Sterile Mixing of Concentrated Composition and Diluent
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Solution Overview
Problem
The existing methods for sterilizing concentrated compositions in clean rooms are either labor-intensive and expensive or result in a short shelf life due to manual dilution, which complicates precise mixing in sterile environments.
Innovation Solution
A method involving the filtration of both the concentrated composition and diluent at 0.2 microns, contained in separate containers within a hermetically sealed bag, which is then irradiation-sterilized and stored in a carton, allowing for precise mixing upon use in a clean room environment without external contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual mixing is performed in clean room by personnel in sterile garments, then sterility is maintained, but mixing is time-consuming and labor-intensive
Solution Approach 1:
The concentrated composition is pre-filled into the container within the sterile environment before leaving the clean room. The diluent is also pre-filled into a separate container. This preliminary preparation eliminates the need for time-consuming manual mixing operations within the clean room, while maintaining sterility through the sealed container system.
Solution Approach 2:
The system enables self-service mixing by providing pre-filled containers that can be easily combined by end users outside the sterile environment. The concentrated composition container is designed to be simple to open and mix with diluent, eliminating the need for specialized clean room personnel or equipment for the mixing operation.
2Manufacturing precision
If concentrated composition is diluted manually in clean room, then proper concentration is achieved, but shelf life of diluted composition is short (17-30 days)
Solution Approach 1:
The concentrated composition is pre-filled into the container within the sterile environment at the optimal concentration for long-term storage. This preliminary preparation ensures the composition remains in its stable, concentrated form during transport and storage, maximizing shelf life while maintaining precise concentration control through the sealed container system.
3Reliability
If aseptically processed sterilization is used, then compositions that cannot be irradiation sterilized are protected, but processing is labor intensive and expensive
Solution Approach 1:
The concentrated composition is pre-sterilized and pre-filled into the container within the sterile environment before leaving the clean room. This preliminary sterilization and filling action eliminates the need for complex aseptic processing equipment or procedures at the point of use, reducing manufacturing complexity while ensuring sterilization effectiveness for compositions that cannot withstand irradiation.
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 sterile mixing of compositions with a diluent, extending shelf life and reducing manual labor, while maintaining sterility and precision in the clean room environment.
Implementation Method 1
The carton is then irradiation sterilized
Implementation Method 2
The diluent is filtered at 0.2 microns and contained in a large container. The concentrated composition is filtered at 0.2 microns
Data Source
AI summary
A method for sterilizing a concentrated composition and a diluent. The diluent is contained in a large container, and the concentrated composition is contained in a small container that is positioned within the large container. The combined containers are placed in at least one sealing layer that is hermetically sealed, and is also preferably placed in a second sealing layer that is also hermetically sealed. The bagged container is then placed in a carton, which preferably has a liner, and the carton is closed. The carton is then irradiation sterilized. The carton is delivered to the clean room. At a first staging area, the carton is opened and the bagged container is removed and brought to a second staging area. At the second staging area, the second sealing layer is removed and the container can be stored in the first sealing layer. The container is brought into the clean environment, where the first sealing layer is removed. At that point, the small container is opened and the chemical composition is released into the large container, so that the chemical composition mixes with the diluent. The container can then be shaken until the chemical composition is thoroughly mixed with the diluent.