Once the preserve of pharmaceutical and medical device injection moulding, cleanroom production facilities are now cropping up in the automotive, micro-electronics and bio-technology sectors too. Yet, cumbersome planning and smaller factory footprints means many moulders seeking to eliminate contamination from plastic parts are shifting their thinking from large, fixed cleanrooms and seeking more compact, mobile systems, observes Nigel Flowers, Managing Director at Sumitomo (SHI) Demag UK

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MGS Mfg. Group Inc., a global supplier of end-to-end manufacturing services to the healthcare industry, has acquired Danish tooling manufacturer Winther Mould Technology A/S. The investment in additional tooling capacity and expertise continues its strategic growth as a leading provider of high-precision plastic solutions for pharmaceutical, diagnostic, and medtech applications, said MGS in the announcement dated Oct. 2, 2023.

“Over and above its primary purpose, the six-axis robot offers secondary operations including assembly and palletising - giving added value for manufacturers seeking expansion options and faster pay back,” adds Nigel. The final element of the turnkey system is an AVT fully integrated packing system, which bags multiple products in the controlled conditions before they exit the machine.

“We celebrate this new growth milestone for MGS, which further strengthens our offer of unparalleled tooling capacity to ensure the seamless launch of large-scale programs. Our expanding global footprint continues to provide healthcare innovators with end-to-end support for new product introductions and ongoing production,” said Paul Manley, president and CEO of MGS. “MGS and Winther Mould share a strong customer focus and commitment to agility and reliability. Together, we are poised to deliver unmatched value, precision, and dedication to our global customers to accelerate the development of innovations that improve lives,” said Manley.

He continues: “A self-contained unit like this offers a lower-investment entry into cleanroom manufacturing in what may otherwise be cost prohibitive. What’s more, it can actually maintain a higher output, as people don’t need to enter or leave the cleanroom, resulting in continuous, uninterrupted production.”

The company’s activeCell system - a self-contained injection moulding cleanroom - achieves ISO Class 7 manufacturing performance, yet only requires approximately 13 square metres of floor space for the 160 version. “The space occupied by a fixed injection moulding cleanroom with air filtration system could measure anything from 32 to 50 square metres,” notes Nigel. “What’s more, they can be expensive to build and costly to operate and maintain.”

As a solution, Sumitomo (SHI) Demag engineered a fully configured injection moulding machine, which in itself is a full clean room cell, enclosing all the exposed points where a plastic component may come into contact with the environment. Designed to manufacture single or multi-components, activeCell is readily certified to ISO Class 7 (10,0000) requirements to comply with GAMP and FDA standards as well as DQ, IQ and OQ documentation.

Available in 100, 160, 220 and 280 tonne formats, the compact fully guarded cell is only 500mm wider than a standard machine. Yet it incorporates all the required ancillaries. The cell features laminar air flow systems sourced from Max Petek. These flood the mould surface and part handling areas with HEPA filtered air. Once parts are moulded, a Motoman six-axis robot quickly and accurately transfers product to the conveyor system, chute or packaging system as required.

Operating as a system integrator, Sumitomo (SHI) Demag oversees the entire project and installation, in addition to providing rapid response, post-sales service, customer support and spares from a single source. “The machine is built to specification and tested off site, with final certification completed on site as the results are unique to each manufacturing environment. This means a clean room system can be installed and certified in several days rather than weeks,” ends Nigel.

It’s the second acquisition of a Danish company by MGS this year. In June, it brought Technolution under its wing, a consultancy that provides R&D, regulatory compliance, quality, and project management assistance to companies in the pharma and medtech sectors.

“activeCell not only takes up less production space, it challenges the traditional approach to cleanroom production,” says Nigel.

It unites all the technology in one unit and by automating the entire process from moulding to packing, it helps to eliminate human contamination risks.”

To achieve a clean production environment, the main focus must be on the end product, i.e. the formed parts must be protected from contamination, Nigel explains. “In practice, this means that the path of the formed parts out of the mould for packaging or further processing is critically reviewed. The moulder should have a clean-room zone which, with a minimum of expenditure for technical equipment, offers maximum protection from contamination in relation to the application.”

The all-electric compact turnkey system is equipped with a platen mounted six-axis robot, laminar airflow cabinets for particle free air in the mould-space area and integral packaging equipment. Nigel puts this into context: “In effect, it means the parts produced never have to leave the cleanroom environment until they have been packed.”

Winther Mould brings 56 years of experience in design for manufacturing (DFM), mold design and manufacturing, and testing and validation to the MGS portfolio. In partnering with Winther Mould, MGS said it will add complex, premium-quality tooling and moldmaking capacity and expertise to its international network of tooling, automation, and manufacturing capabilities. MGS currently operates from 12 locations in the United States, Mexico, Ireland, Sweden, Germany and Denmark.