Syringe Pack Plunger Constraint for Sterilization Pressure
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Solution Overview
Problem
Existing syringe packs face challenges in maintaining sterility during external sterilization, particularly when using high pressure variations, as stopper movement can compromise the integrity of the dosage chamber, risking contamination and drug quality.
Innovation Solution
A syringe pack design featuring a packaging system with a containment part that fixes the barrel in place and a constraining structure blocking the plunger's distal movement, minimizing stopper movement and ensuring sterility through pre-compression of the dosage chamber, allowing for external sterilization with varying pressures without compromising the contents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external sterilization is performed with high pressure variation, then sterilization effectiveness is improved, but stopper movement occurs which compromises sterility and drug quality
Solution Approach 1:
The packaging applies a pre-compression force to the plunger rod in the distal direction before sterilization, creating a counteracting force that prevents stopper movement during pressure variation. This preliminary anti-action ensures the stopper remains stationary despite the harmful pressure changes during sterilization.
Solution Approach 2:
The packaging structure is designed to pre-position and secure the plunger rod and stopper in a fixed state before the sterilization process begins. By establishing this preliminary stable configuration, the system prevents stopper movement during subsequent pressure variations, maintaining sterility throughout the process.
2Adaptability or versatility
If the plunger is allowed to move freely during sterilization, then pressure variation can be applied for effective sterilization, but the stopper may move and compromise the dosage chamber integrity
Solution Approach 1:
The packaging applies a localized compressive force specifically to the plunger rod, creating a region of pre-compression that counteracts pressure variation effects. This localized quality change allows the rest of the system to experience full pressure variation for effective sterilization while the critical plunger-stopper region remains stable.
3Ease of manufacture
If no constraining structure is used, then the packaging is simple and easy to manufacture, but stopper movement occurs during external sterilization compromising drug quality
Solution Approach 1:
The packaging introduces a constraining structure that acts as an intermediary between the external sterilization environment and the syringe components. This mediator absorbs and counteracts the harmful effects of pressure variation, protecting the stopper and dosage chamber while allowing effective sterilization to proceed.
Data Source
AI summary
A syringe pack with a prefilled syringe (1) and a packaging (2) comprises: a barrel part (11) with an orifice (113) at a proximal end and a flange portion (112) at a distal end; a plunger part (13) extending through the distal end of the barrel part (11) into the barrel part (11); a stopper (12) adjacent to a proximal end of the plunger part (13) and arranged inside the barrel part (11) such that a dosage chamber (111) is formed inside the barrel part (11); and a drug substance arranged inside the dosage chamber (111), wherein the prefilled syringe (1) is arranged in the packaging (2) and the packaging (2) is configured to allow external sterilization of the prefilled syringe (1) arranged in the packaging (2). The packaging (2) comprises a containment part (21) having a fixing structure (211) which holds the barrel part (11) of the prefilled syringe (1) in a defined fix position; a constraining structure (23) which acts on the plunger part (13) of the prefilled syringe (1) to block a movement of the plunger part (13) of the prefilled syringe (1) in a distal direction; and a cover part (22) tightly closing the containment (21).