Pooling its engineering competences and technological resources, BASF’s Performance Materials division in collaboration with Sumitomo (SHI) Demag and H + S Automatisierung have created a manufacturing cell to produce a range of test specimens for the product development and research activities of thermoplastic polymers and compounds.

At the MEDevice show in Boston on September 25-26, Accumold will showcase a variety of innovative medical parts and components at booth 815. These products reflect the company’s extensive experience and deep understanding of design for micro manufacturing (DfMM). Accumold stands out due to its vertical integration, enabling it to serve as a comprehensive partner in developing and manufacturing medical devices. Their offerings include design and material support, micro tool fabrication, proprietary micro molding services, advanced metrology, assembly, and automation. This integration streamlines the medical product development process, optimizing timeliness, innovation, cost, and accuracy.

Micro molding for medical device OEMs requires years of expertise and the right business culture, personnel, and equipment to ensure project success. Micro molders handle low, medium, and high volume runs with various materials, requiring different validation levels. They must also expertly manage the handling, storage, and processing of costly, sensitive materials used in critical implantable applications.

Accumold’s micro molding process enables the production of tiny, complex, and feature-rich components efficiently, cost-effectively, and in large volumes. The expert use of micro molding technologies provides medical device OEMs with a competitive edge, driving both product innovation and profitability. High-quality parts with precise dimensional accuracy are crucial for sensitive medical applications, including specialized devices for cancer treatment and diagnosis, small molded catheter tips, micro-needles, small surgical instruments, dental implants, infection control devices, and staples, among others.

Automation Systems Senior Engineer at Sumitomo (SHI) Demag, Markus Hausmann explains: “In order to lower the temperature to 80°C and depressurize the insert to guarantee that the SDR robot can remove the mold insert safely, our machine control has to talk and interact seamlessly with BASF’s MES.

Creating tomorrow’s polymer innovations starts with understanding the chemical and mechanical performance and processing conditions of materials. At BASF’s Injection Molding & Extrusion Pilot Plant in Ludwigshafen, Germany, the newest all-electric, fully-automated injection molding cell from Sumitomo (SHI) Demag is delivering pioneering and repeatable results for more than 4,000 tests a year.

At any time, up to 12 interchangeable inserts can be loaded to the side magazine and then swapped automatically into the injection molding machine. By integrating an HB-Therm temperature control system with Sumitomo (SHI) Demag’s machine control, automated mold insert changes can be completed safely and efficiently, even when running the process at high mold temperatures.

Brett Saddoris, Accumold’s Technical Marketing Manager says, “We are excited to be at MEDevice Boston, and we are proud to have collaborated with numerous leading medical device manufacturers globally, working strategically with each to ensure the most efficient product development process. The key to success lies in medical device OEMs viewing their micro molder not just as a job shop but as a partner from the earliest stages of the design-to-market process to avoid costly errors. Manufacturing micro medical plastic products necessitates a genuine partnership between OEMs and micro molding specialists, distinct from traditional OEM/supplier relationships. In micro manufacturing, the most critical issues often arise during the design and prototyping stages, including material selection and packaging considerations. A true partnership ensures faster time-to-market with more efficient and cost-effective products.”

The medical device industry demands increasingly smaller products with precise, micron-level tolerances, necessitating partnerships with micro molding experts like Accumold. These experts provide the precision, repeatability, and zero failure rates crucial for safety-critical applications.

Sumitomo (SHI) Demag’s IntElect 1000 kN injection molding machine is at the core of a fully digitized manufacturing cell producing test specimens for product development and research involving thermoplastic polymers and compounds.

Angelika Homes comments: “Unlike our former MES systems, this one logs every single aspect of a trial and the results, giving us insight for every single shot. This data is extremely valuable as it represents the entire processing sequence and enables us to draw deeper conclusions about how materials perform under certain conditions and how a customer might later process it.”

Then, the change of the mold inserts is synchronized to the cell control via output and input signals with transmission of the new mold data record via the robot interface. After the change of the mold insert, the temperature control units are heated up again. Automatic operation resumes and a new mold data record is initiated as soon as the target temperature is reached.

For operative safety and efficiency, a linear SDR 5-35S robot serves two purposes. A new feature is full automation of the selection and placement of 12 interchangeable mold inserts from a magazine located within the cell. After the part is molded, the same robot fitted with a multifunctional gripper gently extracts the test specimen from the mold and passes it to the small six-axis, articulated-arm Yaskawa GP8 robot for precise cutting of the specimens from the gate using a servo spindle drive punching machine.

Saddoris continues, “Medical device OEMs are under pressure to maintain profitability despite decreasing prices, which necessitates the development of innovative products that meet increasingly stringent end-user demands. There will be a growing need for versatile devices that leverage the potential of 'smart' diagnostics and treatment through the proliferation of 'big data,' as well as cost-effective alternatives to traditionally expensive diagnostic and therapeutic devices. Micro molding is the preferred solution for many medical device OEMs to meet these rigorous manufacturing requirements.”

Accumold invites all medical OEMs at MEDevice Boston to visit and discuss how micro molding with Accumold can drive the manufacture of innovative, timely, and cost-effective medical devices.

At the pilot center, the BASF research team typically configures 20 test settings daily on this machine. That means the control program of the cell has to be adapted to different materials, sample geometries, temperatures, and processing parameters. Every single setting that runs is recorded and documented digitally.

BASF’s MES informs the cell when the current produced sample setting is about to end, lining up the next mold application. Immediately after the injection process stops, cooling of the mold insert is directed by the integrated temperature control unit interface.

Taking center stage in the cell is Sumitomo (SHI) Demag’s ultra-precise IntElect 1000 kN injection molding machine. Selected for its compact design, energy efficiency, and repeatability, the IntElect’s enhanced welfare and safety features were also welcomed by the team of 30 research operatives at the facility. Progressive solutions to automate mold changes and low noise emissions combined with fully-digitized robotic processing solutions also received high marks.

Many of the specimens processed at BASF’s technical centre are high-temperature thermoplastics, fiber reinforced and often flame retardant. Consequently, melt temperatures can reach up to 400°C with mold temperatures hitting 180°C.

Integrating BASF’s existing mold insert concept and special features into the injection unit, the installation also includes a thermal temperature control unit and a new digital Manufacturing Execution System (MES) to map each test sequence. Reinhard Jakobi, Head of Performance Materials Processing at BASF, describes the project as an achievement of advanced engineering combining mature technology with state-of-the-art automation and molding precision.

For BASF, solving the punch challenge was one of the greatest engineering accomplishments. Due to its extensive application profile, BASF tests a wide range of materials from soft and tough to stiff and brittle polymers. There are also many different sample geometries, including thicknesses varying from 0.8 to 4 mm. All BASF test specimens are manufactured in accordance with the ISO 294 standard. This specifies the precision of the sprue system and specific requirements each sample geometry must fulfil. “Removal by punch is a pre-requisite, as it does not change the material properties and eliminates dust particles,” explains Hausmann.

The multifunctional gripper ensures all sample geometries are placed with exacting precision onto the punch plate. This is complex in itself because BASF works with many materials that have high fiber glass content, which can cause warpage. Describing how the servo driven parallel punch gripper overcomes the challenge of placing parts securely onto the punch plate, Hausmann notes: “If the test specimens are not held sufficiently well in place, the punchings could be crooked or not conform to specified quality standards.”