Snap and Pierce Vial Connector for Aseptic Filling
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Solution Overview
Problem
Current dispensing solutions for PET tracers face challenges in maintaining sterility and leak-tightness when piercing container stoppers, especially when assembled in non-sterile environments, leading to potential contamination and inefficiencies in aseptic filling processes.
Innovation Solution
A 'snap and pierce' device that allows needles to pierce a vial stopper within a sterile bag, using 0.22 µm liquid and gas filters to maintain sterility and prevent leaks, enabling aseptic connection of the dispense needle and vial just before use, even in non-sterile environments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If pre-piercing of the stopper is performed during assembly of the disposable kit in the factory, then the connection between the closed sterile vial and the fluid path is established, but aging of the assembly over time leads to leaks at the piercing holes, compromising sterility
Solution Approach 1:
The piercing device is pre-assembled with needles positioned within the sterile bag, and the stopper is pre-positioned with alignment features. However, the actual piercing action is delayed until immediately before use, resolving the contradiction by performing preliminary preparation without completing the piercing too early. This maintains sterility while enabling quick connection when needed.
Solution Approach 2:
The patent introduces a piercing device as an intermediary component that bridges the sterile vial and the fluid path. This device includes needles, alignment features, and sealing mechanisms that mediate the connection process, allowing reliable sterile connection to be established immediately before use rather than during factory assembly.
2Adaptability or versatility
If piercing is performed outside a sterile environment, then the operation can be conducted in non-class A clean room environments, but the sterility of the fluid path cannot be maintained
Solution Approach 1:
The patent employs a sterile bag (flexible shell) that encapsulates the vial, stopper, and piercing device. This flexible barrier allows the assembly to be handled and prepared in non-sterile environments while maintaining the sterility of the internal components until the moment of piercing, when the connection is immediately established and sealed.
Solution Approach 2:
The piercing device and needles are extracted from the sterile environment only at the moment of use. The vial and stopper remain within the sterile bag throughout preparation, and the piercing action occurs with the system still enclosed, thereby extracting only the necessary piercing function from the sterile environment rather than requiring the entire operation to occur outside it.
3Ease of operation
If a needle pierces the vial stopper to establish fluid connection, then the dispense operation can be performed, but potential leaks at the piercing hole may compromise sterility
Solution Approach 1:
The patent applies local quality by providing enhanced sealing features specifically at the piercing hole location. The stopper includes a recess that receives the needle, and sealing elements are positioned locally at the piercing interface to prevent leaks. This localized sealing approach addresses the harmful leakage effect without complicating the overall connection establishment process.
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 sterile and leak-tight connections during dispensing, minimizing the risk of contamination and extending the capability for aseptic filling to non-class A clean room environments, thereby expanding production sites and maintaining the sterility of pharmaceutical products.
Implementation Method 1
using 0.22 µm liquid and gas filters to maintain sterility
Implementation Method 2
using 0.22 µm liquid and gas filters to maintain sterility
Data Source
Figure 1~3
Figure 4~6
Figure 7
AI summary
A pierce and fill connector cap for a vial sealed by an elastomeric septum includes a vial collar and a needle holder. The vial collar body defines a collar aperture to be positioned in overlying registry with the septum of the vial, and the needle holder includes a needle holder body providing a means for holding an elongate needle in registry with the collar aperture. The needle holder body being moveable with respect to said vial collar between a first position spaced from the vial collar and a second position proximate the vial collar, such that a needle held by the needle holder will puncture through the vial septum.