Nested Environmental Containment Enclosures for Bioreactor Sterility
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Solution Overview
Problem
Traditional bioreactors and manufacturing systems lack effective environmental containment, leading to contamination and exposure risks during cell culture and chemical/pharmaceutical processes, especially when handling hazardous or infectious materials.
Innovation Solution
The development of a multi-level environmental containment system with complementary shaped enclosures that surround vessels, creating sealed spaces with independent control to maintain sterile, aseptic, or particle-free environments, and incorporating ventilation systems or treatment systems to prevent contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional bioreactors and manufacturing systems are used without environmental containment, then device complexity is reduced and ease of operation is improved, but contamination and exposure risks increase significantly
Solution Approach 1:
The patent implements nested containment enclosures where an inner enclosure surrounds the vessel and an outer enclosure surrounds the inner enclosure. This nested structure creates multiple containment layers that work together to maintain sterile conditions while managing complexity through modular organization of protective barriers.
Solution Approach 2:
The containment system is divided into separate functional segments: the inner enclosure for direct vessel protection, the outer enclosure for environmental shielding, and the gap space for independent environmental control. This segmentation allows each component to be optimized independently while contributing to overall system reliability.
2Object-affected harmful factors
If a sealed containment enclosure is implemented, then contamination protection is improved, but access to the vessel and ease of operation deteriorate
Solution Approach 1:
The gap space between the inner and outer enclosures serves as an intermediary zone that allows environmental control and monitoring without requiring direct access to the vessel or inner enclosure. This intermediate space can be equipped with ports, sensors, and control mechanisms that maintain the sealed barrier while enabling operational access.
Solution Approach 2:
The patent introduces a spatial dimension (the gap between enclosures) that provides access pathways and control interfaces without compromising the sealed barrier. By utilizing the intermediate space, the system maintains vertical and horizontal separation while allowing operational interactions through controlled ports and openings in the enclosures.
3Reliability
If an environmental treatment system is added to maintain aseptic environment, then sterility and particle-free conditions are improved, but device complexity and energy consumption increase
Solution Approach 1:
The environmental treatment system operates continuously within the gap space to maintain constant aseptic conditions. This continuous action prevents contamination before it occurs, eliminating the need for extensive post-contamination cleaning or remediation, thereby reducing overall energy consumption despite the continuous operation of treatment mechanisms.
Solution Approach 2:
The gap space environment is designed to be self-regulating through integrated treatment systems that automatically maintain aseptic conditions without requiring external intervention. The system monitors and adjusts environmental parameters autonomously, reducing the energy burden of manual control and optimization.
Data Source
AI summary
Environmental containment systems, and in certain embodiments, systems and methods involving vessels and unit operations or components of cell culture, cell containment, bioreactor, chemical manufacturing, or pharmaceutical manufacturing systems provided with environmental containment are provided. Certain vessels, unit operations, devices, and components may be used to perform all or part of biological, chemical, and/or pharmaceutical manufacturing processes therein. In some embodiments, an environmental containment system includes a multi-level containment apparatus. For instance, a first substantially closed environmental containment enclosure may be contained within a second substantially closed environmental containment enclosure; the first and second enclosures may be contained in a third substantially closed environmental containment enclosure, etc. Each of the environments within the substantially closed environmental containment enclosures may be controlled independently, and leakage of any materials from an inner system may be contained by an outer system.