Nested Closure Filling for Aseptic Pharmaceutical Containers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing pharmaceutical container filling and sealing technologies face challenges in maintaining aseptic conditions, managing nested containers, and ensuring cleanability within controlled environment enclosures, particularly for highly potent products, while avoiding unnecessary handling and preventing contamination.
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, filling, and sealing of pharmaceutical containers, with closure nests designed to hold closures frictionlessly and facilitate simultaneous processing of multiple containers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional vibratory bowls and chutes are used for handling closures, then closures can be singulated and transported, but blockages occur and operator intervention is required
Solution Approach 1:
The patent removes closures from the problematic vibratory bowl/chute system and places them directly into nests within the controlled environment. This extraction eliminates the blockage-prone vibratory mechanisms from the aseptic zone, allowing continuous operation without operator intervention to clear blockages.
Solution Approach 2:
The patent uses nests to hold multiple closures in a compact, organized arrangement within the controlled environment. Closures are placed in nests before entering the aseptic zone and remain in these nests throughout the filling process, eliminating the need for vibratory singulation and transport mechanisms that cause blockages.
2Adaptability or versatility
If nested containers are processed in singulated fashion, then traditional equipment can be used, but benefits of nesting are foregone
Solution Approach 1:
The patent employs dynamic robotic arms that can adapt to handle nested containers in their nested configuration. The robotic system dynamically adjusts its gripping and manipulation methods to process multiple nested containers simultaneously, maintaining the productivity benefits of nesting while using modern automated equipment.
Solution Approach 2:
The patent introduces nests as intermediary carriers that hold multiple containers in a nested arrangement. These nests serve as the interface between the containers and the robotic handling system, allowing the robot to manipulate groups of containers as single units while still accessing individual containers when needed.
3Reliability
If vibratory bowls and chutes are sterilized, then aseptic conditions can be maintained, but transfer from autoclave to processing environment is impossible
Solution Approach 1:
The patent extracts the sterilization requirement from the handling equipment (vibratory bowls and chutes) and applies it instead to the nests and robotic arms. The nests are sterilized separately and then transferred to the controlled environment, while the robotic arms perform all handling operations within the aseptic zone, eliminating the need to transfer sterilized vibratory mechanisms.
Solution Approach 2:
The patent replaces the mechanical vibratory bowl and chute system with a robotic arm system that uses controlled, programmed movements to handle containers and closures. This substitution eliminates the need for complex sterilization and transfer procedures associated with vibratory mechanisms while maintaining aseptic conditions through robotic precision and sealed environments.
4Ease of operation
If conveyor belts are used to convey nested containers, then containers can be transported, but cleanability becomes problematic
Solution Approach 1:
The patent removes conveyor belts from the controlled environment and replaces them with robotic arms that transfer nested containers through sterile barriers. This extraction eliminates the cleanability problems associated with conveyor belts, as the robotic system uses sealed transfer mechanisms that can be sterilized and do not require extensive cleaning maintenance.
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.