeting GMP requirements Any airborne contaminants, such as dust and particles from the raw materials, as well as human contaminants like bacteria, could affect the function of a medical component. Although cleanrooms aren’t a requirement for all micro-moulded parts, medical components should be manufactured and packed in a self-contained cleanroom environment to meet ISO Class 7 or 8 standards and comply with any GMP and FDA regulations. With the machine, accompanying validation DQ, IQ and OQ documentation is automatically issued on installation. A large number of medical machines will have a complex automated end of arm tooling system to ensure parts are removed without damaging them. Often, vacuum extraction systems are integrated within the automation cell to remove micro medical device parts from the IM machine. Given that many can be smaller than a match head, a vacuum helps to prevent parts getting lost within the machine or falling to the floor. Additionally, these robotics prevent operators getting into direct contact with them, which could cause contamination. Ionisation within the cell is another important consideration. “This is not just to keep the parts clean, but also to keep the static out to ensure parts don't stick together. This makes the process easier for robots to handle and pack the components,” notes Sam. Flexibility and design freedom The smaller tonnage Medical units are now characterised by their unsurpassed freedom to accommodate a variety of tool configurations. Geared towards the mass-production of micro-medical components, Sam affirms: “The ability to install smaller 14mm screws with a large tie bar distance and mould space is a huge advantage for micro moulders. This level of control is made possible by our own highly dynamic direct drive technology and advanced toggle system. With acceleration of the injection speeds, the machine is able to fill up to as many as 96 micro cavities with precision, ensuring higher quality components are produced consistently.” Predicting the future During the last 24 months, machine features such as remote diagnostics have been well adopted by customers as they strive to maintain operational efficiency and save money, while adhering to health and safety guidance and ensuring machine assets are safeguarded. Matching market advances, exciting new processing features and digitalisation projects are already filtering through the R&D pipeline. Outlining several of the new features on the immediate horizon, Anatol Sattel, business development director explains: “We are currently developing an IoT dashboard. Our ultimate vision is an intelligent machine that can independently make predictions about part quality, machine wear and failures and perform optimisations online.” Rapid development of various micro surgical, nanotechnology, micro-optics and microfluidics will inevitably increase demand for microinjection polymer moulding throughout Europe. As moulding companies continue to size up the opportunities, Sumitomo (SHI) Demag will continue to adapt its machinery line up to flex to growing demands.