Automated Solid Medicament Production Module with Batch Tracking
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Solution Overview
Problem
Current semi-continuous pharmaceutical powder processing systems rely on manual operation, leading to handling errors, safety risks, and product loss due to granulate compaction and equipment failures, with inadequate automation for process control and quality tracking.
Innovation Solution
A fully automated production module for solid medicaments that includes a supply device, mixing device, final processing device, and control device, enabling automated process parameter management, real-time tracking, and quality assurance through a network of connected units with collecting locks and quality sensors, eliminating manual intervention and ensuring product traceability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual operation is used for connecting and disconnecting containers and process units, then ease of operation is maintained, but handling errors occur and safety risks increase
Solution Approach 1:
The system performs automatic cleaning of process units without manual intervention. The control device automatically controls the cleaning device to clean process units after production, eliminating the need for manual cleaning operations while maintaining thorough cleaning effectiveness.
Solution Approach 2:
Manual mechanical operations for connecting containers, operating process units, and cleaning are replaced by an automated control system. The control device receives coded information from containers and automatically controls all process units, substituting manual mechanical operations with automated control mechanisms.
2Ease of operation
If intermediate storage containers are used for granulate, then ease of operation is improved, but granulate compaction and sticking occur causing product loss
Solution Approach 1:
The system eliminates intermediate storage containers and implements continuous automatic transfer of granulate directly from the granulating process unit to the next process unit. This continuous action prevents granulate from remaining stationary and compacting, thereby avoiding product loss while maintaining operational ease through automation.
3Manufacturing precision
If series connection of fluidized-bed apparatuses is used, then manufacturing precision is improved, but reliability decreases due to single point of failure
Solution Approach 1:
The system segments the production process into multiple independent process units that can operate autonomously. Each process unit can be individually controlled and cleaned, and the system can switch between different units if one fails, preventing single-point-of-failure issues while maintaining manufacturing precision through dedicated functionality of each unit.
4Productivity
If fully automated production module is implemented, then productivity is improved, but device complexity increases
Solution Approach 1:
The control device serves multiple functions: it receives coded information from containers, controls all process units sequentially, monitors production parameters, and operates the cleaning device. This multi-functionality consolidates what would otherwise require multiple separate control systems, reducing overall system complexity while maintaining high productivity through full automation.
Data Source
AI summary
A production module for producing solid medicaments in individual batches, comprising a supplying device for supplying powdered starting materials, a mixing device connected to the feeding device and is intended for working the supplied powdered starting materials into a product, a final working device connected to the mixing device and is intended for the final production of an end product from the worked starting materials, and a control device for automatically controlling the supplying device and the mixing device and the final working device. Diverters allow a batch to be passed on from the supplying device to the mixing device and from the mixing device to the final working device without any backmixing. Data of all the process sensors and quality sensors of the production module are linked with the respective batch by the control device such that tracking and tracing of the batches is made possible.