Sterile Basket Transfer for Isolator Contamination Prevention
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Solution Overview
Problem
The transfer of sterile particulate bulk materials from a container to an isolator often results in contamination due to contact with non-sterile surfaces, and existing solutions require additional equipment like movable chutes or flap valves, which increase costs and space requirements.
Innovation Solution
The use of a basket within the container that can be moved into an inclined position inside the isolator, allowing the material to slide or fall without contacting non-sterile surfaces, eliminating the need for a chute and flap valve, and incorporating a support for maintaining the desired angle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a movable chute and glove are provided within the isolator to guide material past the ring of concern, then contamination risk is reduced, but device complexity and cost increase
Solution Approach 1:
A sterile basket acts as an intermediary carrier to transfer material from the container to the isolator. The basket maintains sterile barrier integrity during transfer, eliminating the need for complex movable chutes and gloves within the isolator. The basket is introduced through the RTP system and positioned to allow material discharge without contacting non-sterile surfaces.
2Reliability
If a flap valve is provided in the container to prevent material transfer before chute positioning, then contamination is prevented, but device complexity and space requirements increase
Solution Approach 1:
The basket is positioned and secured within the container before the RTP system is opened. This preliminary positioning ensures that the sterile barrier is already in place, eliminating the need for a flap valve mechanism. The basket remains confined to the container until the sterile transfer pathway is established.
3Productivity
If the container is turned over to transfer material, then transfer is achieved, but the ring of concern on annular flanges causes contamination risk
Solution Approach 1:
The sterile basket serves as a mediator between the container and isolator environments. Material is transferred into the basket within the sterile container, then the entire basket is moved through the RTP system into the isolator. This eliminates direct contact between material and the non-sterile ring of concern on the annular flanges during transfer.
4Reliability
If additional equipment like movable chutes and flap valves is added, then transfer safety is improved, but cleaning and sterilization becomes more difficult
Solution Approach 1:
The transfer system is segmented into distinct sterile and non-sterile zones separated by the RTP system. The basket is designed as a separate, removable component that can be independently sterilized. This segmentation simplifies cleaning and sterilization procedures compared to integrated complex mechanisms like movable chutes and flap valves.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method ensures safe and contamination-free transfer of materials without additional equipment, facilitating easier cleaning and sterilization within the container and reducing space requirements during transfer.
Implementation Method 1
the basket is moved out of the container through the filling and emptying opening and the open RTP into an inclined position inside the isolator in which position the material can slide or fall by itself downwardly out of the basket
Data Source
AI summary
The invention relates to a process and a container (10) for transporting a sterile, particulate bulk material and for transferring the material from the container (10) into an isolator (14). The container comprises a filling and emptying opening (24) and a beta part (18) of an RTP system for docking to a complementary alpha part (16) of the RTP system on the isolator. After the opening of the RTP, the material is transferred into the isolator. According to the invention the material is transported in a basket (26) inside the container and when it is transferred after the opening of the RTP, the basket is moved at least partially out of the container and through the open RTP into an inclined position in the interior (80) of the isolator in which position the material can slide or fall by its own downwardly out of the basket.