Aseptic Vial Piercing Assembly With Pre-Sterilized Flowpath
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Solution Overview
Problem
Current methods for sterilizing vial septums before needle insertion are inefficient and prone to contamination, requiring additional steps like alcohol wipes, which are impractical when the container is inside a delivery device.
Innovation Solution
A method and system for assembling and sterilizing an aseptic vial piercing mechanism by integrating a flowpath forming member with a primary container, where the system is terminally sterilized using a sterilant and UV light, ensuring a sterile environment without the need for additional wipes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an alcohol wipe is used to sterilize the vial septum before needle introduction, then the sterile environment is maintained, but the process complexity increases and contamination risk remains if not properly performed
Solution Approach 1:
The system performs sterilization of the flowpath forming member and second cavity in advance through terminal sterilization during manufacturing, before the product is assembled with the primary container. This preliminary sterilization eliminates the need for alcohol wiping at the point of use, maintaining reliability while reducing process complexity.
Solution Approach 2:
The invention extracts the sterilization function from the point-of-use process and relocates it to the manufacturing stage. The flowpath forming member and second cavity are sterilized separately during manufacturing, and this sterilized component is then assembled with the primary container in a non-sterile environment, removing the alcohol wipe step from the administration process.
2Reliability
If alcohol wiping is performed on the vial septum, then sterilization is achieved, but additional time is required for this extra step
Solution Approach 1:
The sterilization of the flowpath forming member and second cavity is performed in advance during manufacturing through terminal sterilization processes. This eliminates the time-consuming alcohol wiping step at the point of use, maintaining sterilization effectiveness while significantly reducing the time required for the administration process.
3Stability of the object's composition
If the container is inside a delivery device, then protection and stability are improved, but alcohol wiping becomes impractical
Solution Approach 1:
The invention extracts the sterilization function from the point-of-use operation and relocates it to the manufacturing stage. The flowpath forming member and second cavity are sterilized during manufacturing, and this sterilized assembly is then integrated with the primary container within the delivery device. This allows the container to remain protected inside the delivery device while eliminating the need for accessible alcohol wiping.
Solution Approach 2:
The sterilization of components that will be housed inside the delivery device is performed in advance during manufacturing. This preliminary sterilization ensures that components remain sterile even when enclosed in the protective delivery device, maintaining both protection and sterility without requiring accessible wiping operations.
4Reliability
If traditional sterilization methods are used, then sterility is achieved, but the risk of contamination during assembly increases
Solution Approach 1:
The invention extracts the sterilization function from the final assembly process and performs it separately on the flowpath forming member and second cavity during manufacturing. This allows the primary container to be assembled with the sterilized components in a non-sterile environment without compromising sterility, as the critical flowpath components were already sterilized and sealed. This eliminates the contradiction between achieving sterility and minimizing contamination risk during assembly.
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
Ensures a sterile environment during needle insertion into vials without additional sterilization steps, preventing contamination and maintaining aseptic conditions throughout the process.
Implementation Method 1
injecting a sterilient through the flowpath forming member and thereby into the second cavity
Implementation Method 2
The opening may be configured to vent positive pressure such that the injected sterilient flushes out the atmosphere within the flowpath forming member and the second cavity
Implementation Method 3
injecting an inert gas through the flowpath forming member and, thereby into the second cavity to flush out the sterilient from the flowpath forming member and the second cavity
Implementation Method 4
The opening of the boot portion forms a sliding seal about the flowpath forming member
Data Source
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AI summary
The present disclosure provides aseptic vial piercing and sterilization systems, and methods of assembling, using and sterilizing same. The systems and methods utilize a pre-sterilized primary container including a first end, a first cavity, a second end with an opening in communication with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The systems and methods include an injection assembly including a first end portion of a hollow flowpath forming member. The injection assembly and the primary container may be assembled in a non-sterile environment to form a second cavity extending about the first end portion of the flowpath forming member and to the primary container. The second cavity may then be selectively sterilized in a non-deleterious manner to the product to allow the first end portion to aseptically pierce the septum to extend into the first cavity.