Two-Chamber Carpule Bevel for Sterile Mixing
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Solution Overview
Problem
Two-chamber carpules containing liquid and dry powder formulations cannot be sterilized using moist heat processes, which is the most effective method for ensuring sterility, due to the integrated nature of their components, and require aseptic manufacturing to maintain sterility.
Innovation Solution
A two-chamber carpule design with separate chambers for the liquid and dry powder components, featuring a beveled transition area that allows unhindered movement of a plug between the chambers while ensuring a tight connection, enabling separate moist heat sterilization of the liquid component and maintaining sterility through aseptic manufacturing processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate chambers are used for liquid and dry powder components, then moist heat sterilization of the liquid component becomes possible, but the device complexity increases
Solution Approach 1:
The carpule is divided into two separate chambers: a proximal chamber for the liquid component and a distal chamber for the dry powder component. This segmentation allows the liquid chamber to undergo terminal moist heat sterilization while the dry powder chamber is manufactured aseptically, thereby resolving the contradiction between achieving high sterility assurance and maintaining device simplicity.
2Ease of operation
If a bevel is added to the transition area, then plug movement is facilitated, but the manufacturing precision requirements increase
Solution Approach 1:
A bevel is applied locally at the transition area between the proximal and distal chambers. This localized geometric modification creates a smooth surface transition that facilitates plug movement without requiring high precision throughout the entire device, thereby resolving the contradiction between ease of operation and manufacturing precision requirements.
Data Source
AI summary
The disclosure provides a two-chamber carpule comprising two-chambers adapted to be joined together. Each chamber is adapted to contain a medicament component. The carpule further comprises a bevel arranged on a circumference of at least one of the chambers in a transition area. The bevel extends from one chamber to the other chamber.