Enclosed Medicine Compounding Kits With Sterile Fluid Pathways

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Solution Overview

Problem

Existing medical compounding kits fail to provide a fully enclosed and sterile environment for handling hazardous medicines, risking contamination and requiring specialized equipment like laminar flow hoods.

Innovation Solution

Convenience kits with pre-sterilized, fully enclosed plastic bags and integrated fluid pathways using Bag Entry with Sterilizing Technology (BEST) or Bag Entry Technology (BET) ensure all fluid communication remains sterile, maintaining Sterility Assurance Level (SAL) without external contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional compounding kits are used in open environments, then ease of operation is improved, but sterility assurance level deteriorates due to contamination risks

Engineering Contradiction:

Improveease of operationVSAvoidsterility assurance level

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent implements a sterile enclosed environment (plastic bag) that creates an isolated atmosphere protected from external contamination. This inert environment allows compounding operations to proceed without laminar flow hoods while maintaining sterility assurance level, resolving the contradiction between ease of operation in open environments and reliability of sterility maintenance.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The patent introduces sterile barriers and filtered access ports as intermediary elements between the sterile internal environment and the non-sterile external environment. These intermediaries enable fluid and instrument transfer while maintaining sterility, allowing easy operation without compromising the sterile field.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If fully enclosed sterile bags with integrated fluid pathways are used, then sterility assurance level is improved, but device complexity increases

Engineering Contradiction:

Improvesterility assurance levelVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple functions (sterile containment, fluid pathways, filtration, and compounding workspace) into a single integrated plastic bag system. This consolidation maintains high sterility assurance level while reducing overall device complexity by eliminating the need for separate laminar flow hoods and multiple standalone components.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The enclosed bag system serves multiple functions simultaneously: it provides sterile containment, houses fluid pathways for reconstitution, offers a protected workspace, and enables hazardous drug handling. This multi-functionality achieves high reliability without proportionally increasing complexity, as one component performs several critical roles.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Object-affected harmful factors

If pre-sterilized enclosed kits are used for hazardous medicines, then safety against contamination is improved, but loss of time increases due to single-use design

Engineering Contradiction:

Improvesafety against contaminationVSAvoidloss of time

Core Design Contradiction:

Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The kits are pre-sterilized and pre-assembled with all necessary components (fluid pathways, filters, containers) before use. This preliminary preparation ensures safety against contamination is built-in from the start, while the single-use design eliminates time-consuming sterilization and setup procedures during actual compounding, thereby reducing overall time loss.

Inventive Principle:

Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The kits enable safe compounding of hazardous medicines in open environments, ensuring the sterility of both the product and container, meeting USP 797 and USP 800 requirements without the need for laminar flow hoods.

Implementation Method 1

Bag Entry with Sterilizing Technology (BEST) which employs a sterilizing grade (0.2 micron) filter as a processing component in the fluid entry pathway of the plastic bag for sterilizing fluids communicated into the bag

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

providing protective procedures and entirely enclosed apparatus for user safety when compounding medicine, especially when compounding hazardous medicines. Such kits can be used in a potentially contaminating environment and still produce a desired product with safety

Methodology Applied

Scientific EffectPhysical containment: Physical Containment

Data Source

PatentUS12350235B2Convenience kits for preparing medicine with an assured level of safety

Publication Date: 2025.07.08 THORNE INTELLECTUAL PROPERTY HOLDINGS LLC

AI summary

A convenience kit being formed by a pair of associated sub-kits which provide capability for bench-top medicine prescription compounding without need for clean room surroundings or such protective equipment as laminar flow hoods. The sub-kits include an exterior sub-kit which provides for access, volumetric measurement and compounding of medicine derived from vials and an enclosing sub-kit housed within a plastic bag which provides a sterile environment for filling a medical treatment vessel for use. The two sub-kits are joined together and communicate by bag entry technology to provide a system which not only protects and, in some cases, provides product sterility, but also assures full containment of all fluid being used in a medical preparation.