Building the communication backbone between production systems, data platforms, and decision-support applications.
In pharmaceutical manufacturing, batch release is a critical quality step that determines whether a produced batch can be approved for distribution. After completion of a production process, a qualified decision-maker must assess whether the batch meets all predefined requirements.
During production, large volumes of process data are generated, including process parameters, equipment data, and relevant operator input. When all predefined criteria are met, a batch may be eligible for automatic release. However, when deviations occur, additional analysis is required to determine their impact. Based on this assessment, the batch can either be approved, subjected to additional testing, or rejected.
Customer
Our customer is a leading pharmaceutical manufacturer operating highly automated production lines where process stability, product quality, and operational reliability are critical.
Challenge
The challenge lies in creating a seamless connection between production instructions, operational data, and the digital platforms supporting batch release decisions.
Expertise
We provided the integration backbone required to ensure a reliable flow of information between production systems and decision-support applications.
The solution: Communication framework between production and digital platforms.
We developed a dedicated communication framework to enable structured and reliable data exchange between manufacturing equipment, operator interfaces, and higher-level digital systems. This creates the foundation for connecting production operations with advanced analytics and decision-support tools.
Connecting the production floor with data-driven decision-making
The result is a scalable integration layer that bridges the gap between shop floor systems and digital decision-support environments. It enables pharmaceutical manufacturers to leverage production data more effectively while maintaining a controlled and reliable batch release workflow.
Digital transfer of production instructions to equipment
Production instructions, including recipes, process parameters, and predefined criteria, are transferred from digital systems to the production environment in a controlled and standardized way. This ensures that manufacturing equipment receives the correct information required to execute the process.
Reliable transfer of batch data
During production, relevant batch information is captured and transferred to the systems used by decision-makers during the release process. This includes process data and operational information required for analysis, evaluation, and informed batch release decisions.
Enabling AI-supported batch release workflows
By providing a reliable data exchange layer, the framework enables the use of advanced data platforms and AI models developed by our partner. These technologies can support decision-makers by analyzing production information, identifying relevant patterns, and providing additional insights during batch assessment.
Customer value.
A data-driven batch release process.
By establishing a reliable communication backbone between production systems and digital decision-support platforms, the customer gains a more connected and data-driven batch release process. Relevant production information is made available in a structured and consistent way, reducing manual data transfers and improving the accessibility and reliability of the information used during batch assessment.
The integration framework enables the customer to fully leverage advanced data analytics and AI capabilities for batch release support, while maintaining a controlled link with the manufacturing environment. This helps decision-makers identify relevant deviations faster, make better-informed decisions, and reduce the risk of delays in the release process.
Meet the expert.
Nele Perdu
Team lead Industrial IT
Co-funded by
EUROSTARS reference number : E!114650
