Pharmaceutical Pouch Holding Device for Sterilization Contamination Control
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Solution Overview
Problem
The handling of pharmaceutical pouches for sterilization and filling is prone to contamination by solid and chemical particles, and existing storage tools lack organization and replicability, complicating the sterilization process and increasing the risk of microbiological contamination.
Innovation Solution
A holding device with a supporting surface featuring gripping members for parallel positioning of filling tubes or necks, a temporary fastener to prevent particle entry, hooking elements for suspension, and made from materials resistant to irradiation to prevent chemical contamination, facilitating automated handling and storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pouches are handled manually for sterilization and filling, then flexibility in operation is maintained, but contamination by solid particles and chemical substances increases
Solution Approach 1:
The holding device acts as an intermediary tool between manual handling and the sterilization/filling processes. It provides a controlled interface that prevents direct contact between pouches and potential contaminants while enabling automated manipulation, thus reducing contamination risk without completely eliminating human involvement in the process setup and monitoring
Solution Approach 2:
The patent replaces manual mechanical handling with an automated mechanical system consisting of the holding device with gripping members and temporary fasteners. This substitution eliminates human hands from直接接触 the pouches during critical operations, thereby preventing contamination while maintaining operational control through automated mechanisms
2Reliability
If pouches are sterilized before filling, then microbiological contamination is prevented, but contamination by solid particles during handling remains a risk
Solution Approach 1:
The holding device performs preliminary protective actions by equipping pouches with temporary fasteners before sterilization and equipping the device itself with gripping members. These pre-installed components are designed to prevent solid particle contamination during subsequent handling operations, addressing the limitation of sterilization which only covers microbiological contamination
Solution Approach 2:
The solution segments the contamination prevention approach into two distinct components: temporary fasteners that seal pouch openings to prevent solid particle entry, and gripping members that enable contamination-free handling. This segmentation allows each component to address specific contamination risks independently, complementing the sterilization process
3Quantity of substance
If conventional storage tools are used for pouches, then storage capacity is maintained, but organization and replicability for sterilization monitoring are compromised
Solution Approach 1:
The holding device changes the organizational parameters of pouch storage by implementing a standardized grid-like structure with specific positioning for each pouch. This standardized arrangement enables precise monitoring of pouch positions and orientations, which is critical for replicating sterilization conditions, while maintaining adequate storage capacity through efficient space utilization
Solution Approach 2:
The device applies local quality principles by providing specific structural features at critical locations: gripping members at pouch contact points for secure holding, temporary fastener positions at opening areas for contamination prevention, and standardized positioning features throughout the structure. These localized features collectively enable both adequate storage capacity and precise organization for sterilization monitoring
4Reliability
If pouch organization is optimized for sterilization, then sterilization effectiveness is improved, but adaptability to different pouch configurations is reduced
Solution Approach 1:
The holding device incorporates universal features that enable it to handle multiple pouch configurations: adjustable gripping members that can accommodate different tube diameters, standardized positioning systems that work with various pouch sizes, and modular temporary fasteners. These universal features maintain sterilization effectiveness through consistent organization while providing adaptability to different pouch types and configurations
Data Source
AI summary
The invention relates to a device for the automated storage, support and handling of containers for pharmaceutical use, in particular pouches. More particularly, the invention relates to a holding device (10) for containers comprising at least one tube or a filling neck, said device (10) comprising a support surface (100) having a front face defining a front face of the holding device. The front face of the support surface (10) comprises at least one gripping member (200, 200′) for holding a tube or a filling neck of a container that is to be held by said device in a position parallel to the support surface (100). The holding device according to the invention further comprises: ⋅—a temporary closure (300) for opening the at least one tube or filling neck of the container that is to be held by the holding device (10), ⋅—at least one attachment element (40) for securing or suspending the holding device to or on another support. The invention also relates to the use of said holding device.