Modular, self-contained, mobile clean room
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current mobile modular plants for biotechnological product development and pharmaceutical manufacturing lack integrated, self-contained, and easily deployable cleanroom solutions with advanced sterilization and automation capabilities, which are essential for ensuring compliance with regulatory standards and efficient product transition between different sterilization protocols.
Innovation Solution
A modular, self-contained cleanroom system with integrated air handling, redundant power sources, a gas fire suppression system, and advanced sterilization methods such as vapor hydrogen peroxide cleaning, allowing for rapid deployment and reconfiguration, and compliance with cGMP guidelines, along with a unified information technology system for monitoring and control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If mobile modular plants are used for biotechnological product development, then flexibility and mobility are improved, but integration of sterilization and automation capabilities is insufficient
Solution Approach 1:
The patent combines multiple previously separate functions (cleanroom environment control, sterilization systems, automation equipment, and monitoring systems) into a single integrated mobile modular plant. This merging allows the system to maintain mobility while achieving comprehensive integration of sterilization and automation capabilities, resolving the contradiction between adaptability and device complexity.
Solution Approach 2:
The mobile modular plant is designed as a universal platform that can perform multiple functions including manufacturing, sterilization, quality control, and data monitoring within a single mobile unit. This multi-functionality enables the system to adapt to different biotechnological product development needs while maintaining integrated capabilities, thus improving versatility without proportionally increasing complexity.
2Reliability
If traditional cleanroom solutions are used, then regulatory compliance is achieved, but rapid deployment and reconfiguration capability is limited
Solution Approach 1:
The cleanroom system is divided into modular segments that can be independently assembled, deployed, and reconfigured. This segmentation allows the system to maintain regulatory compliance through standardized modular components while enabling rapid deployment by simply assembling pre-certified modules, thus reducing deployment time without sacrificing reliability.
Solution Approach 2:
The system incorporates dynamic reconfiguration capabilities where modular cleanroom units can be quickly assembled, disassembled, and repositioned while maintaining their certified cleanroom status. This dynamic design allows the system to adapt to different locations and requirements rapidly while preserving regulatory compliance through maintained environmental controls and monitoring.
3Reliability
If advanced sterilization methods are implemented, then sterilization effectiveness is improved, but system complexity and operational difficulty increase
Solution Approach 1:
The sterilization system incorporates automated self-monitoring and self-regulation capabilities where sensors detect sterilization progress and automatically adjust parameters to achieve effective sterilization. This self-service approach maintains high sterilization effectiveness while reducing operational difficulty by eliminating the need for manual monitoring and adjustment of complex sterilization parameters.
Solution Approach 2:
The system implements feedback mechanisms where sensors continuously monitor sterilization process parameters and outcomes, automatically adjusting the sterilization process to maintain effectiveness. This closed-loop control simplifies operation by allowing the system to self-optimize sterilization effectiveness without requiring complex manual intervention, thus improving reliability while maintaining ease of operation.
4Productivity
If modular units are designed to be self-contained, then deployment speed is improved, but integration with host facility utilities becomes complex
Solution Approach 1:
The self-contained modular units are designed with universal interfaces and standardized utility connections that can interface with various host facility systems. This universality allows the modules to be quickly deployed as standalone units while also enabling straightforward integration with host facility utilities when needed, thus improving deployment speed without creating complex integration challenges.
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
Enables rapid deployment and reconfiguration of pharmaceutical manufacturing facilities that meet cGMP standards, ensuring effective sterilization and compliance, and allows for efficient product transition between different protocols, enhancing operational efficiency and safety.
Implementation Method 1
one or more vapor hydrogen peroxide cleaning systems
Implementation Method 2
vapor hydrogen peroxide cleaning systems
Implementation Method 3
one or more gas-based fire suppression systems
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.