Electron Beam Sterilization of Flexible Plasma Bags
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Solution Overview
Problem
Current electron-beam sterilization methods for flexible bags containing human plasma protein solutions are inadequate as they fail to effectively sterilize the thicker areas, such as the twist-off caps, due to insufficient energy penetration, leading to potential contamination risks.
Innovation Solution
A sterilization device employing a combination of electron accelerators emitting beams with energies between 400-500 keV and 4-5 MeV, arranged at the top of the device to emit electron beams perpendicular to the ground, with enhanced containment measures to prevent radiation escape, ensuring thorough sterilization of the bag components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electron beam energy is increased to penetrate thicker areas like twist-off caps, then sterilization effectiveness is improved, but radiation containment requirements and device complexity increase
Solution Approach 1:
The patent changes the energy parameter of the electron beam from conventional levels (450-500 keV) to high energy levels (4-5 MeV). This parameter change enables the beam to penetrate thick areas like twist-off caps (up to 3 mm) and bag walls (130 μm) effectively, achieving complete sterilization while managing radiation containment through directional emission perpendicular to the ground
2Device complexity
If electron accelerators are arranged to emit beams parallel to the ground, then device simplicity is maintained, but radiation escape risk increases
Solution Approach 1:
The patent inverts the conventional horizontal arrangement of electron accelerators to a vertical configuration. Instead of emitting beams parallel to the ground, the accelerators are positioned to emit beams perpendicular to the ground (downwards). This inversion enables effective penetration of thick bag components while the vertical orientation, combined with containment walls, prevents radiation escape into the surrounding environment
3Reliability
If electron beam energy is increased fivefold to 4 MeV, then penetration depth and sterilization completeness are improved, but energy consumption and equipment requirements increase
Solution Approach 1:
The patent implements a significant change in the energy parameter of the electron beam, increasing it from 450-500 keV to 4-5 MeV (approximately 10 times higher energy). This parameter change is necessary to achieve complete sterilization of thick areas like twist-off caps and multi-layer bag walls. The high energy enables the beam to penetrate these thick components and deliver sufficient absorbed dose to eliminate microorganisms throughout the entire bag structure
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 method achieves complete sterilization of flexible bag components, including the twist-off caps, by increasing the electron beam energy to 4 MeV, five times higher than the previous standard, ensuring safety and efficacy in preventing microbial contamination.
Implementation Method 1
Electron-beam irradiation, also known as 'E-beam', is a form of ionising radiation which is generally characterised by low penetration and high doses of applied energy. Said beam is a stream of concentrated and highly charged electrons. These electrons are generated by an accelerator capable of producing beams which may be continuous or pulsed. The material to be sterilized absorbs the energy of the electrons and said energy absorption, also known as absorbed dose, eliminates microorganisms by destroying their DNA strands.
Data Source
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AI summary
This invention relates to the pharmaceutical sector, specifically to an improved device for electron-beam irradiation sterilisation of flexible bags, in particular the type of flexible bags that may contain human plasma protein solutions for therapeutic use. This device comprises two electron accelerators: a first accelerator emitting an electron beam with energies between 400 and 500 keV and a second accelerator emitting an electron beam with an energy of at least 4 MeV. In addition, the present invention relates to a sterilisation method by electron-beam irradiation of such flexible bags and to an in-line filling process for flexible bags using the sterilisation device and method of this invention.