Pharmaceutical Vial Cap System with Piercing Member
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Solution Overview
Problem
Existing cap systems for pharmaceutical vials do not facilitate easy access to the contents after permanent sealing, and they are limited to glass vials due to the requirement of a blowback feature, which restricts the use of materials like plastic.
Innovation Solution
A cap system comprising an elastomeric stopper, retainer member, locking member, and a piercing member that allows the piercing member to be extended through the stopper for access, enabling the use of plastic vials and simplifying the sealing process without the need for a blowback feature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a blowback feature is used on the vial lip to mate with the elastomeric stopper, then the stopper can be kept in place during lyophilization processing, but the vial material is limited to glass and the operation becomes complex requiring sterile conditions
Solution Approach 1:
The sealing system is divided into separate functional components: the elastomeric stopper for sealing, the retainer member with resilient fingers for mechanical retention, and the locking cap member for final securing. This segmentation eliminates the need for the blowback feature on the vial itself, allowing plastic vials to be used while maintaining stopper retention during processing
Solution Approach 2:
The retainer member acts as an intermediary between the stopper and the vial neck. Its resilient fingers engage with the flanged neck to provide mechanical retention of the stopper during processing, replacing the need for the stopper to interact directly with the vial lip through a blowback feature
2Reliability
If the vial is permanently sealed with a complex cap system, then the seal is secure, but access to the contents becomes difficult
Solution Approach 1:
The cap member is designed with dynamic functionality - it can be removed from the piercing member to allow access to the vial contents. The piercing member remains in place maintaining the seal, while the removable cap provides access when needed. This dynamic design resolves the contradiction between maintaining a secure permanent seal and enabling easy access to contents
Data Source
AI summary
A cap system for sealing injectable drugs within a vial is disclosed. The system includes an elastomeric stopper, a retainer member, a locking member, a cap assembly and a piercing member. The retainer member is arranged to snap onto the vial and the locking member slid with respect to the retainer member to permanently seal the vial. The cap assembly includes a cap and a band and is coupled to the locking member. The cap releasably holds the piercing member. The band is arranged to be removed to enable the cap to move the piercing member to penetrate the stopper, whereupon the cap can be removed. The piercing member is arranged to be connected to a syringe or other instrument to withdraw the vial's contents.