A. Definition and Standards of Class C Bioengineering Cleanroom
1. Definition Class C bioengineering cleanroom refers to a clean level in the field of bioengineering, divided according to indicators such as air cleanliness, air pressure, air volume, temperature and humidity, noise, and microbial content. It is mainly used for the initial treatment of clean operation areas with lower importance in the production of sterile drugs, such as cell culture and genetic testing.
2. Standard air cleanliness: Class C cleanrooms are also called Class 10,000 cleanrooms. Their cleanliness level is relatively low, allowing the number of particles greater than or equal to 0.5μm per cubic meter of air to reach 352,000 (static) or 3,520,000 (dynamic).
Temperature and humidity control: Constant temperature and humidity need to be maintained to meet the specific requirements of bioengineering experiments or production. Microbial control: Take effective measures to control the growth and spread of microorganisms to ensure the sterility of the production environment.
B. Design and construction of Class C bioengineering cleanroom
1. Layout design The layout of the production area should conform to the process flow, be compact and reasonable, reduce the detours and round trips in the production process, so as to facilitate the rapid transfer of materials and reduce the risk of cross contamination. The necessary process equipment and auxiliary facilities should be set up in the workshop, such as temporary storage room for raw and auxiliary materials, weighing room, preparation room, etc., and ensure that these facilities are effectively isolated from the operation area.
2. The air purification system adopts high-efficiency filters, positive pressure control, air circulation and other technical means to ensure that the air cleanliness in the workshop meets the Class C standard. Regularly maintain and service the air purification system to ensure its normal operation and efficient filtering effect. 3. Temperature and humidity control system Use appropriate air conditioning equipment and humidity control system, combined with temperature and humidity sensors and adjustment devices, to monitor and adjust the temperature and humidity in the workshop in real time. Ensure that the temperature and humidity are controlled within the appropriate range to meet the specific requirements of bioengineering experiments or production.
C. Operation and maintenance of Class C bioengineering purification workshop
1. Daily operation management Establish strict operation management system and operating procedures to ensure the normal operation of various equipment and facilities in the workshop. Clean and disinfect the workshop regularly to keep the environment clean and hygienic.
2. Equipment maintenance Establish a sound equipment maintenance system and regularly inspect, maintain and maintain the equipment. Timely discover and eliminate equipment failure hazards to ensure that the equipment is in good operating condition.
3. Personnel management Strictly control the number of people entering and leaving the workshop and identity authentication to ensure that only trained and authorized personnel can enter. Staff must wear protective clothing and protective equipment that meet the requirements to reduce pollution to the production environment.
D. Challenges and solutions for Class C bioengineering cleanrooms
1. Challenges of microbial control: The growth of microorganisms such as bacteria and mold may affect product quality and employee health. Solution: Strengthen the disinfection and cleaning of the workshop, regularly test the air and surfaces in the workshop, and take effective disinfection measures such as ultraviolet disinfection and air filtration.
2. Challenges of improper temperature and humidity control: Improper temperature and humidity control may cause product failure or equipment damage. Solution: Use precise temperature and humidity control systems and sensors to monitor and adjust the temperature and humidity in the workshop in real time to ensure that they are within the appropriate range.
3. Challenges of equipment failure risks: Equipment failure may cause production interruptions and quality problems. Solution: Establish a sound equipment maintenance system and strictly implement it to promptly discover and eliminate potential faults; at the same time, prepare spare equipment to deal with emergencies. In summary, Class C bioengineering cleanrooms need to take a series of effective measures in design and construction, operation and maintenance, and response to challenges to ensure that key indicators such as cleanliness, temperature and humidity control, and microbial control meet standard requirements, thereby ensuring the smooth progress of bioengineering experiments or production and the stability and reliability of product quality.
