Sumitomo (SHI) Demag announces fully automated in mould decorating production cell
Sumitomo (SHI) Demag, a moulding machine specialist has pioneered a fully automated In Mould Decorating (IMD) production cell. This cell can be used to issue medical devices with Unique Device Identifications (UDIs) ahead of the enforcement of the EU Medical Device Regulations (MDR).
On May 26th 2020, the new EU Medical Device Regulations (MDR) which mean that every device or its packaging must be issued with a UDI will be enforced. The IMD production cell hopes to tackle what some in the industry perceive will be a challenging and costly undertaking.
Designed predominantly for healthcare, automotive and aerospace manufacturing environments where quality control and traceability are critical, the advance hopes to represent a colossal change in how multiple components are individually issued with a unique identifier.
This means that any potential quality defect, which might not be picked up for several months, or even years, can be tracked back to the very day and cycle it was manufactured to achieve item-level traceability and conduct root cause analyses on parts and components.
Nigel Flowers, managing director at Sumitomo (SHI) Demag UK emphasises that authentication of individual components in high liability markets like healthcare requires a fingerprint style approach to traceability.
Additionally, labels in the future will need to include two identifiers: A Device Identifier (DI) that identifies the labeller and the specific version or model of a device, plus a production identifier. This variable portion of the UDI needs to include the given lot or batch number, serial number, date of manufacture, expiry date, etc.
Flowers explains, “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. That’s where connectivity to a Management Executive System (MES) is vital.”
This represents another step towards the smart factory for tier 1 to 4 medical device injection moulders, offering heightened risk management, mitigation and containment, which enables organisations to respond accurately and rapidly with a targeted recall.
To eliminate the risk of the wrong QR code being applied to the medical device component, Sumitomo (SHI) Demag deploys a highly dexterous 6-axis robot to remove each part from the mould. The robot holds the part during the entire time the QR code is etched on at the laser marking station, never releasing until the data has been scanned and stored in the holding data system.
“What we have created is a fully automated plastic injection moulding and laser marking station that connects and communicates the code back to MES holding system where it reconciles up with the machine processing data. In addition to boosting traceability, this synchronised data gives production managers greater visibility on product cycle times and quality,” adds Flowers.
Process data that’s recorded includes the exact production date and time, the injection and dosing time, melt cushion, injection pressure and temperature.
This enhanced traceability aims to enable organisations to respond more effectively should a defective medical device part or component enter the value chain. Flowers comments, “it’s becoming increasingly imperative to limit operational risk exposures with targeted rather than mass recalls. Real-time traceability provides the means to limit recall exposure by improving end-to-end process transparency.”