Darren Herron, UK national sales manager at Sumitomo Demag, analyses the injection moulding market and what is driving new developments for medical applications.

Engel said it is increasingly receiving requests for custom solutions in the extremely high clamping force range. Clamping forces of 10,000 tons and more are possible. Machines of this size can process individual shot weights of several hundred kilograms or pounds and achieve two-ton-per-hour material throughput.

Two injection molding machines with a clamping force of 8,000 tons each have now been delivered by Austrian injection molding machine maker Engel to the Infiltrator Water Technologies (IWT) plant in Winchester, KY. IWT took delivery of the first Engel duo 130000/130000H/8200 combi US machine, the largest machine ever built at Engel’s St. Valentin facility in Austria, in February of last year. A second machine, a replica of the first, arrived at the facility this month. IWT, a subsidiary of Advanced Drainage Systems (ADS), produces water management products.

Sumitomo (SHI) Demag recently supplied a 75 tonne IntElect all-electric injection moulding machine to Avenue, a Nolato Company, in Sligo, Ireland. The investment supports the growth in the company’s healthcare division, providing dedicated capacity to mould precision parts during the product development phase. With demand for its medical device injection moulding and tool-building services increasing, Avenue recently installed a new 100 sqm ISO Class 8 cleanroom area.

This creates some complications in relation to the CE marking process on medical devices as the UKCA (UK Conformity Assessed) mark will replace the longstanding CE mark for goods, including medical devices, sold within England, Wales and Scotland. As there’s no hard border in Ireland, the CE mark still applies there.

Special shipping and ground transportation arrangements were needed to move the machine from Austria to the United States and even within Austria. The platens were transported to and from the St. Valentin manufacturing facility along the Danube River on barges. “Each machine was fully assembled and tested prior to shipping and then disassembled to be shipped to the United States,” said Jim Moran, business development manager at Engel North America.

Advanced batch tracking, contact-free inspection using cameras, and highly automated assembly are among the latest developments to meet the medical device market’s precision and quality control requirements. Traceability is not just about mandatory information and supply chain tracking. Real-time traceability is about being able to call up data and verify the exact settings used on the injection moulding machine when that individual plastic part was made, making connectivity to a Management Executive System (MES) vital.

To enhance patient safety, there’s a drive towards using new and more innovative regulated materials with a better flow and high impact strength to mould components. The EU Medical Device regulations came into force 26 May 2021, following a one-year extension due to the pandemic. In Vitro Diagnostic medical device regulations (known as IVDR) become effective 26 May 2022. In the UK, the market is currently regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Establishing an Irish office is also part of a post-Brexit insulation strategy that will moderate any potential concerns Irish moulders may have about dealing with a UK machinery supplier. A permanent in-country service and support base will facilitate timely spare parts sourcing and trading in euros without incurring hefty exchange fees. We firmly believe that Ireland’s talent base and this supportive infrastructure will continue to make Ireland very attractive to inward investment, especially in medical and biotechology R&D.

The IntElect machine met Avenue’s brief for a small footprint machine for carrying out test runs during the development phase of projects.

Plastic moulding continues to be used for many medical applications, including manufacturing implantable medical device components, test tubes, beakers, casings and housings for laboratory and medical equipment, drug delivery components and surgical equipment. With demand for medical devices at an all-time high across hospitals and laboratories thanks to COVID-19, this has had a positive impact on market growth.

The duo injection molding machines each have two 85,000 cm³ injection units, which allow for injecting a total shot weight of 270 lb (122 kg). Despite the clamping force and shot size, the machines have a relatively small footprint — 96 ft. (29.3 meters) long and 37 ft. (6.4 meters) wide — enabled by Engel’s two-platen design.

Getting the 8,000-ton machines from Austria to the Infiltrator Water Technologies plant in Kentucky was a logistical challenge.

The machine’s small footprint is down to the use of its own motors and drives. The model also has 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.

“We have made significant investments in new equipment, and this will allow us to produce our products more effectively and efficiently,” said Bryan Coppes, vice president of engineering and R&D at Infiltrator. “It is the new capabilities and opportunities for continued product development that are truly exciting. This new equipment will allow us to continue to bring new and innovative products to market and meet and exceed our customers' needs.”

At the IWT site in Winchester, new manufacturing facilities had to be built to house the large machines. As 29 truckloads of machine parts were arriving from Austria, the 59,000-square-foot building expansion went forward. A 150-ton overhead crane was installed to move molds in and out of the machine and was also used to help assemble the new press.

Engel was recently awarded a gold sustainability rating by EcoVadis, which relies on data from more than 90,000 evaluated companies and global supply chains to rank companies.

With a large proportion of Sumitomo (SHI) Demag’s Irish customers in the medical market in Ireland, we last year opened a service and support office in Limerick, Ireland. This was to support its installed base of predominantly all-electric machines, providing on-the-ground preventative and reactive machine maintenance and troubleshooting support.

Gerard Henn, Avenue’s general manager, said: “All medical programmes are lengthy as it can take two to three 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.”

The global medical injection moulding market size was valued at $1.38 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% between 2020 and 2027. Much of this is being driven by advances in the home healthcare sector and an ageing population, which WHO predicts will double by 2050.

Engel said it received the purchase order in November 2020 and completed handover of the first machine in February 2022. The second machine, a replica of the first, was delivered this month.

Engel added in the news release that it shares a commitment to sustainability with ADS, which claims to recycle more plastic than any other company in North America.

For example, when parts are being produced on multi-cavity tools, like pipettes, robots are programmed to remove and place the components into cavity-assigned racks. This means that if an issue with cavity 1 arises, the rack containing all corresponding cavity 1 parts can be isolated and the rack recalled, with all the production information stored in the MES.