Modular, self-contained, mobile clean room

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Solution Overview

Problem

Current biosafety and pharmaceutical manufacturing facilities face challenges in maintaining sterile and controlled environments, particularly in mobile and modular settings, where redundancy and fail-over systems for air and power are lacking, and validation for cGMP compliance is complex, making them inefficient for rapid deployment and flexible use.

Innovation Solution

A modular, self-contained cleanroom system with redundant air handling and power systems, connected to a mechanical service room, providing Class 100,000 air purity and instantaneous fail-over capabilities, along with a pre-validatable IT system for monitoring and control, allowing for flexible deployment and validation for pharmaceutical manufacturing without specialized personnel or permits.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If mobile modular plants are used for biotechnological product production, then flexibility and rapid deployment are improved, but reliability and redundancy of air handling and power systems deteriorate

Engineering Contradiction:

ImproveflexibilityVSAvoidredundancy

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The plant is divided into separate mobile modules, each with its own air handling unit and power supply. This segmentation allows each module to operate independently with full redundancy, resolving the contradiction by making the system both flexible (through modular configuration) and reliable (through independent backup systems in each module).

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Each mobile module is equipped with locally integrated redundant air handling and power systems rather than relying on centralized infrastructure. This local quality approach ensures that each module maintains reliability independently while preserving overall system flexibility through modular deployment options.

Inventive Principle:

Principle #3Local quality

2Manufacturing precision

If validation for cGMP compliance is performed on existing facilities, then manufacturing precision and quality control are improved, but time consumption and operational disruption worsen

Engineering Contradiction:

Improvequality controlVSAvoidvalidation time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The mobile modules are pre-validated for cGMP compliance during manufacturing and assembly before deployment. This preliminary validation eliminates the need for time-consuming on-site validation procedures, allowing immediate operational use while ensuring quality control standards are met from day one.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The modules are designed as pre-validated, single-use or limited-use units that can be deployed immediately without requiring extensive validation procedures. After use, they can be replaced rather than re-validated, significantly reducing time loss while maintaining manufacturing precision through factory-controlled validation processes.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 redeployment of sterile manufacturing facilities with continuous operation and minimal disruption, ensuring compliance with cGMP standards and allowing for flexible scaling and maintenance without entering the cleanroom, enhancing energy efficiency and adaptability for various applications.

Implementation Method 1

a pressure gradient is formed between the cleanroom and the exterior of the structure

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

the air flow within the cleanroom is laminar

Methodology Applied

Scientific EffectLaminar flow: Laminar Flow

Implementation Method 3

an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS9765980B2Modular, self-contained, mobile clean room

Publication Date: 2017.09.19 G CON MANUFACTURING INC

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.