Nested Pharmaceutical Container Filling With Simultaneous Closure Alignment
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Solution Overview
Problem
Existing pharmaceutical container filling and sealing technologies face challenges in maintaining aseptic conditions, managing nested containers within controlled environments, and ensuring equipment cleanliness, particularly for highly potent products, while avoiding unnecessary handling and blockages.
Innovation Solution
A method and system utilizing articulated arm apparatus to handle sealed nested materials within a controlled environment enclosure, including decontamination and aseptic gripping, followed by simultaneous filling and sealing of containers and closures using nested nests with spring-loaded retaining structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional vibratory bowls and chutes are used for handling closures, then singulation of closures is achieved, but blockages occur and operator intervention is required
Solution Approach 1:
The closure handling system is segmented into multiple independent tracks that can operate simultaneously. Each track handles a specific closure type or size, preventing blockages by distributing the load and allowing independent operation of each segment. This segmentation eliminates the single-point failure mode of traditional vibratory bowls.
Solution Approach 2:
Guiding rails and transfer mechanisms serve as intermediaries between closure storage and the filling station. These intermediaries smoothly guide closures through the system, preventing direct contact between vibratory elements and closures, thereby eliminating blockages while maintaining reliable continuous operation.
2Adaptability or versatility
If nested containers are processed in singulated fashion, then traditional equipment compatibility is maintained, but benefits of nesting are foregone
Solution Approach 1:
The system dynamically adapts its handling mechanism based on container configuration. When nested containers are detected, the system switches to a nest-handling mode that processes multiple containers simultaneously. When singulated containers are detected, it switches to individual processing mode, thereby maintaining versatility while maximizing productivity.
Solution Approach 2:
The filling equipment is designed with universal handling capabilities that can accommodate both nested and singulated containers using the same articulated arm apparatus. This multi-functionality allows the system to process nested containers efficiently without requiring separate equipment, thereby maintaining adaptability while improving productivity.
3Ease of operation
If conveyor belts are used to convey nested containers, then container transport is achieved, but cleaning challenges arise
Solution Approach 1:
The conveyor belt system is extracted and replaced with articulated arm apparatus that grasps and transports nested containers. This removal of the conveyor belt eliminates the cleaning challenges associated with belt surfaces, crevices, and joints while maintaining efficient container conveyance through robotic manipulation.
Solution Approach 2:
The articulated arm apparatus is designed with self-cleaning capabilities through its open mechanical structure. The components have no hidden crevices or difficult-to-reach surfaces, allowing them to be easily cleaned and sterilized in place, thereby maintaining ease of operation while solving the cleanability problem.
4Ease of operation
If vibratory bowls and chutes contact stoppers, then stopper transport is achieved, but sterilization is required
Solution Approach 1:
The mechanical vibratory bowl and chute system is replaced with an articulated arm apparatus that uses controlled robotic motion to transport stoppers. This substitution eliminates the need for sterilization by avoiding direct contact between stoppers and complex mechanical surfaces, thereby maintaining ease of operation while reducing device complexity.
Solution Approach 2:
The articulated arm serves as an intermediary that transports stoppers without direct surface contact. The arm's gripper mechanism holds stoppers in a controlled manner, eliminating the need for sterilization of extensive surface areas while maintaining efficient stopper handling.
Data Source
AI summary
In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligned concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.


