At K 2025, ENGEL will present the ENGEL validation assistant – a revolutionary qualification and validation strategy for the digital support of validation processes in medical technology. This tailor-made product package combines strategic solutions and digital assistance systems tailored to risk-based production processes.
It saves time and resources while significantly reducing process risks – in full regulatory compliance, scalable and practical. Developed in cooperation with innovative partner HACK Formenbau GmbH and Professor Thomas Seul, this integrated solution merges machine-side assistance functions, tool-integrated sensor technology and structured software modules into a flexible, open-technology toolbox for GMP-compliant injection moulding processes.
Efficient and compliant validation
The production of medical devices is subject to particularly strict regulatory requirements worldwide. All injection moulding cells must be qualified, and the manufacturing processes validated, with the validation of the injection moulding process in particular posing complex challenges. The validation assistant specifically addresses these requirements and supports all four phases of validation: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) through to successful Process Validation (PV).
The validation assistant’s strategy begins by taking into account the product-side User Requirements Specification (URS) and its Critical Quality Attributes (CQA). Based on these, the Critical Process Parameters (CPP) are identified and used to derive CPP-based qualification measures. This also forms the basis for combining the required digital modules, enabling shorter project lead times, lower resource usage and increased process reliability. The validation assistant is suitable for both small and large production lots.
A holistic digital strategy
The ENGEL validation assistant relies on precisely coordinated components: on the machine side, it integrates ENGEL’s digital assistance systems – including iQ clamp control, iQ hold control, iQ weight control, iQ flow control, and the iQ process observer. These systems support process window determination and automatically monitor and control critical process variables within a validated and thus approved production environment. Product release is still carried out with the usual reliability based on defined product-specific quality criteria. In addition, these systems help build process understanding and support in-depth process analyses.
At the K show, ENGEL is demonstrating the validation assistant on an e-motion 280 combi MW injection moulding machine – the core of a forward-looking production solution for highly complex 24-well cell culture plates and lids. The innovative high-performance Variotwinstack mould technology from Hack Formenbau significantly reduces the complexity of conventional stack moulds while also cutting maintenance and setup times.
Maximum process reliability and efficiency are ensured by the intelligent HACK® moldlife® sense sensor system, which continuously monitors key parameters such as mould alignment, breathing, temperature profile and acoustics in real time. Mould data is aggregated with machine sensor data via the EUROMAP 82.5 interface directly on the ENGEL control unit.
The system is complemented by an interactive maintenance management module that ensures maximum productivity and consistent part quality. Furthermore, the ENGEL validation assistant provides structured documentation elements such as checklists for virtual design-of-experiments (DoEs), which are verified using a reduced number of real-world DoEs, along with digital machine documentation.
From Design to Requalification
Whether initial validation or requalification – the ENGEL validation assistant supports the entire process. Already during the concept phase, virtual DoEs can be used to simulate process behaviour and pre-evaluate the designed machine-mould combination for design qualification. This not only saves time and cost during qualification (e.g. during milestones such as FTD, FIR, FOT, FAT, SAT), but also reduces both process and product risks, as well as effort during trial execution on the production cell. Beyond the initial validation, the assistant also supports further measures for re-qualification and revalidation. Based on a machine-independent process capture, the validation assistant even enables validated process windows to be transferred to other ENGEL machines.
Parametric Release ready
A key objective of the ENGEL validation assistant is to support future release strategies such as parametric release. In this approach, product release is no longer based on testing each individual end product, but instead relies on valid monitoring of critical process parameters (CPP).
Compliance by design
The modules of the ENGEL validation assistant are designed to meet the requirements of applicable regulations, including ISO, FDA, EU-GMP, and country-specific standards. This applies to sensor calibration, the commissioning of digital assistance systems, as well as their application and the documentation of results.