Vacuum Chamber Sealing for Aseptic Bubble-Free Pharma Containers
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Solution Overview
Problem
Existing controlled environment enclosures require human intervention via gloves, which pose a risk of puncture, and struggle with accurately and aseptically dispensing and vacuum sealing pharmaceutical fluids into containers, particularly syringes or cartridges, while preventing air bubbles.
Innovation Solution
A method and apparatus using a sterilizable chamber with a closure nest restraining element to align and vacuum-tight seal pharmaceutical containers, employing a mechanical system to engage closures under vacuum conditions, ensuring aseptic conditions and preventing vertical motion of containers during sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated equipment is used in controlled environment enclosures, then productivity is improved, but device complexity increases and human intervention via gloves is still required
Solution Approach 1:
The system is divided into two separate sterile enclosures: a first enclosure for filling operations and a second enclosure for sealing operations. This segmentation allows each enclosure to be optimized for its specific function, reducing the complexity of individual devices while maintaining high productivity through continuous operation across both enclosures.
Solution Approach 2:
Asterile transfer mechanism acts as an intermediary between the filling and sealing enclosures, enabling automated transfer of filled containers without requiring human intervention. This intermediary system maintains sterility while eliminating the need for gloves in the sealing process.
2Ease of operation
If gloves are used for human intervention, then ease of operation is improved, but reliability deteriorates due to puncture risk
Solution Approach 1:
The sealing operation is extracted from the filling enclosure and performed in a separate sterile enclosure, eliminating the need for human operators to wear gloves during the sealing process. This extraction removes the puncture risk entirely while maintaining ease of operation through automated mechanisms.
Solution Approach 2:
The system uses automated mechanisms within the sterile enclosure to perform sealing operations without human intervention. The equipment serves itself by automatically positioning, sealing, and ejecting finished products, eliminating the need for gloved operators.
3Manufacturing precision
If vacuum sealing is performed to prevent air bubbles, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The system changes the pressure parameter by creating a vacuum environment in the sealing enclosure. This parameter change causes air bubbles to rise and escape from the containers during sealing, achieving high manufacturing precision without requiring complex bubble detection or removal systems.
4Reliability
If sterile enclosures are used to maintain aseptic conditions, then purity is improved, but device complexity increases
Solution Approach 1:
The sterile environment is segmented into two separate enclosures, each performing a specific function (filling and sealing). This segmentation reduces the complexity of maintaining sterility compared to a single large enclosure, as each smaller enclosure can be independently sterilized and monitored.
Solution Approach 2:
A sterile transfer mechanism serves as an intermediary between the two enclosures, maintaining aseptic conditions during material transfer. This intermediary system allows the enclosures to be independently managed while ensuring continuous sterile operation.
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
The system achieves aseptic and vacuum-tight sealing of pharmaceutical fluids into containers with minimal human intervention, reducing the risk of contamination and ensuring no trapped air bubbles, meeting stringent leak rate standards.
Implementation Method 1
reducing an air pressure in the chamber to a predetermined level to create a vacuum condition
Implementation Method 2
increasing the air pressure in the chamber to force the plurality of closures deeper into the corresponding plurality of containers
Data Source
AI summary
The present invention involves a sterilizable vacuum chamber that provides for sealing a pharmaceutical fluid into a plurality of containers, the chamber comprising a vertically movable container nest holder for holding a container nest bearing a plurality of pharmaceutical containers filled with a pharmaceutical fluid, a container closure nest holder for holding a closure nest bearing a plurality of corresponding container closures and for locating a closure vertically above each corresponding container, a ram for vertically moving the container nests to engage the containers with corresponding closures, and an elastically deformable closure nest restraining element disposed on an opposing side of the closure nest from the container nest. A method is provided for sealing the pharmaceutical fluid into the containers. The method comprises the closure nest restraining element acting on the closure nest to oppose any vertical upward motion of any of the plurality of containers after the engaging of the containers with the closures.