Air conditioning purification system operation management requirements

1. Basic principles of air purification

Use filtration and other clean technologies to remove particles in the clean room and in the air entering the clean room.

(Figure 1: Clean room air conditioning purification system)

2. Classification of clean rooms

Clean rooms can be industrial clean rooms (with inanimate particles as the control object) and biological clean rooms (with living particles as the control object) according to their use; they can be divided into unidirectional clean rooms, non-unidirectional clean rooms (turbulent clean rooms), turbulent clean rooms, and mixed Clean Rooms according to airflow patterns. According to the cleanliness level, they can be divided into 1-9 levels ("Cleanroom design Specifications") or 300,000, 100,000, 10,000, and 100 levels ("Good Manufacturing Practice for Pharmaceuticals"). The company's clean rooms are all turbulent clean rooms (the laminar Clean bench in the bacteria inspection room is unidirectional). There are 300,000, 100,000, 10,000, and 100 levels.

3. Process parameters of clean rooms

Mainly the following aspects:

Number of dust particles, number of bacteria, pressure difference, temperature, humidity, illumination, noise, and ventilation times.

3.1 Process parameter table

3.2 The pressure difference between the clean room and the non-clean room should be greater than 10pa, and the pressure difference between adjacent rooms of different clean levels should be greater than 5pa. Rooms with large dust and moisture production should maintain a relative negative pressure.

4. Basic composition and characteristics of the purification air conditioning system

The air purification technology used by GMP consists of two parts: air conditioning purification Equipment for treating air, a pipeline system for conveying air, and a clean environment for production, a clean room.

Its basic process is: Clean air is sent into the room from the air supply port, and the dust bacteria generated in the room are diluted by the clean air and forced to enter the return air duct of the system from the return air port (the air in some rooms is still not up to the requirements after dust removal and dehumidification treatment), and is mixed with the filtered fresh air introduced from the outside in the mixing section of the air conditioning equipment, and then sent into the room after being processed by the air conditioner.

The indoor air is circulated repeatedly in this way, and the pollution can be controlled at a considerable level for a considerable period of time. It aims to control particles and form a multifunctional relatively closed integrated whole. Its quality is jointly determined by design, construction, and operation management.

5. Purification system operation management

5.1 According to different systems, operating procedures, cleaning procedures, inspection procedures, and disinfection procedures shall be formulated respectively. Daily maintenance operations can be incorporated into the operation records.

5.2 According to the requirements of the verified self-cleaning time, the air conditioning purification system should be turned on at least 30 minutes before the start of production or work, and can be turned off only after the site is cleared and the humidity in the clean area meets the standard at least 30 minutes later.

5.3 Check the pressure difference on both sides of the primary and medium-efficiency filter bags regularly. When the pressure difference between the primary and medium-efficiency bags increases slowly compared with the initial pressure, it is due to the blockage of dust in the air. It should be cleaned regularly. When it increases suddenly, it may be that the air supply valve or fire damper is closed, the pressure difference in the clean room cannot be guaranteed, and the Air volume is obviously reduced. When the pressure difference suddenly decreases, it may be that the return air valve and return air fire damper, the fresh air valve is closed, or the filter bag is damaged or detached.

(Figure 2: Cleanroom humidity management)

5.4 When the temperature in the clean room exceeds the normal range, the steam valve opening degree can be increased when it is low, and the steam valve opening degree can be reduced when it is high, or the chilled water supply can be increased.

5.5 When the humidity exceeds the normal range, the humidification valve opening can be increased when it is low, or the chilled water supply can be reduced (closed), and the steam valve opening can be reduced. When it is high, the humidification valve opening can be reduced (closed). If it does not meet the requirements, the chilled water supply can be increased and the steam valve opening can be increased.

5.6 The pressure difference in the clean room decreases: when it decreases slowly, it may be due to the blockage of dust in the primary and medium-efficiency filter bags. When it decreases sharply, the fresh air valve, return air valve, air supply valve, fire damper, etc. are abnormally closed or deviate from the normal range. It is also possible that the medium-efficiency bag drops and is damaged in large quantities, and it has not been discovered and has been running for a long time, causing the high-efficiency filter to be blocked.

5.7 When other abnormal conditions are found and cannot be analyzed and resolved, they should be reported to the Enterprise Management Department for joint analysis and resolution with the Production Technology Department and the Quality Department.