Fill-Finish Assembly Sterilization via Segmented Carrier
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Solution Overview
Problem
Conventional drug delivery devices require pre-sterilization of internal components, which is challenging when pre-filled with a drug due to potential damage from high-energy beams and risk of contamination during assembly, necessitating patient or healthcare provider sterilization steps.
Innovation Solution
A fill-finish assembly and method that maintains a sterilized internal fluid flow pathway by connecting the insertion mechanism, fluid pathway connection assembly, and container before filling, using a carrier to align and secure these components for standard fill-finish equipment compatibility and sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high-energy beams (x-rays or electron beams) are used for terminal sterilization of the drug delivery device, then the internal components are properly sterilized, but the drug stored in the container is damaged
Solution Approach 1:
The internal fluid pathway components (container, insertion mechanism, fluid pathway connection assembly) are sterilized before filling with the drug. This preliminary sterilization allows the use of high-energy beams to effectively sterilize the components without exposing the drug to damaging radiation, as the drug is filled after sterilization.
Solution Approach 2:
The device is divided into sterile internal components (container, insertion mechanism, fluid pathway connection assembly) that can be sterilized separately before filling, and the drug-filled container that is assembled afterward. This segmentation allows sterilization of components without exposing the drug to harmful radiation.
2Ease of manufacture
If the pre-filled drug container and fluid pathway components are installed in a non-sterile environment, then assembly is simplified, but microbes or contaminants may contaminate the exterior connection surfaces
Solution Approach 1:
The internal fluid pathway components are sterilized before assembly in the non-sterile environment. By performing sterilization as a preliminary action on the components before they are installed, the system maintains sterility of the critical internal pathways even though the final assembly occurs in a non-sterile setting.
Solution Approach 2:
The sterilization process is extracted and performed separately on the internal components before assembly, rather than attempting to maintain a sterile environment throughout the entire assembly process. This allows simplified assembly while still achieving sterilization of critical components.
3Ease of operation
If the device is pre-loaded with a pre-filled drug container, then patient or healthcare provider preparation steps are eliminated, but manufacturing complexity increases due to sterilization challenges
Solution Approach 1:
The internal fluid pathway components are sterilized as a preliminary action before filling with the drug and final assembly. This approach simplifies the manufacturing process by allowing standard sterilization techniques to be applied to components in advance, eliminating the need for complex terminal sterilization procedures on the complete assembled device.
Solution Approach 2:
The manufacturing process is segmented into separate stages: sterilization of internal components, filling with drug, and final assembly. This segmentation allows each step to be optimized independently, reducing overall manufacturing complexity compared to attempting to sterilize the complete assembled device with pre-filled container.
Data Source
AI summary
Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly. The carrier may be configured to hold the container, the insertion mechanism, and the fluid pathway connection assembly in alignment with each other.