Disposable Isolator Joining Parts for Automated Pharmaceutical Handling
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Solution Overview
Problem
Existing disposable isolators for pharmaceutical product conditioning face design constraints and increased costs due to the need for precise manipulations and complex integration of filling mechanisms, which complicates their use and maintenance, especially in automated production chains.
Innovation Solution
A disposable isolator design featuring a flexible peripheral wall and pairs of joining parts that securely connect containers to a support table and manipulating tools to robots, allowing for precise positioning and automated manipulation without the need for extensive cleaning or recalibration, enabling efficient and sterile handling of hazardous products.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a disposable isolator is designed with integrated filling means and flexible peripheral walls to enable precise manipulations, then the manipulation precision and sterility are improved, but the device complexity and manufacturing cost increase
Solution Approach 1:
The isolator is divided into separate functional modules: a rigid support table for stable container positioning, a flexible peripheral wall for sealing and adaptability, and interchangeable joining parts for connecting manipulating tools. This segmentation allows each component to be optimized independently, reducing overall complexity while maintaining precision.
Solution Approach 2:
The joining parts are designed with universal interfaces that can connect different manipulating tools (filling needles, stoppers, caps) to the isolator. The first pair of joining parts interfaces with the support table, while the second pair interfaces with manipulating tools, creating a universal system that handles various pharmaceutical products without requiring custom-designed isolators for each application.
2Productivity
If a permanent isolator is used for pharmaceutical conditioning, then the equipment can be reused and initial investment is reduced, but time-consuming cleaning and validation steps are required between productions
Solution Approach 1:
The isolator is designed as a disposable single-use device that is pre-sterilized and qualified before use. After completing one production batch, the entire isolator is discarded rather than cleaned and revalidated. This eliminates time-consuming cleaning and validation steps between productions, significantly improving production efficiency while maintaining product sterility and quality.
Solution Approach 2:
The isolator is pre-sterilized and pre-qualified during manufacturing before reaching the customer. All necessary sterilization and validation actions are performed in advance during production, so that when the isolator is used, it is already ready for immediate use without requiring additional cleaning or validation steps at the customer site.
3Stability of the object's composition
If a disposable isolator is designed with fixed rigid structures to ensure stability, then the structural stability is improved, but the adaptability to different manipulating tools and containers is reduced
Solution Approach 1:
The isolator combines rigid and flexible elements: a rigid support table for stable container positioning is merged with a flexible peripheral wall for sealing and adaptability. The rigid base provides structural stability while the flexible wall and interchangeable joining parts provide adaptability to different manipulating tools and container types.
Solution Approach 2:
The isolator incorporates dynamic elements including a flexible peripheral wall that can adapt to different tool insertions, and interchangeable joining parts that can be configured for different manipulating tools. This dynamic design allows the structurally stable rigid support table to work with various flexible interfaces, achieving both stability and adaptability.
Data Source
AI summary
A disposable isolator including a bottom, a flexible peripheral wall defining a clean and sterile inner volume, a first pair of joining parts forming a first tight junction at the bottom, this first pair including an inner part placed inside the inner volume and suitable for positioning containers, and an outer part placed outside the inner volume and suitable for cooperating by shape matching with a positioning cavity provided on a support table, and a second pair of joining parts forming a second tight junction at the peripheral wall and including an outer part suitable for being connected to a robot, and an inner part suitable for being connected to a manipulating tool, the first and second pairs being designed so that the robot applies the manipulating tool on the containers positioned on the support table.