Topographical Profiler for Aseptic Closure Nest Verification
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Solution Overview
Problem
Current pharmaceutical container filling and sealing technologies face challenges in maintaining aseptic conditions, managing nested containers, and ensuring equipment cleanliness, particularly for highly potent products, due to complexities in design and handling of elastomeric stoppers and aluminum crimp caps, which can lead to contamination and operational inefficiencies.
Innovation Solution
A method and system for aseptically filling and sealing pharmaceutical containers using articulated arm apparatuses to handle and process nested containers within a controlled environment, incorporating a closure nest with spring-loaded retaining structures for simultaneous capping and stoppering, and a topographical profiler for monitoring closure presence and suitability, ensuring aseptic conditions and efficient processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional vibratory bowls and chutes are used for handling elastomeric stoppers and aluminum crimp caps, then the equipment can process singulated containers, but blockages occur and operator intervention is required frequently
Solution Approach 1:
The patent applies nesting by placing multiple stoppers and caps inside nested containers (vials) in a hierarchical arrangement. The stoppers are positioned inside the vials, and caps are placed over the stoppers, creating a compact nested structure that eliminates the need for separate handling mechanisms and prevents blockages during transport and processing.
2Productivity
If complex filling equipment is used to process nested containers, then the equipment can handle multiple containers, but the equipment cannot be integrated in a controlled environment enclosure and cleaning becomes difficult
Solution Approach 1:
The patent segments the filling equipment into modular components that can be easily assembled, disassembled, and sterilized. The system uses separate modules for container handling, filling, and sealing, each designed to be independently cleanable and suitable for integration within controlled environment enclosures, thereby maintaining productivity while reducing cleaning complexity.
3Ease of manufacture
If nested containers are used to improve handling efficiency, then the containers can be cleaned and sterilized at the manufacturing site, but denesting is required to process containers in singulated fashion
Solution Approach 1:
The patent applies preliminary action by pre-arranging stoppers and caps inside the nested containers during the manufacturing process. The stoppers are inserted into the vials and caps are placed over them while the containers are still nested, so that when the containers are later unnested, the closures are already in position and require no additional handling or adjustment during the filling process.
4Reliability
If vibratory bowls and chutes are sterilized in an autoclave, then the stopper surfaces are sterilized, but it is practically impossible to transfer the sterilized components aseptically from the autoclave to the processing environment
Solution Approach 1:
The patent merges the sterilization and processing environments by integrating the vibratory bowl and chute systems directly within the controlled environment enclosure. This allows the components to be sterilized in place along with the entire processing environment, eliminating the need for separate autoclave sterilization and aseptic transfer operations, thereby maintaining reliability while improving ease of operation.
Data Source
AI summary
The present invention involves both an apparatus and an associated method for confirming the presence or absence of closures in a closure nest inside an aseptic chamber. The apparatus comprises a topographical profiler disposed to monitor the closure nests. Vertical displacements in topographical maps obtained by the profiler are compared with information from a database about the nest and closure combinations. Vertical displacements falling outside predetermined upper and lower bounds are deemed absences of closures. The topographical profiler may be disposed outside the aseptic chamber. The system may be automated via a controller and suitable software. In some embodiments the nests and disposed in the monitored area by robotic articulated arms. In other embodiments the closure nests are moved by vacuum pickup systems. The system and method may also be employed to assess the suitability of a closure nest for closing in an aseptic chamber containers in a container nest.