Clean Room Navigation Layout for Rapid Pharma Reconfiguration

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Solution Overview

Problem

Conventional pharmaceutical production facilities are inflexible and costly to adapt to new products, requiring extensive planning and personnel training, which can lead to manufacturing errors and safety risks, especially when switching between products quickly or producing short-run items.

Innovation Solution

A method using a navigation system to select and determine specific devices and materials needed for a pharmaceutical product, assigning their locations in a clean room, and providing manufacturing instructions, allowing for rapid reconfiguration and efficient use of space, reducing human error and costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional fixed production facilities are used, then quality and safety standards are maintained, but flexibility to manufacture new products is reduced

Engineering Contradiction:
Improveflexibility to manufacture new productsVSAvoidquality and safety standards
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent implements dynamic reconfigurability of clean rooms through a navigation system that guides the rapid relocation and repositioning of production devices and materials. The system allows the clean room environment to dynamically adapt to different product manufacturing requirements while maintaining controlled conditions through structured reconfiguration processes that preserve quality and safety standards.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The production facility is segmented into movable modular components that can be independently repositioned. The navigation system divides the reconfiguration task into discrete steps, guiding operators to move specific devices and materials to predetermined locations, enabling flexible product switching while maintaining systematic control over quality and safety parameters.

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If production facilities are made flexible for short-term products, then adaptability improves, but human error and manufacturing mistakes increase

Engineering Contradiction:
Improveadaptability for short-term productsVSAvoidmanufacturing errors and human error
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The navigation system provides real-time feedback to operators during the reconfiguration process, displaying step-by-step instructions and confirming correct device placement. This feedback mechanism reduces human error by guiding operators through standardized procedures, ensuring that even during rapid reconfiguration for short-term products, manufacturing accuracy and quality standards are maintained.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables self-guided reconfiguration through automated navigation instructions that lead operators through the setup process without requiring extensive external supervision or training. The standardized procedures reduce reliance on highly trained personnel while minimizing human error through systematic, error-resistant workflows.

Inventive Principle:
Principle #25Self-service

3Loss of time

If conventional fixed devices are installed, then quality control is maintained, but reconfiguration effort and time increase

Engineering Contradiction:
Improvereconfiguration timeVSAvoidreconfiguration effort
Core Design Contradiction:
Loss of timeVSEase of manufacture

Solution Approach 1:

The navigation system employs preliminary action by pre-calculating and storing optimal device positions and reconfiguration sequences for different product manufacturing scenarios. When a product change is required, the system retrieves pre-planned instructions and guides operators through the reconfiguration process, significantly reducing both reconfiguration time and effort compared to ad-hoc planning.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system manages reconfiguration by changing operational parameters rather than physical infrastructure. The navigation system adjusts device positions, material locations, and process parameters through standardized procedures, enabling rapid transitions between products without requiring major structural modifications or extensive manual reconfiguration effort.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS10955812B2Navigation system for clean rooms
Publication Date: 2021.03.23 SARTORIUS STEDIM BIOTECH GMBH
  • US10955812B2 patent drawing

AI summary

A method for configuring a clean room (2) for the manufacture of pharmaceutical products and the manufacture of pharmaceutical products includes the steps: selecting a pharmaceutical product for the manufacture in the clean room (2); determining one or a plurality of specific devices (16) and/or one or a plurality of specific materials (18) for the manufacture of the selected pharmaceutical product; and assigning locations for the particular, respectively specific devices (16) and/or specific materials (18) in the clean room (2) and, that is, by using a navigation system (4). The navigation system (4) issues at least one notification (6, 8, 10, 12, 14) associated with a location in the clean room (2) indicating where the specific device (16) and/or the specific material (18) for the manufacture of the selected pharmaceutical product is/are to be placed.