Containment clean room for special agents
At a pharmaceutical manufacturer, we have decided to conduct experiments using special agents that cannot be allowed to disperse or leak, necessitating the establishment of a controlled working environment. The working environment must be designed as a sealed structure, maintaining the entire space at negative pressure (a state lower than atmospheric pressure) at all times to prevent the dispersion of the agents. Since we are handling pharmaceuticals, it is essential to ensure cleanliness not only from the perspective of particles but also in terms of microbial counts and mold, which is referred to as biological cleanliness. Issues: 1. Measures are needed to prevent the agents inside the cleanroom from dispersing into the surrounding area. 2. Antimicrobial measures are necessary. 3. We want to operate in a high-cleanliness environment (Class 100). 4. As a double safety measure, we must capture the agents during exhaust.
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basic information
Stainless steel suitable for pharmaceutical lines was selected for the clean room panel material, minimizing seams to achieve high airtightness along with antibacterial and mold-resistant properties. Sterilization lamps are 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 clean room requires high cleanliness, but only a specific working space needs Class 100 cleanliness, the clean room 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 supply air side is designed to be controlled by an inverter, allowing for constant management of appropriate negative pressure. 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 outflow or leakage. After construction, we carry out the necessary validation and sanitation consistently.
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