If you’re looking for a production cell to mold some sharp-looking medical devices, head to stand D 22 in hall 15 at K 2019, where Sumitomo (SHI) Demag (Schwaig, Germany) is showcasing its new IntElect S electric press anchoring a turnkey medical molding cell. Designed to produce narrow-tolerance products in high volumes, the 180-tonne machine is molding pipette tips in a 64-cavity mold from Plastisud that contains a new two-injection point concept, explained Sumitomo Product Manager Anatol Sattel in a prepared statement.
The new mold concept in combination with Sumitomo (SHI) Demag’s machine technology deliver greater precision and repeatability, according to Sattel. “The ability to install small screws matched with a large mold space is a big advantage, as it improves dosing and injection performance, which is so critical when molding micro components like pipette tips,” he said. Moreover, direct-drive technology in the IntElect machines enables accelerated injection speeds to precisely fill 64 cavities, added Sumitomo.
The press also has been designed to satisfy the ISO 13485 quality systems standard for medical manufacturing. Sumitomo added machine parameters to prevent operators from making adjustments that are outside of specified ranges unless they have been authorized to do so. “Key areas that might impact a stable process include changes in pressure, temperature, flow rate and cooling rates, any of which may trigger a costly re-validation exercise,” explained Product Manager Peter Gladigau.
Materials supplier Borealis has provided its Bormed BJ868MO polypropylene co-polymer to mold the pipette tips on the K show floor. The material has a melt flow rate of 70g/10 min, facilitating filling of the 64-cavity mold, said Sumitomo (SHI) Demag. The co-polymer is engineered to support customer compliance with the European Union's Medical Device Regulation and IVD Regulation.
The production cell also is equipped with a Hekuma side-entry robot that provides batch-level tracking and contact-free visual inspection.
The HEKUtip gripper system removes the 64 pipettes from the mold in less than 0.6 seconds and places them in corresponding racks. If an issue arises with a specific cavity, the rack containing all corresponding parts is isolated and recalled.
After each rack is filled, a camera visually inspects the components from multiple angles to ensure there are no holes or burrs. For optimal quality assurance, the tip is inspected from the bottom of the pipette, as well as from a side angle. The tip collar is inspected from above.
HEKUtip’s modular design can accommodate up to 128 cavities; 100% camera inspection or random quality checks are available as options. Product rack labelling also is available, as well as further automated packaging configurations, including stacking, lidding, banding and shrink wrapping. Systems also can be configured to include filter separation, feeding and filter assembly, and batch tracking.