Pharmaceutical Filling Machine Sterile Environment Segmentation
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Solution Overview
Problem
Existing machines for filling and closing pharmaceutical containers in controlled-atmosphere environments face contamination risks due to the movement and displacement of plastic support elements like tubs and nests, which can release particles or powders onto the containers before closure.
Innovation Solution
A machine with a unique layout featuring a second sterile work environment and conveyor system that separates the filling and closing operations from the support element movement, ensuring that containers are filled and closed within a completely distinct and separate sterile environment, preventing contamination from support elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If support elements (tubs and nests) are moved and displaced within the sterile work environment, then the filling and closing operations can be performed, but contamination risks increase due to particle or powder release onto the containers
Solution Approach 1:
The machine is divided into two distinct sterile work environments: a first sterile environment for support element preparation and a second sterile environment for container filling and closing. This segmentation isolates the contamination source (moving support elements) from the sensitive operation (container filling), allowing both operations to proceed without cross-contamination while maintaining productivity.
2Device complexity
If a single sterile work environment is used for both support element handling and container filling, then device complexity is reduced, but contamination risks arise from support element movement
Solution Approach 1:
The sterile work environment is segmented into two separate controlled zones with distinct functions. The first zone handles support element movement and preparation, while the second zone performs container filling and closing. This segmentation adds structural complexity but eliminates contamination risks by physically separating the contamination source from the sensitive operation.
Solution Approach 2:
The support element handling operations are extracted from the container filling environment. By removing the source of contamination (moving plastic support elements) from the sterile filling zone, the patent eliminates the harmful effect while maintaining necessary production functions in a separate controlled environment.
3Object-affected harmful factors
If support elements remain stationary outside the sterile environment, then contamination is prevented, but the complexity of transferring containers increases
Solution Approach 1:
Containers are extracted from support elements in the first sterile environment and transferred to the second sterile environment for filling. This extraction removes containers from the contamination-prone support element handling zone while maintaining sterile conditions throughout the transfer process, preventing contamination without requiring support elements to remain completely stationary.
Data Source
AI summary
A machine for filling and closing pharmaceutical containers disposed in respective supports has a sterile first work environment with an inlet passage and an outlet passage, a conveyor transporting the supports, which crosses the work environment through the inlet passage and the outlet passage, and a collecting station in the work environment, for collecting and extracting the containers from the supports. The work environment has a second outlet passage. A sterile second work environment has an inlet and an outlet, the inlet being at the second outlet passage of the first work environment to define a common passage. Another conveyor passes through the common passage, has a first part in the first work environment and a second part in the second work environment, and is predisposed so that the first part can receive the containers and convey them through the common passage at a filling station and a closing station.