Transdermal Sheet Mold Shielding Electron Beam Sterilization
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Solution Overview
Problem
The high cost of manufacturing equipment and the risk of pharmaceutical preparation or raw material deterioration during the production of transdermal absorption sheets, particularly when electron beam sterilization is used outside an aseptic environment.
Innovation Solution
A method involving filling needle-like recessed portions of a mold with a polymer solution in an aseptic environment, storing it in a drying container, drying outside the aseptic environment, and using an electron beam shield to prevent beam exposure during sterilization, allowing for cost-effective production while maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If drying is performed outside an aseptic environment to reduce equipment costs, then manufacturing cost decreases, but the risk of contamination increases
Solution Approach 1:
The manufacturing process is divided into two distinct environments: aseptic environment for filling operations and non-aseptic environment for drying operations. The mold acts as a transfer medium between these environments, allowing the process to be segmented spatially and temporally, thus reducing equipment costs while maintaining sterility where critical.
Solution Approach 2:
The filling operation is performed preliminarily in an aseptic environment before drying. By completing the critical sterility-related step (filling) before leaving the aseptic environment, the subsequent drying can occur in a less controlled environment without compromising product sterility.
2Reliability
If electron beam sterilization is applied to the drying container to ensure sterility, then reliability improves, but pharmaceutical preparation may deteriorate due to beam exposure
Solution Approach 1:
The lid serves as an intermediary barrier between the electron beam and the pharmaceutical preparation. It absorbs or blocks the electron beam while allowing sterilization of the container exterior, thus protecting the sensitive pharmaceutical contents from direct beam exposure that would cause deterioration.
Solution Approach 2:
Different parts of the drying container have different electron beam shielding properties. The lid is designed with high shielding capability to protect the pharmaceutical, while other parts may have lower shielding. This local differentiation of shielding quality allows effective sterilization without harmful beam exposure to the drug.
3Object-affected harmful factors
If a shield is placed between the electron beam source and the mold to protect the pharmaceutical, then pharmaceutical safety improves, but the complexity of the sterilization process increases
Solution Approach 1:
The lid serves multiple functions: it acts as the container closure, provides structural support, enables gas permeation for drying, and functions as the electron beam shield. By combining these functions into a single component, the system avoids additional dedicated shielding devices, thus maintaining simplicity while protecting the pharmaceutical.
Solution Approach 2:
The shielding function is merged with the lid structure rather than being a separate component. This integration combines the protective function with the existing container element, reducing overall system complexity while achieving the same level of pharmaceutical protection.
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 reduces equipment costs and prevents deterioration of pharmaceuticals by shielding the electron beam, enabling efficient and cost-effective manufacturing of transdermal absorption sheets.
Implementation Method 1
irradiating a surface of the drying container in which the mold is stored with an electron beam from an electron beam source
Data Source
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AI summary
Provided is a method for manufacturing a transdermal absorption sheet which suppresses the cost of manufacturing equipment and prevents deterioration of a pharmaceutical preparation or a raw material thereof, and an intermediate. A mold filled with a first polymer solution is stored in a drying container in an aseptic environment, and the first polymer solution in the mold stored in the drying container is dried outside an aseptic environment. In a case where a surface of the drying container in which the mold is stored is irradiated with an electron beam from an electron beam source, a shield that shields an electron beam is arranged at a position on a straight line connecting the electron beam source and the needle-like recessed portions.