Pharmaceutical Container Closure Bonding for Sterility
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Solution Overview
Problem
Existing primary packaging containers for pharmaceutical substances face challenges such as increased manufacturing complexity, material costs, contamination risks, and design limitations due to separate production and mounting of closures, which can lead to leakage and germ inclusion.
Innovation Solution
A primary packaging container design where the closure is materially bonded or micro-positively connected to the hollow body without auxiliary fastening, allowing for a single-process injection molding production that reduces contamination risks and enhances design flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the closure is separately produced and mounted on the hollow body, then the manufacturing process allows for modular assembly and repair, but the manufacturing complexity increases, production time lengthens, and contamination risks increase
Solution Approach 1:
The patent merges the hollow body and closure into a single integrated component manufactured through one-shot injection molding. The closure is formed as an integral part of the hollow body during the same manufacturing process, eliminating separate production and assembly steps. This reduces manufacturing complexity while maintaining the functional benefits of a closure system.
Solution Approach 2:
The integrated closure structure performs multiple functions: it seals the hollow body, provides a mounting surface for septums or caps, and maintains structural integrity. The single manufacturing process produces a component that combines the functions of both the container body and closure mechanism.
2Ease of manufacture
If the closure is separately produced and mounted on the hollow body, then the components can be manufactured independently, but the production time increases and automation becomes more difficult
Solution Approach 1:
The closure structure is prepared in advance as an integral part of the hollow body during the injection molding process. The molded-in features such as recesses, protrusions, or threading are formed simultaneously with the main body, eliminating the need for subsequent assembly operations and enabling faster production.
3Ease of manufacture
If the closure is separately mounted on the hollow body, then the components can be replaced independently, but the contamination risk increases and sterilization becomes more difficult
Solution Approach 1:
By integrating the closure into the hollow body as a single component, the patent eliminates the interfaces and seams where contamination could occur during assembly. The seamless construction reduces the risk of germ inclusion and particle contamination while maintaining the ability to replace the entire container unit if needed.
4Reliability
If the hollow body has a flanged rim for closure mounting, then the closure can be securely attached, but the design freedom and shape variations are limited
Solution Approach 1:
The patent incorporates closure mounting features such as recesses, protrusions, or threading only in the specific local region where the closure needs to attach. This allows the rest of the hollow body to have free-form shapes and variations without being constrained by the need for a standardized flanged rim throughout the entire structure.
Solution Approach 2:
Instead of relying on a two-dimensional flanged rim, the patent uses three-dimensional integrated features formed during injection molding, such as molded-in recesses or protrusions, that provide secure closure attachment while allowing greater shape flexibility in other dimensions of the hollow body.
5Ease of operation
If the closure uses detachable connection with the hollow body, then the closure can be removed and reattached, but the sealing reliability decreases and leakage risk increases
Solution Approach 1:
The closure and hollow body are pre-connected through integral molding that creates permanent bonding interfaces. This preliminary bonding during manufacturing ensures reliable sealing without the need for detachable connections, eliminating leakage risks associated with repeated assembly and disassembly.
Data Source
AI summary
A primary packaging container for pharmaceuticals is provided. The container includes a hollow body, an opening, and a closure. The hollow body has an opening and is made of a cycloolefin polymer or a cycloolefin copolymer. The closure has a puncture region. The closure closes the opening with the puncturing region at the opening. The puncturing region is configured to allow introduction of a cannula into the hollow body and resealing the hollow body upon withdraw of the cannula. The closure has an elastomer that is connected to the hollow body so as to be not separable in a non-destructive manner.