Aseptic Closure System for Medicinal Fluids
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current aseptic filling methods for medical liquids require extensive equipment and energy due to the need for heat sterilization, which is inefficient and costly, especially for large-volume containers.
Innovation Solution
A closure system with a fixing piece, connection piece, and a displaceable closure piece that allows for aseptic filling and sealing without heat sterilization, utilizing a protective cap to minimize contamination and energy usage by transferring only the closure into a higher clean-room class for filling, reducing the need for extensive clean-room handling of the entire container.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If heat sterilization is used for sterilization of solution containers, then sterilization effectiveness is improved, but energy consumption and processing time increase significantly
Solution Approach 1:
The container and closure are pre-sterilized separately before assembly, allowing sterilization to be performed under optimal conditions without the energy-intensive heat treatment required during filling. The closure includes a protective cap that maintains sterile conditions during transfer and filling operations.
Solution Approach 2:
The invention replaces thermal sterilization with mechanical/physical barriers including sterile filters in the filling device, protective caps on the closure, and controlled clean-room environments to maintain sterility without requiring heat treatment of the liquid or container.
2Reliability
If heat sterilization is used for sterilization of solution containers, then sterilization effectiveness is improved, but processing time increases due to long heating phases
Solution Approach 1:
Sterilization is performed in advance on empty containers and closures separately, allowing parallel processing and eliminating the need for time-consuming heating during the filling operation. The protective cap maintains sterility during the brief transfer period.
Solution Approach 2:
The invention skips the time-intensive heat sterilization step during filling by relying on pre-sterilization and protective barriers, enabling rapid transfer and filling operations without compromising sterility.
3Reliability
If the entire container is handled in a high clean-room class environment, then contamination risk is reduced, but equipment complexity and operational difficulty increase
Solution Approach 1:
The system divides the sterile barrier function across multiple components: the pre-sterilized container, the closure with protective cap, and the filling device with sterile filter. This allows only the closure to be handled in the high clean-room class environment during transfer, rather than the entire container.
Solution Approach 2:
The protective cap on the closure acts as an intermediary that maintains sterile conditions during transfer, allowing the closure to be moved through the high clean-room class environment without requiring the entire container to be handled there.
4Reliability
If heat sterilization is used for sterilization of large-volume containers, then sterilization effectiveness is improved, but equipment requirements and energy outlay increase
Solution Approach 1:
Large-volume containers are pre-sterilized empty before use, eliminating the need for in-place heat sterilization during filling. This avoids the complex equipment required to heat and pressurize large containers during the filling process.
Solution Approach 2:
The invention replaces the complex thermal sterilization equipment required for large-volume containers with simpler pre-sterilization infrastructure and protective barriers, significantly reducing equipment requirements while maintaining sterilization effectiveness.
Data Source
AI summary
The present invention relates to a closure for filling and sealing receptacles containing medicinal fluids, a method for filling a receptacle with a medicinal fluid and sealing the receptacle. The closure used in the method comprises a mounting piece that may be attached to the receptacle and a connector piece that may be connected to a connector piece of a filling device. A closure body is arranged between the mounting piece and the connector piece, in which a closure piece for sealing the closure sits. The closure piece may be slid between a position sealing the closure and a position which opens the closure. The closure is sealed tight with a removable protective cap. The present method is characterized in that with the protective cap removed the receptacle is filled through the closure in a clean room, whereupon after filling, the closure is sealed by pressing the closure piece into the closure.