Medhealth insight

Enhancing Medical Injection Moulding for Increased Intelligence & Simplicity

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In the past decade, the practice of quality assurance during production has become a standard across industries, offering insights into both process and product quality. Simultaneously, advancements in digitalization and process automation have significantly evolved. This article sheds light on the state of process monitoring and control amidst current trends like AI and regulatory updates.

Back in 2010, there was considerable scepticism regarding cavity pressure measurement. Those embracing the technology primarily focused on basic process monitoring, overlooking more sophisticated prospects. At Kistler, a pivotal project was the development of ComoNeo, a significant upgrade from ComoInjection. Tailored for injection moulding, ComoNeo offered a superior user interface, swiftly gaining traction, particularly in the medical domain. To address the needs of medtech firms, an internal group merging expertise in plastics applications and advanced manufacturing were formed. This collaboration highlighted the potential of data analysis in the medical sector, becoming the exclusive provider of the Stasa QC process navigator. This system facilitates efficient documentation and process analyses.

Quality management is paramount in the medical realm due to the production of highly sensitive goods. Regulations like Good Manufacturing Practice (GMP) in the US and Medical Device Regulations (MDR) in Europe mandate strict compliance with extensive standards. The emphasis on meticulous documentation places significant pressure on companies, necessitating integrated process solutions. For instance, the ComoNeo system precisely measures cavity pressure and employs AI through ComoNeoPREDICT to forecast product quality. There’s untapped potential for digital solutions in this domain.

Currently, software modules and algorithms enable injection moulders to automatically adjust parameters based on measurement curves. The Multiflow module optimizes cavity filling by analyzing pressure differences and adjusting hot runner temperatures accordingly. Automation is crucial, especially amidst a shortage of skilled labour. While the circular economy and recyclate use are prevalent in other sectors, their adoption in the medical field awaits regulatory alignment. Nonetheless, as recyclate usage grows, continuous monitoring becomes vital, with AI poised to detect and predict anomalies effectively.

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