[Case Study] Containment Clean Room for Special Chemicals

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last updated：Oct 22, 2020

蒲田工業

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Containment clean room for special agents

At a pharmaceutical manufacturer, we will be conducting experiments using special agents that cannot be allowed to disperse or leak, and we need to improve the working environment. The working environment must be a sealed structure, maintaining the entire space under negative pressure (a state lower than atmospheric pressure) at all times to prevent the dispersion of the agents. Since we are handling pharmaceuticals, in addition to cleanliness from the perspective of particles, cleanliness from the perspective of bacterial counts and mold, known as biological cleanliness, is also required. Issues: 1. Measures are needed to prevent the agents inside the clean room from dispersing into the surrounding area. 2. Antimicrobial measures are necessary. 3. We want to work in a high-cleanliness environment (Class 100). 4. As a double safety measure, we must capture the agents during exhaust.

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The panel material for the cleanroom was selected as stainless steel suitable for pharmaceutical lines, minimizing seams to achieve high airtightness along with antibacterial and mold-resistant properties. Sterilization lamps were also installed in the room, allowing for sterilization of the entire area by irradiating it for a certain period after work is completed. Since not the entire cleanroom requires high cleanliness but only a specific workspace needs Class 100 cleanliness, the cleanroom itself is designed to Class 1000 specifications, with a clean bench (Class 100) installed within it, creating a double structure. This double structure offers advantages in terms of management and cost compared to a structure that maintains the entire space at Class 100. As a measure to prevent scattering, the FFU on the air supply side is designed to be controlled by an inverter to maintain appropriate negative pressure at all times. Additionally, an exhaust box with a built-in HEPA filter is provided on the exhaust side to capture chemicals, ensuring that there is no risk of leakage or outflow. After construction, we provide a consistent process for the necessary validation and sanitation.