Granulator
A pharmaceutical granulator supplies critical process data such as temperature and pressure, which must be captured and documented without gaps. IoT collects this data securely and makes deviations visible immediately.
Granulator at a glance
Most frequent in the solution examples on this page
Solution examples featuring Granulator
Connecting a pharmaceutical granulator in line with GMP
In the solution example, mixers, granulators, tablet presses, filling and packaging machines are the central data sources, controlled via PLC, SCADA and DCS. Temperature, pressure, mixing time, viscosity and fill volume are recorded. secunet edge acts as the local data gateway at each site and also as a security gateway with a firewall and a layer 2 mode without its own IP address, so older machines can be connected by retrofit as well. soffico's low-code platform Orchestra, running in a Docker environment, processes the data in near real time and passes it to the quality management system.
The user is a leading company in the pharmaceutical industry, working with secunet Security Networks and soffico. Every day, millions of data points are generated there by a machine park ranging from old equipment to state-of-the-art plants. The solution documents every change to the data automatically, and audit trails make it traceable. Batch management records every production step for each batch. Dashboards show the production performance of all lines. According to the solution example, the result is less manual documentation effort, less downtime, more stable production and a high level of confidence in audits.
Pharmaceutical granulators: frequently asked questions
Which data from pharmaceutical granulation is critical?
Critical values are process parameters such as temperature, pressure, mixing time, viscosity and fill volume. They determine product quality and active ingredient concentration. In the solution example, sensors and controllers on mixers, granulators and tablet presses record these values continuously. Quality testing devices also monitor physical and chemical properties of the products, such as active ingredient concentration and shelf life.
How do connected granulators meet GMP requirements?
By documenting all production data automatically, encrypted and tamper-proof. Manual documentation carries a high risk of errors and can lead to compliance violations. In the solution example, soffico's Orchestra stores the data in an auditable format, documents every change and generates audit trails. Batch management records each production step for every batch, which ensures traceability.
Can older granulators be connected retrospectively?
Yes, older machines can be integrated into modern IT/OT environments by retrofit. In the solution example, secunet edge protects the machines at network level. In layer 2 mode without its own IP address, they remain in their original network configuration. secunet's Content Central Management App manages the gateways centrally and harmonises security settings, even across several thousand devices.
How does granulator process data reach quality management?
Via an edge gateway at the machine and an integration platform that forwards the data. secunet edge pre-processes the data on site so deviations are detected quickly. soffico's low-code platform Orchestra handles integration into the central quality management system. Connectors can be configured through a graphical interface and data mappings, even without programming experience.
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