MES Batch System Event Coupling for Pharmaceutical Validation

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Solution Overview

Problem

Current batch systems in pharmaceutical production lack reliable reporting and validation processes, leading to human errors and increased costs due to the close relationship between equipment and master recipes, requiring frequent re-validation and complex recipe modifications.

Innovation Solution

A method and system where a Manufacturing Execution System (MES) is communicatively coupled with a batch system to receive events from the plant floor, allowing the MES to start specific workflows based on these events, thereby decoupling equipment changes from master recipe updates and simplifying validation processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If equipment changes are made at the plant floor level, then adaptability and versatility improve, but device complexity and validation requirements worsen due to the close relationship between equipment and master recipes

Engineering Contradiction:

Improveequipment change capabilityVSAvoidmaster recipe management complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system segments the relationship between equipment and master recipes by introducing an event-driven architecture. Equipment changes are handled as discrete events that trigger specific workflows, rather than requiring comprehensive master recipe modifications. This segmentation allows equipment adaptability while maintaining recipe stability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary layer (the event processing system) between equipment changes and master recipes. When equipment changes occur, events are generated and processed through this intermediary layer, which determines whether master recipe updates are actually needed. This mediator decouples the direct relationship between equipment and recipes, reducing unnecessary complexity.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If frequent re-validation is performed to ensure compliance, then reliability improves, but loss of time and productivity worsen

Engineering Contradiction:

Improvecompliance validationVSAvoidre-validation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system implements feedback mechanisms where events from equipment are automatically processed and validated through defined workflows. This automated feedback loop ensures compliance is maintained continuously without requiring manual re-validation cycles, thus preserving reliability while minimizing time loss.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent establishes validation rules and workflows in advance, before compliance issues arise. By pre-configuring the event processing logic and validation criteria, the system can automatically handle compliance verification when events occur, eliminating the need for time-consuming ad-hoc re-validation while maintaining reliability.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If manual reporting and documentation are used, then ease of operation improves, but reliability worsens due to human errors in reporting

Engineering Contradiction:

Improvemanual reportingVSAvoidreporting accuracy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system enables self-service automated reporting where equipment automatically generates and transmits events to the MES without manual intervention. This self-service mechanism eliminates human errors in data transcription and reporting while maintaining operational simplicity through automated workflows.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the mechanical process of manual reporting and documentation with an automated electronic event-driven system. Events are automatically captured, transmitted, and processed by the MES, substituting human manual operations with automated computational processes that eliminate reporting errors while maintaining ease of use.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Adaptability or versatility

If complex master recipe modifications are made to accommodate equipment changes, then adaptability improves, but device complexity and difficulty of detecting and measuring worsen

Engineering Contradiction:

Improverecipe adaptabilityVSAvoidrecipe validation complexity

Core Design Contradiction:

Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

The system introduces dynamic event-driven workflows that adapt to equipment changes without requiring static master recipe modifications. The event processing architecture allows the system to dynamically respond to equipment states and changes, maintaining recipe adaptability while avoiding the complexity of manually modifying and tracking numerous recipe variations.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS10331114B2Method and system for producing a pharmaceutical product using a MES

Publication Date: 2019.06.25 SIEMENS AG

AI summary

A method produces a pharmaceutical product using a manufacture execution system (MES), and an automation system, such as a batch system. The automation system is configured to drive and to monitor production machines located at a plant floor level. The method is characterized in that it communicatively couples the MES with the automation system, it receives at the MES from the automation system at least one event representative of a situation that has occurred at the plant floor level and relative to the machines, and it depends on the event received at the MES starting at least one workflow controlled by the MES.