Capped Syringe Barrel Coating for Integrity Testing
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Solution Overview
Problem
Existing pharmaceutical packages and medical devices, such as syringes and cartridges, face challenges in maintaining container closure integrity and preventing material leaching between the package contents and the vessel wall, which can lead to microbiological contamination and reduced shelf life.
Innovation Solution
A vapor-deposited coating is applied to the internal wall of the barrel of a capped pre-assembly, using chemical vapor deposition to create a barrier layer that isolates the contents from the vessel wall, while allowing for easy pressure testing to ensure container closure integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vapor-deposited coating is applied to the internal wall of the barrel, then material leaching and contamination are prevented, but the device complexity increases
Solution Approach 1:
The vapor-deposited coating is applied to the internal wall of the barrel before filling the syringe with pharmaceutical contents. This preliminary protective measure ensures that the barrel material cannot leach into the contents and prevents microbiological contamination, thereby maintaining container closure integrity without requiring additional complex components during the filling process.
Solution Approach 2:
The vapor-deposited coating acts as an intermediary barrier layer between the barrel wall and the pharmaceutical contents. This intermediate layer prevents direct contact between the contents and the barrel material, thereby preventing material leaching and contamination while maintaining the structural integrity of the original barrel design.
2Ease of manufacture
If the pre-assembly is capped before coating application, then the coating process is simplified, but pressure testing becomes more difficult
Solution Approach 1:
The cap is placed on the pre-assembly before the vapor-deposited coating is applied to the internal wall of the barrel. This preliminary capping simplifies the coating process by defining the coating chamber and preventing contamination during deposition. The cap is subsequently removed to allow access for pressure testing, ensuring that the simplified manufacturing process does not compromise testing capability.
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
The vapor-deposited coating effectively prevents material leaching and contamination, ensuring the sterility and shelf life of pharmaceutical contents by creating a reliable barrier within the pharmaceutical packages and medical devices.
Implementation Method 1
A vapor-deposited coating is applied to the internal wall of the barrel of a capped pre-assembly, using chemical vapor deposition to create a barrier layer
Data Source
AI summary
A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, optionally a dispensing portion, and a cap. The cap is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the cap. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication from the barrel lumen to the exterior via the front opening, optionally further via the dispensing portion lumen if present, at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.