Single-Use Bioprocess Device Sterilization with Gamma and Steam
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Solution Overview
Problem
Ensuring microbiological purity of disposable filtration devices for bioprocesses is challenging due to materials unsuitable for gamma sterilization, leading to contamination risks during assembly and potential damage from superheated steam sterilization.
Innovation Solution
A method involving separate sterilization processes for gamma-sterilizable and non-gamma-sterilizable components, using sterile barriers and closures to protect medium-contacting areas, followed by rapid assembly to minimize contamination risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separation units are sterilized with superheated steam to ensure microbiological purity, then sterilization is achieved, but plastic deformation occurs and tightness is lost
Solution Approach 1:
The disposable device is divided into two distinct groups: gamma-sterilizable components (container, connecting tubes, connectors) and non-gamma-sterilizable separation units (filters, membranes, chromatography columns). This segmentation allows each group to receive appropriate sterilization treatment - gamma radiation for heat-sensitive components and autoclaving for separation units - thereby achieving sterilization without causing plastic deformation to the separation units.
Solution Approach 2:
The separation units are extracted from the overall sterilization process and treated separately from the gamma-sterilizable components. By removing the separation units from the gamma sterilization pathway and subjecting them to autoclaving instead, the invention avoids the plastic deformation issue while maintaining the sterilization effectiveness for these critical filtration and separation components.
2Shape
If gamma radiation sterilization is used to maintain dimensional stability, then component dimensions are preserved, but separation unit materials lose mechanical stability
Solution Approach 1:
The device components are segmented into two sterilization categories: those suitable for gamma radiation (container, tubes, connectors) and those requiring autoclaving (separation units with PTFE, PP, PVC, PE materials). This segmentation ensures that each material type receives the sterilization method that preserves its mechanical stability, preventing the degradation that would occur if gamma radiation were applied to heat-sensitive polymer materials.
Solution Approach 2:
Different sterilization methods are applied to different local regions or components of the disposable device based on their specific material properties. The gamma-sterilizable components receive gamma radiation treatment, while the separation units with sensitive materials receive autoclaving. This localized approach to sterilization ensures that each component's mechanical stability is preserved according to its material characteristics.
3Reliability
If separate sterilization processes are used for different components, then material suitability is maintained, but assembly complexity increases
Solution Approach 1:
The gamma-sterilizable components are sterilized by gamma radiation before assembly, and the separation units are sterilized by autoclaving before assembly. By performing these sterilization actions preliminarily and separately, the invention simplifies the final assembly process - the components are already sterile when brought together, eliminating the need for complex in-situ sterilization procedures during assembly while maintaining material suitability.
Solution Approach 2:
The invention introduces sterile barriers and protective coverings as intermediaries during the assembly process. These intermediaries maintain sterility without requiring complex sterilization procedures during assembly, allowing separate sterilization of components to be efficiently coordinated. The sterile barriers act as mediators that preserve microbiological purity while simplifying the assembly workflow.
4Ease of operation
If the disposable device is sterilized as a whole after assembly, then user burden is reduced, but components not suitable for the same sterilization method cannot be processed
Solution Approach 1:
The disposable device is segmented into components that can be sterilized by different methods before final assembly. The container, connecting tubes, and connectors are sterilized by gamma radiation, while separation units are sterilized by autoclaving. This segmentation enables the manufacturer to deliver a complete, sterile, pre-assembled device to the user without burden, while accommodating the diverse sterilization requirements of different materials through targeted, component-specific sterilization processes.
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
Ensures microbiological purity and maintains component integrity by reducing contamination exposure time and preventing particle ingress, allowing for safe and efficient assembly of complex disposable devices.
Implementation Method 1
sterilizing the gamma-sterilizable component and the gamma-sterilizable separation unit(s) by gamma radiation
Implementation Method 2
sterilizing the non-gamma-sterilizable separation unit(s) with superheated steam
Data Source
Figure 1
Figure 2~3
Figure 4~6
AI summary
In a method for ensuring microbiological purity of a single-use device (10) for carrying out a biotechnological process, the single-use device (10) comprises at least one gamma-sterilisable component, which is formed from materials suitable for sterilisation using gamma radiation, and at least one sub-component, which is not gamma-sterilisable and contains material unsuitable for sterilisation using gamma radiation. Both the component and the sub-component each have a region that, when the biotechnological process is being carried out, comes into contact with a process medium. The method comprises the following steps: a) sterilising the gamma-sterilisable component using gamma radiation; b) protecting the medium-contacting region of the gamma-sterilisable component using a sterile barrier; c) sterilising the sub-component that is not gamma-sterilisable using superheated steam; d) protecting the medium-contacting region of the sub-component that is not gamma-sterilisable using a sterile barrier; e) removing the sterile barriers; and f) installing the gamma-sterilised component and the superheated-steam-sterilised sub-component in the single-use device (10) immediately after removing the sterile barriers.