MEDICAL & EQUIPMENT DEVICES u Sumitomo (SHI) Demag
Furthermore, the introduction of strict user parameters ensures that explicit medical component quality assurance and validation standards are consistently adhered to. The key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates. If these are altered in any way, it can trigger a costly re-validation exercise. By limiting the range on what an operator is authorised to adjust, validated micro medical injection moulding processes can be maintained.
8 standards and comply with any GMP and FDA regulations.
With the IntElect, 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 systems 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 IntElect units are now characterised by their unsurpassed freedom to accommodate a variety of tool configurations and are geared towards the mass-production of micro-medical components,
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 IntElect is able to fill up to as many as 96 micro cavities with precision, ensuring higher quality
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components are produced consistently. Energy efficiency and Total Cost of Ownership (TCO) are also greatly enhanced by the high- performance drives. Verified by extensive machine and part lifecycle durability tests, the clamp spindles were tested under the most extreme conditions and showed no evidence of visible wear – even after millions of cycles. Increasing the capacity of the IntElect’s energy
recovery system has not only improved energy efficiency but also extended the longevity of electrical components. Improved temperature control of the machine’s spindles, motors and inverters all help to guarantee safe operation of machine, even for the highest performing micro-moulding applications. As a result of the more consistent operating temperature, energy consumption is lower. An additional benefit is the reduction of heat that is required to be removed air-conditioned environments. Thus, helping to further lower operational costs and increase profit margins.
PREDICTING THE FUTURE In today’s globalised multi-site medical component production facilities, the ability to monitor and reconcile data from numerous machine sources is now imperative Having access to this data via a single gateway can assist production managers to better manage inefficiencies, reduce costs, improve total cost of ownership, troubleshoot and resolve equipment issues and minimise machine downtime. Advanced batch tracking, contact-free inspection using cameras, and highly automated assembly are among the latest developments to meet the market’s precision and quality control requirements.
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 Sumitomo (SHI) Demag R&D pipeline. Anatol Sattel, business development director
medical, says: “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.
Sumitomo (SHI) Demag
www.sumitomo-shi-demag.eu
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