Sterilized Drug Delivery Device Packaging
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Solution Overview
Problem
Existing methods for sterilizing drug delivery devices, such as syringes, face challenges due to drug sensitivity to sterilization methods like heat, gases, or radiation, and difficulties in achieving complete sterilization, especially in complex device structures with occluded areas.
Innovation Solution
A method involving a package with separate compartments for the prefilled barrel, plunger rod, and finger grip, where the components are physically separated before sterilization, allowing for effective exposure to a sterilant gas like nitrogen dioxide, ensuring thorough sterilization of external surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If components are assembled together before sterilization, then the device structure is simpler to manufacture, but sterilization effectiveness is reduced due to occluded areas
Solution Approach 1:
The package is divided into multiple separate compartments, each designed to hold a specific component (barrel, plunger rod, finger grip) in an unassembled state. This segmentation allows sterilant gas to access all surfaces of each component independently, eliminating occluded areas that would exist if components were assembled together, thereby improving sterilization effectiveness while maintaining manageable packaging complexity.
2Reliability
If sterilant gas is used to sterilize the device, then sterilization can be performed externally after packaging, but the gas may be absorbed by plastics and rubbers negatively impacting the drug product
Solution Approach 1:
The package incorporates a gas-permeable sheet in specific locations (the seal between lid and base) that allows controlled passage of sterilant gas. This localized gas permeability enables the sterilant to reach and sterilize the external surfaces of components through the package structure, while the gas-permeable material is selected to minimize absorption and prevent negative impacts on the drug product inside the barrel.
3Reliability
If the package is sealed tightly to protect the drug product, then drug integrity is maintained, but sterilant gas cannot effectively reach all surfaces for complete sterilization
Solution Approach 1:
The package utilizes a gas-permeable sheet as part of its sealing structure. This thin film material provides both protective sealing functions to maintain drug integrity and allows passage of sterilant gas molecules. The gas-permeable sheet is positioned at the seal between lid and base, enabling sterilant gas to diffuse through the package structure and sterilize external surfaces of components while the sealed compartments continue to protect the drug product from contamination.
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
This method improves the sterilization effectiveness by ensuring all external surfaces of the drug delivery device components are exposed to the sterilant gas, overcoming the limitations of traditional methods and maintaining the integrity of sensitive medications.
Implementation Method 1
one side of the package is formed by a gas-permeable sheet
Implementation Method 2
exposing the sealed package to a sterilant gas under conditions such that external surfaces of the prefilled barrel, the plunger rod and the finger grip are sterilised
Data Source
AI summary
A method for preparing a sterilised drug delivery device (1) comprising a fluid medication, the method comprising the steps of: providing a prefilled barrel (10) containing the fluid medication, the barrel being sealed with a stopper; placing the prefilled barrel, a plunger rod (20) and a finger grip (30) in a package such that the prefilled barrel, the plunger rod and the finger grip are separated from each other, wherein one side of the package is formed by a gas-permeable sheet (40); closing and sealing the package; and exposing the sealed package to a sterilant gas under conditions such that external surfaces of the prefilled barrel, the plunger rod and the finger grip are sterilised, wherein the package is a tray (50) comprising a cavity (51) formed therein wherein the cavity comprises at least three separate compartments (51a, 51b, 51c) adapted to the respective shapes of the components of the device for placement therein, and wherein the each of the prefilled barrel, the plunger rod and the finger grip, respectively, is placed in a corresponding compartment within the tray.