Process-optimized injection molding of medical devices: quality assurance at every level – with ComoNeo

Winterthur, August 2021 – Injection molding is a widely used production process – but it presents a particular challenge for medtech device manufacturers: how to combine efficiency with process reliability? No easy task, especially as regulation in this sector is becoming stricter all the time. Kistler has the answer: its ComoNeo process monitoring system provides comprehensive quality assurance and maximum transparency, directly on the machine.

Producers and manufacturing companies in today’s medtech and pharma industries are faced with a multitude of requirements and regulations – with a constant flow of additional provisions such as the recently introduced amendment to the Medical Device Regulation (MDR) in the European Union. The MDR is intended to safeguard patient wellbeing, but it also obligates manufacturers to provide documented proof – presenting them with challenges that should not be underestimated.

The injection molding process is frequently used in the medtech sector to manufacture components and products such as inhalers, pen systems and syringes. Kistler offers ComoNeo to manufacturers as a holistic solution that will increase their product quality and process reliability. Based on the measurement of cavity pressure and temperature, this process monitoring system includes functionalities that ensure optimal efficiency combined with maximum transparency.

Efficient and transparent qualification and validation

During the qualification and validation phases, users can count on reliable support from the ComoNeoPREDICT feature in conjunction with the Stasa QC software to optimize operating points. As well as making data exchange easy, an integrated interface to implement test plans (DoE, Design of Experiments) provides automatic recording of the relevant process variables during process analysis and development. 

Stasa QC automatically determines the relationship between setting values and quality characteristics by systematically evaluating the generated process variables and the related quality data. The result: a dependable, transparent process window with the relevant part attributes.

High process reliability and complete traceability

ComoNeo also offers dedicated software functions to ensure the high level of process reliability that is essential in the medtech industry: monitoring and recording of the live process based on cavity pressure plays a key part here. With the help of ComoNeoMERGE, manufacturers can avoid short shorts so as to achieve zero-defect production – even for more complex multi-component applications. 

Continuous recording of the process data captured for each single product guarantees end-to-end traceability and transparency. Thanks to these features, manufacturers can efficiently meet their obligations to furnish proof, and they are always able to provide information to third parties. ComoNeo also offers additional functionalities to ensure compliance with the requirements for electronically generated data:

• ComoNeoLOG: automated management of guidelines and users (user management)
• ComoNeoLDAP: computer-generated, time-stamped electronic recording of all user activities (audit trail)

As regards connectivity too, ComoNeo offers everything that users could want: secure data exchange with third-party systems via OPC UA – exactly what’s needed for Industry 4.0. Kistler’s innovative process monitoring system for quality-assured injection molding also makes it easy to network user interfaces, with integration of the display settings in both directions – a central element of a well thought-out encapsulation concept to meet cleanroom requirements. 

Comprehensive service – from product idea through to series manufacture

Kistler firmly believes that any solution is only as good as the services that go with it. And to prove the point, process monitoring based on cavity pressure with ComoNeo is backed by a whole series of services:

• Support with sensor positioning and installation, and determination of appropriate quality criteria (risk analysis)
• Preliminary tests and process optimization on site at customers’ premises
• Support throughout various qualification phases, including the relevant checklists and documentation
• Application training on sensors and process monitoring systems
• Advice on data analysis and data models