Guidelines for Maintenance and Management of Aseptic Rooms

Sterile Room是进行微生物实验、生物制品生产等高要求操作的重要场所，为了Ensure其High-EfficiencyOperation及无菌环境的Maintenance，特制定Sterile RoomMaintenance与管理指南。以下是具体建议：

1、 Basic requirements for sterile rooms

1. Location selection: The sterile room should be located in a place that is less affected by external interference, has low human flow, and is far away from high pollution areas.
2. Space layout: The sterile room should be equipped with buffer rooms and sterile operation areas, both of which should have clear partitions.

2、 Daily maintenance

1. Cleaning and disinfection:
a. Regularly conduct comprehensive cleaning of the sterile room, including walls, floors, workstations, etc.
b. Use appropriate disinfectants to disinfect workstations, laboratory equipment, etc., reducing the possibility of microbial contamination.
c. Necessary cleaning and disinfection work should be carried out before and after daily use.
2. Air purification: Regularly turn on the air purification system to ensure the air quality in the sterile room.
3. Equipment maintenance: Regularly inspect and maintain the equipment in the sterile room, such as air purifiers and disinfection devices, to ensure their normal operation.

3、 Personnel management

1. Personnel entry and exit: Strictly control the entry and exit of personnel in the sterile room, and external personnel must be approved and comply with relevant regulations.
2. Dress code: Personnel entering the sterile room must wear specialized work clothes, masks, gloves, and other protective equipment.
3. Operating standards: Operators must strictly follow sterile operating procedures to avoid cross contamination.

4、 Item management

1. Entry and exit of items: Items entering the sterile room must undergo strict inspection to ensure they are free from contamination before entering.
2. Storage of items: Items should be classified and stored according to requirements to avoid mixing and cross contamination.
3. Waste disposal: Waste must be treated harmlessly or stored in dedicated containers according to regulations.

5、 Regular inspection and evaluation

1. Environmental monitoring: Regularly monitor the environment of the sterile room, such as air cleanliness, surface microbial contamination, etc.
2. Equipment testing: Regularly conduct performance testing and evaluation of sterile room equipment to ensure its normal operation.
3. Evaluation and improvement: Based on the inspection results, evaluate the management effectiveness of the sterile room, propose improvement measures, and implement them.

6、 Emergency response measures

If a pollution accident or equipment failure occurs, the experiment should be immediately stopped and emergency measures should be taken for handling.
2. Thoroughly clean and disinfect the pollution source to ensure harmless treatment before leaving.
3. Report the accident situation to superiors in a timely manner and conduct a summary and analysis to avoid similar situations from happening again.

Pass以上六个方面的综合管理和Maintenance，可以EnsureSterile Room的正常Operation和High-Efficiency工作，为微生物实验、生物制品生产等Provide有力的保障。同时，Pass定期的检查与评估，不断改进和优化管理措施，EnsureSterile Room始终处于良好的Operation状态。