Premix Compounding Workflow for Error-Safe Parenteral Nutrition

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Solution Overview

Problem

Current methods for compounding parenteral nutrition formulations are prone to errors and contamination due to manual calculations and handling, especially in high-stress hospital environments, where complex calculations and multiple ingredients increase the risk of mistakes and microbial contamination.

Innovation Solution

An automated compounder system that reduces human interaction by preprogrammatically controlling the delivery of additives to a receiving receptacle, using a single fluid interconnection and verifying the receptacle's identity and volume to ensure accurate and safe compounding, minimizing errors and contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual calculations and handling are used for compounding parenteral nutrition formulations, then flexibility in customization is maintained, but error rates increase and contamination risks escalate

Engineering Contradiction:
Improvecompounding accuracyVSAvoidautomation level
Core Design Contradiction:
ReliabilityVSExtent of automation

Solution Approach 1:

The system enables self-service automation where the compounder autonomously performs calculations, verifies ingredient compatibility, controls delivery volumes, and monitors compounding progress without human intervention, thereby eliminating manual errors while maintaining customization capability

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical handling with an automated computer-controlled system that uses electronic manifests, automated calculations, and programmable delivery mechanisms to compound formulations, substituting human operations with automated digital processes

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If multiple fluid interconnections are made during manual compounding, then ingredient additions are flexible, but contamination opportunities increase

Engineering Contradiction:
Improvecontamination riskVSAvoidcompounding process simplicity
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The system merges multiple separate fluid interconnection operations into a single integrated automated process where all ingredient deliveries are managed through one established fluid pathway, eliminating repeated connection/disconnection cycles and associated contamination risks

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The automated system maintains continuous fluid connection throughout the compounding process, allowing seamless delivery of multiple ingredients without breaking the sterile barrier, thereby eliminating contamination opportunities while maintaining operational flexibility

Inventive Principle:
Principle #20Continuity of useful action

3Reliability

If automated compounder systems are implemented, then error rates decrease and patient safety improves, but system complexity increases

Engineering Contradiction:
Improvepatient safetyVSAvoidcompounder system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The automated compounder system performs multiple functions including manifest processing, automated calculations, ingredient compatibility verification, precise volume delivery, and compounding monitoring within a single integrated platform, reducing overall system complexity despite enhanced capabilities

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system uses an electronic manifest as an intermediary that carries all compounding instructions, calculations, and verification data, serving as a central communication hub that coordinates all automated functions and simplifies the overall system architecture

Inventive Principle:
Principle #24Intermediary (Mediator)

4Productivity

If manual compounding protocols are used, then adaptability to individual patient needs is maintained, but productivity decreases due to time-consuming calculations and handling

Engineering Contradiction:
Improvecompounding efficiencyVSAvoidcompounding time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The system performs preliminary automated calculations of ingredient volumes and concentrations based on electronic patient-specific manifests before actual compounding begins, eliminating time-consuming manual computations and enabling rapid preparation while maintaining individualized formulation accuracy

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3451107B1Method for compounding a preparation using a premix solution
Publication Date: 2021.07.14 BAXA CORPORATION
  • EP3451107B1 patent drawingFigure 1A
  • EP3451107B1 patent drawingFigure 1B
  • EP3451107B1 patent drawingFigure 2

AI summary

Computer systems and non-transitory computer readable media for determining an amount of an ingredient for a preparation for a requested therapy (e.g., an order or a prescription) includes an identifier, volume, and amounts of first and second compounds in each of a plurality of premix solutions. A predefined formulary comprising a formulary concentration of each of a plurality of additions is provided. A premix solution is selected. An amount of a first additions to be added to the premix solution may be selected. A number of bags of the premix solution, needed to satisfy a volume associated with the selected premix solution, are optionally reserved. An additive volume is determined at least by the specified first amounts of the first addition and a corresponding formulary concentration.