Drug Compounding Skid Sterile Transfer and Automation
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Solution Overview
Problem
Current methods for producing compounded drugs in aseptic environments require manual handling and lack automation, leading to potential contamination and increased labor for sterile transfer and cleaning.
Innovation Solution
A skid apparatus with a frame, sterilization system, and drug transfer system that allows for the sterile transfer of compounded drugs by using valves to form a sterile seal and direct sterilizing steam and fluid for transfer to a holding tank, while also enabling easy cleaning and automation of the compounding process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual handling methods are used for sterile transfer of compounded drugs, then flexibility and simplicity are maintained, but contamination risk increases and labor requirements increase
Solution Approach 1:
A sterile barrier device with a sterile barrier member is introduced as an intermediary between the compounding vessel and storage container. The sterile barrier member includes a first end portion that contacts the compounding vessel and a second end portion that contacts the storage container, allowing transfer of compounded drugs while maintaining sterile isolation. This mediator enables automated or assisted transfer without direct manual handling, reducing contamination risk while maintaining operational simplicity.
2Extent of automation
If automated transfer systems are implemented, then labor is reduced and consistency is improved, but device complexity increases
Solution Approach 1:
The sterile barrier device is segmented into distinct functional portions: a sterile barrier member with a first end portion for contacting the compounding vessel and a second end portion for contacting the storage container. This segmentation allows each portion to be optimized for its specific function while keeping the overall system simple. The modular design enables automated transfer mechanisms to interact with specific portions without requiring complex integration across the entire system.
Solution Approach 2:
The sterile barrier device is designed to be compatible with various compounding vessel types and storage containers, providing universal applicability. The first end portion can interface with different compounding vessel configurations, and the second end portion can connect to various storage container types, allowing a single sterile barrier device design to support multiple automation scenarios without requiring custom-designed components for each application.
3Reliability
If frequent cleaning of compounding vessels is required, then sterility is maintained, but time loss increases and labor increases
Solution Approach 1:
The sterile barrier member is designed to be disposed of or easily replaced after a single use, eliminating the need for time-consuming cleaning and sterilization of the compounding vessel between batches. By performing the cleaning function preliminarily through the disposable sterile barrier, the system avoids repeated cleaning cycles, reducing time loss while maintaining sterility. The sterile barrier is discarded after use, and the compounding vessel is ready for the next compound without additional cleaning steps.
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
The skid apparatus ensures sterile transfer and automation of compounded drugs, reducing contamination risks and labor, while facilitating efficient cleaning and processing.
Implementation Method 1
A sterilization system coupled to the frame and is configured to direct sterilizing steam to contact and sterilize the first valve and the second valve when the vessel is retained by the frame
Implementation Method 2
A drug transfer system is coupled to the frame and is configured to direct fluid such that the fluid passes through the first valve, then through the interior chamber, and then through the second valve to transfer the drug that is compounded within the interior chamber to a holding tank
Data Source
AI summary
A drug compounding skid for sterile transfer of a compounded drug. The skid includes vessels configured to form a sterile seal of a drug contained therein. The skid may include a sterilization system, a drug transfer system, and a cleaning system. The skid may be used to perform sterile transfer of a compounded drug from the vessels to a holding tank. A skid may include a plurality of drug compounding tanks with agitation devices mounted thereto.