Mobile Cleanroom Redundancy for Air and Power Fail-Over
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Solution Overview
Problem
Current mobile modular plants for biotechnological product development and pharmaceutical manufacturing lack redundancy in air and power supply systems, leading to potential disruptions in cleanroom operations, and require specialized personnel for maintenance and validation, limiting their flexibility and deployment.
Innovation Solution
A modular, self-contained cleanroom system with redundant air handling units and power busses providing Class 100,000 air purity, instantaneous fail-over capabilities, and pre-validation for pharmaceutical manufacturing, along with a unitary information technology system and universal connectors for easy integration and maintenance, allowing for flexible deployment and operation without specialized personnel.
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 redundancy in air and power supply systems is lost
Solution Approach 1:
The cleanroom system is divided into modular units that can be independently configured and deployed. Each module contains its own air handling and power systems, allowing flexible arrangement while maintaining redundant capabilities within each self-contained unit.
Solution Approach 2:
The system incorporates pre-configured redundant air handling units and power supply systems that are prepared in advance. These backup systems remain standby-ready to immediately take over if the primary systems fail, ensuring continuous operation without requiring complex real-time switching mechanisms.
2Adaptability or versatility
If mobile modular plants are used for pharmaceutical manufacturing, then deployment flexibility is improved, but specialized personnel requirements increase
Solution Approach 1:
The modular cleanroom system incorporates self-diagnostic capabilities and automated monitoring systems that can detect and report issues without requiring specialized personnel. The system performs self-checks on air purity, pressure differentials, and equipment status, reducing the need for expert intervention during routine operations.
Solution Approach 2:
The system uses universal connectors and standardized interfaces for electrical, water, gas, and HVAC connections that can be easily attached and detached without specialized tools or knowledge. This allows non-specialized personnel to perform basic maintenance and reconfiguration tasks.
3Loss of time
If validation is performed on-site for pharmaceutical manufacturing, then deployment time is reduced, but validation reliability may be compromised
Solution Approach 1:
The modular cleanroom units are pre-validated in controlled manufacturing environments before deployment. All critical systems including air handling, filtration, pressure control, and monitoring equipment are validated prior to shipment, allowing for rapid on-site deployment without compromising validation reliability. The pre-validation documentation travels with the module and can be supplemented with minimal on-site verification.
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
Ensures continuous air and power supply to the cleanroom with fail-over systems, reduces maintenance needs by allowing external servicing, and facilitates rapid deployment and validation, enhancing operational reliability and flexibility in pharmaceutical manufacturing and patient care settings.
Implementation Method 1
at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity
Implementation Method 2
wherein a pressure gradient is formed between the cleanroom and the exterior of the structure
Implementation Method 3
the air flow within the cleanroom is laminar
Implementation Method 4
the air handling unit and power busses have instantaneous fail-over during operation of the cleanroom without loss of air or power to the cleanroom
Data Source
AI summary
Biosafety units, methods of making, and sealing the same are disclosed herein. The units comprise at least one controlled air, sealable, sterilizable cleanroom; and a mechanical system room adjacent to the cleanroom comprising: at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the structure; and at least two power supplies that provide redundant power to electrical outlets in the cleanroom, wherein the at least two power supplies are connectable to one or more external power sources and the structure is pre-validatable or validated for pharmaceutical manufacturing.