Medicament Reconstitution Bag With Spike Filter
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current bags used for conditioning, reconstitution, and dilution of injectable products often compromise aseptic integrity due to particle contamination from cork puncturing, lack of safe handling, and inadequate identification of medicaments, leading to potential embolization and granuloma formation risks.
Innovation Solution
A bag design featuring a spike with a built-in filter for particle retention, a bottle locking system for secure identification and attachment, and luer lock attachments to prevent particle generation and ensure safe fractioning, along with a safety device that prevents bottle separation from the bag.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a spike is used to puncture the cork for reconstitution, then the medicament can be transferred from the bottle to the bag, but particle contamination occurs causing embolization and granuloma risks
Solution Approach 1:
A filter is introduced as an intermediary component between the spike and the bag cavity. The filter captures particles generated during cork puncturing and medicament transfer, preventing them from entering the diluent solution. This resolves the contradiction by enabling the necessary puncturing operation while eliminating the harmful particle contamination through the filtering intermediary.
2Adaptability or versatility
If the bottle is easily detachable from the bag, then the system is flexible and reusable, but accidental or intentional product exchanges cannot be prevented
Solution Approach 1:
The bottle is equipped with a safety device and identification system before connection to the bag. The safety device creates an irreversible mechanical connection upon attachment, and the identification system records product information in advance. This preliminary preparation ensures that once connected, the bottle cannot be accidentally or intentionally removed, preventing product exchanges while maintaining initial flexibility.
Solution Approach 2:
The safety device implements a preliminary anti-action by designing a one-way locking mechanism that prevents bottle detachment after attachment. The mechanical interlocking features and irreversible connection elements are built into the system before use, actively counteracting any potential separation forces or intentional removal attempts, thus ensuring product security.
3Productivity
If traditional cork puncturing methods are used, then the procedure is simple and fast, but particle generation compromises aseptic integrity
Solution Approach 1:
The filter serves as a mediator that does not significantly slow down the reconstitution process while effectively capturing particles. The filter is positioned to intercept particles at the source of contamination during the puncturing and transfer operation, allowing the procedure to remain simple and fast while eliminating particle generation hazards.
4Device complexity
If no filter is used during cork puncturing, then the device complexity is low and operation is simple, but particle contamination occurs
Solution Approach 1:
The filter is integrated into the spike assembly as a compact intermediary component. This addition increases device complexity only minimally while providing substantial protection against particle contamination. The filter's small size and integration into the existing spike structure allow it to be added without significantly complicating the overall device or operation.
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 solution ensures aseptic handling and secure identification of injectable products, reduces particle contamination, and prevents accidental or intentional product exchanges, thereby enhancing patient safety by maintaining the sterility and integrity of the medicament during preparation and administration.
Implementation Method 1
a spike with a built-in filter for particle retention
Data Source
Figure 1~2
Figure 3~4
Figure 5~6
AI summary
A bag is disclosed for storing, reconstituting and/or diluting injectable products, and a safety device for use in a bottle for a medicament to be reconstituted and/or diluted in a bag for storing, reconstituting and/or diluting injectable products. The present invention patent relates to a bag (1) for storing a liquid substance (SL) used for reconstituting and/or diluting a medicament (M); the bag (1) has two accesses, so-called inlet (3) and outlet (4), both containing closing devices for releasing or stopping the flow of a liquid that flows into or out of the bag (1). The inlet (3) comprises a filtering element for retaining particles possibly produced by the coring phenomenon which can occur when the spike (20) of the inlet ruptures the plug (40) of the bottle (37) . The present patent also comprises a safety device (2) used for permanently attaching the bottle (37) to the inlet (3). The bag (1) allows the substance contained therein to be used either entirely in a single volume or in a fractionated manner.