Vented Vial Adapter with Filtered Air Venting for Sterile Reconstitution
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Solution Overview
Problem
Existing fluid transfer assemblies for liquid drug reconstitution and administration allow septic air to contaminate reconstituted drugs when ambient air is drawn into vials, compromising sterility, especially in non-sterile environments like outpatient clinics and hospitals.
Innovation Solution
A vented female vial adapter with an air filter and vent ports is used, along with a male vial adapter featuring a sealing arrangement to control the opening of vent ports during detachment, ensuring filtered air is drawn to equalize pressure without introducing septic air into the vial, maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a non-vented female vial adapter is used, then the vial remains sealed during detachment, but ambient air is drawn into the vial causing contamination of reconstituted liquid drug
Solution Approach 1:
An air filter is introduced as an intermediary component between the vent port and the vial interior. The filter allows air to pass through for pressure equalization while blocking septic air from entering the vial and contaminating the reconstituted liquid drug, thus resolving the contradiction between needing venting and maintaining sterility
Solution Approach 2:
The harmful function of the vent port (allowing septic air entry) is extracted and isolated by placing an air filter in series. The vent port still serves its pressure equalization function, but the harmful contamination pathway is removed through the filter medium
2Stress or pressure
If vent ports are opened during detachment to equalize pressure, then air can enter to balance vacuum, but septic air contaminates the reconstituted liquid drug
Solution Approach 1:
The air filter serves as a mediator that enables pressure equalization through controlled air entry while preventing septic air from reaching the vial interior. This allows the system to achieve pressure balance without compromising sterility
Solution Approach 2:
The potential harm of septic air entry is converted into a benefit by using the air filter to allow only clean air to enter for pressure equalization. The vent port's function is preserved, but the harmful effect is transformed into a sterile pressure equalization process
3Reliability
If a sealed female vial adapter is used, then sterility is maintained, but pressure equalization cannot occur during detachment
Solution Approach 1:
The venting function is segmented from the main sealed structure by adding discrete vent ports with filters. This allows the majority of the adapter to remain sealed for sterility while providing controlled venting pathways for pressure equalization
Solution Approach 2:
Different parts of the female vial adapter have different properties: the main body remains sealed for sterility, while specific localized vent ports with filters provide controlled air entry for pressure equalization. This local differentiation resolves the contradiction between sealing and venting
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 effectively prevents contamination by allowing filtered air to equalize pressure within the vial, maintaining the sterility of reconstituted liquid drugs during the reconstitution and administration process, enhancing the safety and integrity of the drug delivery system.
Implementation Method 1
a venting arrangement having an air filter and one or more vent ports
Implementation Method 2
providing an otherwise conventional male vial adapter with a sealing arrangement having one or more port sealing members for sealing the vent ports
Implementation Method 3
the prevailing vacuum in the medicament containing vial rapidly draws the diluent from the diluent containing vial thereinto to form a reconstituted liquid drug
Data Source
Figure 1
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AI summary
A fluid transfer assembly including a vented female vial adapter and male vial adapter for use with a pair of vials including a vial with contents under negative pressure for liquid drug reconstitution and administration purposes. The vented female vial adapter includes a venting arrangement and the male vial adapter includes a sealing arrangement for selectively sealing the venting arrangement. The fluid transfer assembly is designed such that only filtered air is drawn into the vial under negative pressure subsequent to reconstitution of liquid drug contents to ensure sterile conditions.