Vacuum-Packed Vial Tray Handling for Sterile Upright Installation
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Solution Overview
Problem
Existing methods for transporting thermoplastic resin vials under sterile conditions and in an exogenous pyrogen-free state face issues with vials tipping or dropping during handling, particularly when using a rigid sheet to support the vials.
Innovation Solution
A method involving vacuum-packing vials in a tray with a soft film, enclosing them in a gas-impermeable flexible film bag, depressurizing the bag to a specific vacuum pressure, and sealing it to maintain sterility, followed by tearing the bag at a tear notch to release the vials and inverting the tray to stand the vials upright.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid sheet is used to support vials during transport, then the vials can be transported under sterile conditions, but the vials are pulled by the rigid sheet and tipped over or dropped
Solution Approach 1:
The patent replaces the rigid sheet with a flexible film that conforms to the shape of the vials and tray. The flexible film is stretched over the tray and vials, creating a secure fit that prevents vials from tipping or dropping while maintaining sterility. The flexibility allows the film to adapt to the contours of the vials rather than imposing rigid constraints that cause pulling and instability.
Solution Approach 2:
The flexible film acts as an intermediary between the vials and the external environment. It provides a barrier that maintains sterility while allowing secure handling and transport. The film mediates the interaction between the vials and the tray, preventing direct contact issues that occur with rigid sheets while still providing the necessary support and protection.
2Reliability
If thermoplastic resin vials are washed and heated to sterilize them, then sterilization is achieved, but the vials cannot withstand the required temperatures
Solution Approach 1:
The patent replaces the thermal sterilization process (heating to high temperatures) with an alternative sterilization method. The flexible film packaging system allows for sterilization through means other than high-temperature heating, such as radiation or chemical sterilization, which do not require the thermoplastic resin vials to withstand extreme temperatures. This substitution enables sterilization of temperature-sensitive materials.
Solution Approach 2:
The patent changes the sterilization parameters from high-temperature thermal processing to alternative sterilization conditions. By modifying the sterilization approach to use methods compatible with thermoplastic resin's temperature limits, the system achieves sterilization without exposing the vials to temperatures they cannot withstand.
3Reliability
If thermoplastic resin vials are irradiated with radiation to sterilize them, then sterilization is achieved, but drying requires a long time making it difficult to carry out washing on the filling assembly line
Solution Approach 1:
The patent performs preliminary sterilization of the flexible film packaging and tray before the vials are placed inside. This allows the vials themselves to be transferred directly into the sterile environment without requiring subsequent washing and drying steps on the assembly line. The sterile barrier is prepared in advance, eliminating time-consuming drying processes.
Solution Approach 2:
The patent replaces the washing and drying process with a direct transfer method into a pre-sterilized environment. Instead of using water washing followed by extended drying time, the system uses the flexible film packaging as a sterile barrier that allows direct placement of vials, eliminating the need for washing and drying steps entirely.
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 the vials are transported and installed without tipping or dropping, maintaining sterility and exogenous pyrogen-free conditions, suitable for filling assembly lines.
Implementation Method 1
depressurizing the inside of the flexible film bag to a prescribed vacuum pressure so that the flexible film bag surrounds at least the soft film and the tray and fixes them
Implementation Method 2
carrying out sterilization by radiation after the step (V)
Data Source
AI summary
To provide a method for transporting thermoplastic resin vials under sterile conditions and in an exogenous pyrogen-free state, introducing the vials into a filling assembly line, and thereafter allowing the vials to stand without tipping or dropping them, the method is a method for packing vials for filling with contents such as medicaments or cells by vacuum-packing the vials, and includes the following steps:(I) inserting a plurality of vials in a tray with opening portion sides of the vials facing a bottom of the tray,(II) installing a soft film on bottom portions of the vials,(III) introducing the tray having the vials installed therein and the soft film into a gas-impermeable flexible film bag,(IV) depressurizing the inside of the flexible film bag to a prescribed vacuum pressure, and(V) sealing an opening of the flexible film bag.