Modular, self-contained, mobile clean room
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Solution Overview
Problem
Existing mobile modular plants for biotechnological production lack integrated systems for sterile environments, efficient power supply, and flexible deployment options, making them inefficient and cumbersome for pharmaceutical manufacturing and medical treatment applications.
Innovation Solution
A modular, self-contained cleanroom system with integrated air handling, redundant power sources, fire suppression, and IT systems, allowing for rapid deployment and validation, and enabling connection to external utilities without requiring facility integration, along with external maintenance capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If mobile modular plants are used for biotechnological production, then mobility and flexibility are improved, but integration of sterile environments, power supply, and support systems becomes insufficient
Solution Approach 1:
The system is divided into separate functional modules: a cleanroom module for sterile operations, a mechanical system room module for support equipment, and corridor connector modules for linkage. Each module can be independently transported, assembled, and configured based on specific application requirements, maintaining mobility while integrating complex functions through modular architecture.
Solution Approach 2:
Multiple previously separate systems (cleanroom environment control, power supply with redundant sources, fire suppression, IT systems, and mechanical support) are merged into an integrated modular plant system where components communicate and coordinate through standardized interfaces, reducing overall system complexity while maintaining comprehensive functionality.
2Reliability
If traditional facility integration is required for utility connections, then system reliability is improved, but deployment time and complexity increase
Solution Approach 1:
Utility connections (power, water, HVAC, fire suppression) are pre-integrated and pre-tested within each modular unit during manufacturing. The modules arrive at the deployment site ready-to-connect with pre-configured interfaces, eliminating the need for complex on-site integration work while maintaining reliable system performance through factory-controlled quality assurance.
Solution Approach 2:
Each modular unit is self-contained with internal redundancy (dual power sources, integrated fire suppression, autonomous HVAC control) that allows the module to operate independently or in coordination with other modules without requiring constant external facility support, reducing deployment complexity while ensuring continuous reliable operation.
3Manufacturing precision
If cleanrooms require extensive validation and integration testing, then regulatory compliance is improved, but setup time and cost increase
Solution Approach 1:
The cleanroom system is segmented into standardized modular units with pre-defined validation protocols for each module type. This segmentation allows for modular validation where each unit can be validated independently according to regulatory standards (GMP, ISO), reducing overall validation time compared to validating a custom-integrated facility while maintaining full compliance through documented modular validation procedures.
4Adaptability or versatility
If mobile modular plants lack integrated support systems, then mobility is improved, but operational efficiency and reliability deteriorate
Solution Approach 1:
The modular plant incorporates universal multi-functional support systems that serve multiple purposes: the mechanical system room provides HVAC support, power distribution, and equipment housing; corridor connectors enable both physical linkage and utility transmission; and the integrated IT system provides monitoring, control, and data management across all modules. This multi-functionality maintains mobility while achieving high operational efficiency through coordinated system integration.
Data Source
AI summary
Biosafety units, methods of making and sealing the same are disclosed herein. The present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.


