Tapered Sterile Transfer Bag for Isolator RTP Systems
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Solution Overview
Problem
The existing methods for transferring sterile goods from a container to an isolator often result in contamination due to contact with non-sterile surfaces, known as the 'Ring of Concern', and require operator intervention within the isolator, making the process cumbersome and risky.
Innovation Solution
A container design with a tapered bag section that widens into a funnel shape, allowing a transfer tube to be inserted without operator intervention, which bridges the 'Ring of Concern' and ensures complete transfer of goods into the isolator by narrowing towards the closed end, preventing retention of material and ensuring sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transfer tube is inserted into the container to prevent contact with non-sterile surfaces, then contamination is prevented, but operator intervention within the isolator is still required making the process cumbersome
Solution Approach 1:
The transfer tube is pre-positioned within the container before docking, with its free end initially located in a first position outside the container opening. After docking, the transfer tube is moved to a second position where its free end extends into the container interior, allowing goods to be transferred through the tube without operator intervention within the isolator.
Solution Approach 2:
The transfer tube serves as an intermediary element that bridges the sterile interior of the container and the isolator environment. It allows goods to be transferred through a controlled path that prevents contact with non-sterile surfaces while enabling operation from outside the isolator.
2Ease of operation
If goods are transferred directly from container to isolator, then the process is simple, but contact with non-sterile surfaces causes contamination
Solution Approach 1:
The transfer tube acts as a sterile intermediary pathway between the container and isolator. Goods are conveyed through this dedicated tube rather than being directly exposed to the isolator environment, preventing contact with non-sterile surfaces while maintaining transfer simplicity.
Solution Approach 2:
The transfer tube is made of flexible material that allows it to be maneuvered between different positions (inside and outside the container) while maintaining its sealing function. This flexibility enables the tube to adapt to the docking configuration while preserving sterility.
3Reliability
If the bag section has a narrow opening to fit the transfer tube, then sterility is maintained, but material retention in the container increases
Solution Approach 1:
The bag section is designed with a dynamically adjustable opening that can widen to accommodate the transfer tube during transfer operations, then return to a narrower configuration. This dynamic behavior allows the opening to adapt between sterility maintenance (narrow) and complete emptying (wide) requirements.
Solution Approach 2:
The bag section is divided into different functional zones: a first section with a narrower opening for maintaining sterility, and a second section with a wider opening for complete material discharge. This segmentation allows each zone to optimize for its specific function while working together to achieve both sterility and complete transfer.
Data Source
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Figure 3
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AI summary
The invention relates to a container (10; 12) for transferring sterile, free-flowing material, in particular cleaned and sterilized small items such as stoppers for infusion bottles and vials, through a rapid transfer port (RTP) system (18) into an isolator (16). The container (10; 12) comprises a flexible, tube-like pouch section (24; 26) with a closed end (28) and an open end (34), as well as a container-side section (22) of the RTP system (18) tightly connected to the open end (34), which can be docked to a complementary isolator-side section (20) of the RTP system (18) for transferring the material. According to the invention, the container (10; 12) comprises a container section (62) whose inner cross-section tapers towards the closed end (28) and which is formed at least partially by the tubular flexible bag part (26).