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What are the key design considerations for a clean room plant layout?

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A clean room plant layout is a specialized design that aims to minimize the contamination of products, processes, and equipment by airborne particles, microorganisms, and other sources of contamination. Clean rooms are essential for industries that require high standards of quality, safety, and hygiene, such as pharmaceuticals, biotechnology, electronics, and aerospace. In this article, you will learn about the key design considerations for a clean room plant layout, such as the classification of clean rooms, the selection of materials and equipment, the configuration of airflow and ventilation, the integration of utilities and services, and the compliance with regulations and standards.

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Manoj Silva

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1 Classification of clean rooms

The first step in designing a clean room plant layout is to determine the level of cleanliness required for the specific product or process. Clean rooms are classified according to the number and size of particles allowed per cubic meter of air, based on the ISO 14644-1 standard. The standard defines nine classes of clean rooms, from ISO 1 (the cleanest) to ISO 9 (the least clean). The classification of the clean room affects the design of the layout, as it determines the type and frequency of air filtration, the pressure differential between adjacent zones, the amount of air changes per hour, and the layout of personnel and material flows.

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Manoj Silva

"Driving excellence through continuous improvement." Project Leader| Strategist| QHSE Consultant|
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Clean room layout design should also align with industry-specific regulatory requirements and standards. Compliance with regulations ensures product quality, safety, and regulatory approval are obtained without much hassle.

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2 Selection of materials and equipment

The second step in designing a clean room plant layout is to select the materials and equipment that are suitable for the desired level of cleanliness and the specific product or process. The materials and equipment used in a clean room should be resistant to corrosion, abrasion, and chemical exposure, as well as easy to clean and disinfect. They should also have low emission of particles, volatile organic compounds, and electrostatic charges. Some examples of materials and equipment commonly used in clean rooms are stainless steel, epoxy resin, polyvinyl chloride, high-efficiency particulate air filters, laminar flow hoods, and ultraviolet germicidal irradiation lamps.

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Manoj Silva

"Driving excellence through continuous improvement." Project Leader| Strategist| QHSE Consultant|
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Failing to account for personnel movement. This occurs mainly due to a lack of experience or knowledge from people operating clean rooms. When planning clean room operations strict protocols and procedures for personnel movement, including training, gowning requirements, designated entry and exit points, air showers, and airlocks should be introduced. Additionally, continuous monitoring and control of environmental conditions help to minimize the risk of contamination and maintain clean room integrity.

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3 Configuration of airflow and ventilation

The third step in designing a clean room plant layout is to configure the airflow and ventilation system that will provide the required level of cleanliness and maintain the optimal temperature, humidity, and pressure conditions. The airflow and ventilation system should be designed to achieve a uniform and unidirectional flow of filtered air from the ceiling to the floor, or from one wall to the opposite wall, depending on the layout of the clean room. The system should also be designed to prevent cross-contamination between different zones or processes, by creating positive or negative pressure gradients, isolating critical areas, and using airlocks or pass-through chambers.

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Manoj Silva

"Driving excellence through continuous improvement." Project Leader| Strategist| QHSE Consultant|
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Incorrect sizing of the cleanroom and improper airflow configuration lead to many operational problems. A common mistake made during the cleanroom project design is when the airflow patterns are not considered in the operational layout. This results in high-pressure, low-pressure areas inside the clean room, causing contaminants to move around easily. This also results in increased energy bills for pumping air to maintain the desired environment.

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4 Integration of utilities and services

The fourth step in designing a clean room plant layout is to integrate the utilities and services that will support the operation and maintenance of the clean room. The utilities and services include the electrical, water, gas, steam, compressed air, vacuum, and waste disposal systems, as well as the fire protection, security, communication, and monitoring systems. The utilities and services should be integrated in a way that minimizes the interference with the airflow and ventilation system, reduces the risk of leaks or spills, and facilitates the access and repair of the components. The utilities and services should also be designed to meet the specific requirements of the product or process, such as the purity, pressure, flow rate, and temperature of the fluids.

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5 Compliance with regulations and standards

The fifth step in designing a clean room plant layout is to comply with the relevant regulations and standards that govern the design, construction, operation, and validation of clean rooms. The regulations and standards vary depending on the industry, the country, and the product or process. Some examples of regulations and standards that apply to clean rooms are the ISO 14644 series, the EU GMP Annex 1, the US FDA 21 CFR Part 11, and the IEST-RP-CC series. The compliance with the regulations and standards ensures that the clean room plant layout meets the expectations of the customers, the regulators, and the stakeholders, as well as the objectives of the quality, safety, and hygiene.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the key design considerations for a clean room plant layout?

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1 Classification of clean rooms

2 Selection of materials and equipment

3 Configuration of airflow and ventilation

4 Integration of utilities and services

5 Compliance with regulations and standards

6 Here’s what else to consider

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