Clean room environmental control

Clean Room Environmental Control To ensure product quality, safety, and hygiene, pharmaceuticals, food manufacturing, medical devices, and biochemical and bacterial culture require a sterile production environment known as a clean room. In pharmaceutical production, microparticles and microorganisms are the main targets of environmental control within a clean room. The cleanliness level of the room is determined by the number of airborne particles, and the air purification system plays a crucial role in maintaining this standard. For injection production, where the required air cleanliness is 100, vertical or horizontal unidirectional airflow patterns are used, with air velocity greater than 0.25 m/s and 0.35 m/s respectively. When the cleanliness requirement is 10,000 or 100,000, non-unidirectional airflow is applied, with an air change rate of more than 25 times per hour and 15 times per hour, respectively. For 300,000 cleanliness, the air change rate should be at least 12 times per hour. This ensures that dust generated during production is quickly removed, maintaining a controlled and clean environment. Maintaining the correct pressure difference between the clean room and adjacent areas is also essential for ensuring cleanliness. The pressure difference between different clean rooms and between clean and non-clean areas should be greater than 5 Pascals, while the pressure difference between the clean area and the outside should exceed 10 Pascals. The air supply, return, and exhaust systems must be operated in sequence to prevent air backflow and reduce contamination from lower-level dust. Before each production run and after a certain cycle, the number of particles should be tested under static conditions after cleaning to assess the particle content in the clean room. Clean rooms are categorized into biological and non-biological types. Biological clean rooms require continuous operation of the air purification system, while non-biological ones should be turned on at least four hours before use. After cleaning, the environment should be allowed to stabilize for 0.5 to 1 hour before testing with a particle counter. To minimize human contamination, only two people are allowed in the clean room at a time. During injection production, dynamic monitoring of critical points is necessary to control microbial content. The microbial content in the clean room is primarily managed through efficient air purification systems, which can filter out 99.9% to 99.99% of bacteria and dust. Temperature is strictly controlled between 18–26°C, and humidity between 45%–65%, to inhibit bacterial growth. Disinfectants like 75% ethanol or 2‰ Xinjieermei solution are used daily to wipe surfaces, and 3–5% disinfectant is used for floor cleaning. Every three days, a deeper disinfection using 75% ethanol or 2‰ Xinjieermei solution is performed. If mold is present, the room is first sprayed with 5% sodium carbonate, followed by formaldehyde fumigation to eliminate spores and bacteria. Formaldehyde gas sterilization is effective against molds and bacterial spores. The process requires room temperature above 35°C, humidity over 60%, and 10g/m³ of formaldehyde. The fumigation period should last at least 12 hours, and ammonia water is used for neutralization afterward to reduce harm. Ozone is sometimes used alternately to prevent resistance. Human operators are the primary source of contamination in aseptic environments. The number of personnel, their movements, and the type and condition of their protective clothing significantly affect bacterial levels. Strict control over the design, material, cleaning frequency, and sterilization cycle of cleanroom garments, along with limiting the number of operators and regulating their behavior, is essential to maintain a high-purification level. **APB-777 Clean Transfer Window** This device is essential for transferring small items between clean and non-clean areas, reducing the need to open the clean room and minimizing contamination. **Features:** 1. Made of stainless steel, with smooth surfaces and rounded inner corners. 2. Equipped with fans on both sides to provide interconnection and automatic air supply. 3. Lights and UV germicidal lamps operate simultaneously with the fan. 4. Custom options are available upon request. **Technical Specifications:** - Model: APB-557, APB-777 - Cleanliness Level: Class 100 @ ≥0.5μm (US Federal 209E) - Average Air Speed: 0.25–0.45 m/s - Noise Level: ≤62 dB(A) - Power Supply: AC, 220V/50Hz - HEPA Filter Size: 480×460×38mm×1, 680×460×38mm×1 - Working Dimensions: 420×480×400mm, 500×480×500mm - Overall Dimensions: 650×540×850mm, 650×530×850mm [Image: APB-777.JPG] [Image: Shanghai net two-dimensional code.jpg]

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