Aseptic Filling Machine Control Parameter Segmentation
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Solution Overview
Problem
The complexity and cost of monitoring a large number of critical control parameters (CCPs) in aseptic filling machines, which increases with machine complexity, leading to inefficiencies and reliability issues.
Innovation Solution
Classifying control parameters into supercritical and subcritical categories, allowing only supercritical parameters to be monitored during production, with subcritical parameters checked during a pre-production test, reducing the number of parameters that need continuous monitoring and data storage requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If all control parameters are monitored continuously during production phase, then aseptic integrity and regulatory compliance are ensured, but device complexity and cost increase significantly
Solution Approach 1:
The patent segments control parameters into two categories: critical control parameters (CCPs) that require continuous monitoring during production, and non-critical control parameters that are monitored only during pre-production sterilization phase. This segmentation allows the system to maintain aseptic integrity through continuous CCP monitoring while reducing overall monitoring complexity by limiting non-CCP monitoring to the pre-production phase only.
Solution Approach 2:
The patent implements periodic monitoring of non-critical control parameters during the pre-production sterilization phase, followed by continuous monitoring of only critical parameters during production. This periodic action pattern reduces the burden of continuous monitoring while ensuring that non-critical parameters are verified before production begins, thereby maintaining reliability without excessive complexity.
2Reliability
If all control parameters are saved on legal data recorder, then regulatory compliance is achieved, but data storage requirements and costs increase
Solution Approach 1:
The patent extracts non-critical control parameters from the continuous monitoring and data storage requirement during production phase. These non-CCP parameters are monitored and recorded only during the pre-production sterilization phase, and their data is stored separately or temporarily. This extraction significantly reduces the volume of data that must be continuously stored on legal data recorders while maintaining regulatory compliance for critical parameters.
Solution Approach 2:
The patent applies periodic monitoring and recording of non-critical parameters during pre-production phase only, rather than continuous recording during entire production. This periodic action reduces the total data volume stored on legal data recorders while ensuring regulatory compliance through adequate documentation of critical parameters throughout production.
3Adaptability or versatility
If machine complexity increases, then functionality and control capabilities improve, but the number of control parameters and monitoring requirements increase rapidly
Solution Approach 1:
The patent segments the large number of control parameters associated with complex machine functionality into critical and non-critical categories. This segmentation allows the system to maintain advanced functionality with numerous sensors and control capabilities while managing complexity by requiring continuous monitoring and data storage only for critical parameters, thereby making complex machines more manageable and cost-effective.
Data Source
AI summary
A method for controlling the operation of an aseptic product filling machine includes the steps of performing a pre-production test procedure during a pre-production phase in which at least a set of subcritical control parameters are measured, diagnosed and stored, checking if those subcritical control parameters are within their range, starting a production phase if all of the subcritical control parameters are indeed within their range, and measuring, diagnosing and storing a set of supercritical control parameters and not the subcritical control parameters during the production phase.