Aseptic Drug Delivery Device Sterilization via Segmented Assembly
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Solution Overview
Problem
Drug delivery devices with pre-filled liquid drugs face challenges in sterilization due to limitations of conventional methods, such as gaseous sterilization not penetrating sealed environments and heat or radiation damaging device materials, making aseptic assembly costly and impractical.
Innovation Solution
A system and method for aseptic packaging of drug delivery device components using a sterilization enclosure that allows for exposure to sterilization fluids and radiation, enabling the sterilization of components like liquid drug containers, needle conduits, and caps within a radiation shield, while maintaining the integrity of the device and eliminating the need for costly aseptic assembly environments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gaseous sterilization methods (Ethylene Oxide, steam, vaporized Hydrogen Peroxide) are used, then sterilization effectiveness is improved, but penetration into sealed environments is insufficient
Solution Approach 1:
The device is divided into separable components (drug container, needle conduit, cap, plunger) that are sterilized individually before final assembly. This segmentation allows each component to be exposed to sterilization agents effectively, with the fluid path remaining open during sterilization to enable penetration by gaseous sterilants.
Solution Approach 2:
Components are sterilized in advance before final assembly into the sealed device. The sterilization process is performed on individual components with open fluid paths, allowing sterilization agents to penetrate effectively, followed by assembly in a controlled manner that maintains sterility without requiring the final sealed device to withstand harsh sterilization conditions.
2Reliability
If radiation or heat sterilization is used on sealed devices, then internal volumes can be sterilized, but device materials may be damaged
Solution Approach 1:
The device components are separated and sterilized individually before assembly, allowing selective application of sterilization methods. Sensitive components can be sterilized by less harsh methods (e.g., chemical vapor) while other components tolerate more aggressive sterilization, avoiding material damage that would occur if the complete sealed device underwent radiation or high-heat sterilization.
Solution Approach 2:
Different sterilization methods are applied to different components based on their material sensitivity. The patent allows for tailored sterilization approaches where each component receives the most appropriate sterilization method for its specific material composition, rather than subjecting all components to a single harsh sterilization regime.
3Adaptability or versatility
If aseptic assembly is used to sterilize components individually, then sterilization flexibility is improved, but cost increases significantly
Solution Approach 1:
Components are designed to be separable and sterilizable independently, but the final assembly process is simplified to reduce costs. The patent employs a terminal sterilization approach where the assembled device (with open fluid path) undergoes a single sterilization process, eliminating the need for expensive controlled aseptic assembly environments while maintaining sterilization effectiveness.
Solution Approach 2:
The patent combines component assembly with sterilization by performing terminal sterilization on the assembled device structure. Rather than assembling sterilized components in expensive aseptic conditions, the device is assembled with open fluid paths and then sterilized as a complete unit, merging the assembly and sterilization processes to reduce manufacturing costs.
4Reliability
If the device is sealed for intended use, then sterility is maintained, but sterilization options become limited
Solution Approach 1:
The device is assembled with open fluid paths before sterilization, allowing sterilization agents to penetrate the entire fluid path. After sterilization, the device is sealed to maintain sterility. This preliminary open-state assembly enables versatile sterilization method selection while the subsequent sealing preserves the achieved sterility.
Solution Approach 2:
Instead of sealing the device first and then attempting sterilization (which limits options), the patent inverts the sequence: the device is assembled open, sterilized with full penetration, and then sealed. This reversal of the conventional approach expands sterilization method options while ensuring sterility is maintained through the final sealing step.
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
Facilitates effective sterilization of drug delivery device components without damaging the liquid drug, allowing for the use of various sterilization methods and reducing costs associated with aseptic assembly, resulting in a terminally sterilized pre-filled device with a sterile fluid path.
Implementation Method 1
The interior of the sterilization enclosure may be subjected to a sterilization process that may sterilize respective interior portions of the liquid drug container, the needle conduit, and the cap
Implementation Method 2
A downward force may be applied to the liquid drug container to move the mouth portion into engagement with the circumferential lip of the cap
Implementation Method 3
The seal may be crimped to the liquid drug container such that they abut each other
Data Source
AI summary
A method for sterilizing a drug delivery device may comprise disposing a liquid drug container, a needle conduit and a cap in a sterilization enclosure so that a mouth portion of the liquid drug container is registered with, and spaced apart from, a circumferential lip of the cap; disposing a cover over the liquid drug container, the needle conduit, and the cap, sealing the sterilization enclosure; subjecting the interior of the sterilization enclosure to a sterilization process in which the liquid drug container, the needle conduit, and the cap are exposed to the sterilization fluid and are sterilized; and applying a downward force to the liquid drug container to move the mouth portion into engagement with the circumferential lip of the cap and to snap the cap onto the liquid drug container to seal the cap and needle conduit to the liquid drug container in an assembled configuration.