
Nepal suspends sale of injection made by Indian company citing ‘serious
Author:gly Date: 2024-09-30
“Our business was already experiencing strong natural growth, yet the COVID crisis has augmented this growth — test products and IV fitments are in demand across the world,” says Henn.
He continues: “The footprint of the IntElect is nice and compact — not overly long or wide; it comes with a number of process control features and has all the interfaces needed to seamlessly connect with other pieces of supporting equipment.”
Certified to ISO 13485, Denmark-based SPT Vilecon describes itself as a fully integrated provider of development and manufacturing services to the medical device industry. It offers in-house tool making and injection molding along with other manufacturing services to companies in northern Europe.
Avenue elected several add-on options — activeFlowBalance, activeRemote activeLock and a VNC connection — to enhance control over the moulding process and guarantee the dimensional precision that is demanded by the healthcare industry. activeFlowBalance uses machine-control technology to balance filling fluctuations, ensuring shot-to-shot consistency, and activeRemote in conjunction with the VNC (Virtual Network Cable) allows remote diagnosis from Sumitomo personnel for both technical and process issues on-line.
SPT Vilecon said it has begun expanding the range of injection mold prototyping with silicone, metal, and ceramic materials to provide medical device manufacturers with an even wider selection of product development and verification services.
Design input collected from the first tests was integrated in a second iteration that took only a couple of hours to complete. By contrast, conventional metal tooling would have taken more than six weeks to design and procure, and the adjustments needed for the second iteration would have taken an in-house tool-shop a week to complete.
“The medical industry demands that components are produced within extremely tight tolerances and the allowable tolerances are getting tighter all the time. We find that these process control features are invaluable in ensuring customer acceptance of tools, instilling confidence that that they will work as intended to produce a precision component with high repeatability and accuracy,” says Henn.
Based on input collected from the first two iterations, the design of the silicone part was approved and manufacturing of a metal tool was initiated with full confidence of part moldability and performance. The in-house tool shop built the final metal tooling in four weeks without iterations.
“Usually, if you want to use a larger mould, you have to go to a larger machine, say a 100-tonne one. With the IntElect 75 you can run a larger mould in a smaller machine,” explains Darren Herron, Sumitomo’s National Sales Manager for the UK and Ireland.
This model has particularly wide tie bar spacing and high clamp force for its size, allowing the use of larger moulds than would normally be accommodated by a 75 tonne machine.
The machine’s exceptionally small footprint is down to the use of Sumitomo’s own motors and drives — some competitors buy these parts in, making a compact design more difficult to achieve.
Sumitomo’s 75 tonne IntElect all-electric injection moulding machine ticked all the boxes in Avenue’s brief for a small footprint machine for performing test runs during the development phase of projects.
“A lot of our medical device projects start with a development phase, when we need to produce a single- or two-cavity tool before scaling up,” explains Gerard Henn, general manager of the Ireland-based Avenue operation, which is an integral part of Nolato GW & the Nolato Medical Solutions business area.
A supplier of development and manufacturing services to medical device OEMs used Freeform Injection Molding from Nexa3D to accelerate time-to-market and slash prototyping costs for a complex silicone-based IV device. SPT Vilecon explained the process in a recent press release.
Medical device manufacturers are tasked with developing elaborate test protocols to ensure that the product in development is safe and meets essential requirements. If these tests are conducted late in the development process, the more onerous and risky they become. SPT Vilecon often works with silicone, a material that is extensively used in medical applications because of its chemical resistance, mechanical performance, and biocompatibility. However, silicone parts are notoriously difficult to prototype and test, since most grades need to be injection molded to achieve their full performance potential, said the company. FIM enabled SPT Vilecon to offer an alternative to a customer developing an intravenous (IV) silicone product — the use of 3D-printed tooling to perform early design and material verification at a fraction of the cost of conventional methods.
The 3D-printed molds for the first and second iterations cost less than €2,000 combined. And the technology enabled a two-day design cycle, which is more than 90% faster than conventional metal tooling.
The patented FIM process uses high-speed Nexa3D printers and xMOLD resin to print injection molding tools that are compatible with thousands of off-the-shelf injection molding materials, including reinforced high-performance feedstocks. The process reduces design, iteration, and validation cycles using end-product materials to a matter of hours rather than weeks.
Freeform Injection Molding technology from Nexa3D compresses design, iteration, and validation cycle times into a matter of hours rather than weeks.
Avenue has, in recent years, decided that any new presses should be all-electric on the grounds of the energy-efficiency, consistency and low noise advantages they offer compared with their hydraulic counterparts.
SPT implemented Nexa3D’s Freeform Injection Molding (FIM) technology to help customers shorten time-to-market on complex medical devices in demanding medical-grade materials and to expand on the range of materials that can be quickly and reliably used in prototyping and early device test manufacturing.
Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.
With demand for its medical device injection moulding and tool-building services on the rise, in summer 2019, Avenue installed a new 100 sqm ISO Class 8 cleanroom area at its Sligo facility. This expansion necessitated an increase in capacity for moulding tools for producing components such as vials, test trays, luer lock fitments & connectors, as well as shell housing mouldings & mating components, for medical device assemblies.
Avenue, a Nolato Company, has taken delivery of a 75 tonne IntElect all-electric injection moulding machine at its site in Sligo, Ireland, describing it as “the ideal machine for medical start-up projects”. The investment will support growth in the company’s healthcare division, providing dedicated capacity to mould precision parts during the product development phase.
Injection-molded silicone parts were produced within two days, allowing early verification of key design and performance aspects.
Avenue, a Nolato Company, has taken delivery of a 75 tonne IntElect all-electric injection moulding machine at its site in Sligo, describing it as the ideal machine for medical start-up projects.
The IntElect also comes with a choice of five screw diameters for maximum flexibility - Avenue can run a variety of tools with different shot weights.
The medical industry demands that components are produced within extremely tight tolerances The process control features on the IntElect are invaluable in ensuring customer acceptance of tools, producing precision components with high repeatability and accuracy.
Robust and valid prototyping and verification are key to minimizing cost, time, and risk factors in developing medical devices, said SPI Vilecon. FIM is a new toolbox for medical device companies seeking to accelerate their innovation and obtain early verification of part performance and moldability, added the company.
“All medical programmes are lengthy as it can take 2–3 years to obtain approvals from the authorities, so there are many months of testing before a component or mould is ready to be scaled up to mass production. Test runs might be anything from 10,000 to 100,000 units. “To satisfy this range of volume requirements, the mould size and cavitation suits this press perfectly,” explains Henn.
At the start of 2020, Avenue instigated discussions with Sumitomo, with a view to the new press coming on-stream by June/July.
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