Clean room is the core of drug production, and its cleaning effect directly affects the quality of drugs. When the clean room environment is polluted, it is difficult to guarantee the quality of drugs. This kind of drugs will delay or aggravate the patient's condition, which will bring great physical harm and adverse social impact. Therefore, for pharmaceutical enterprises, the pollution control of clean rooms must be taken seriously and strictly implemented. This paper discusses the relevant measures of clean room pollution control for reference. In order to effectively control the clean room environment, it is necessary to control the pollution sources that produce particles and microorganisms to the maximum extent. Measures to control pollution can be taken from various aspects, such as the types of pollution and the control of production process. From the production-related objects and people, the production environment, production personnel, production facilities and materials become pollution sources because they carry, pollute, attach or produce particles and microorganisms. This paper will analyze from these three aspects.

1 air conditioning purification system

The whole process control of clean room is essentially a comprehensive control of pollution around two links: controlling dust production and effectively discharging dust. Clean room environment includes clean room structure, wall materials, water system, air conditioning purification system, etc. The verified air conditioning purification system can meet the cleanliness requirements under normal working conditions. There are two kinds of pollution caused by air conditioning purification system: one is the pollution caused by the objective operation of the system, and the other is that the control factors are not up to standard.

1. 1 Pollution caused by objective system operation

This means that after the air conditioning purification system runs, microorganisms may breed due to dust particles and moisture (or high humidity) accumulated in some places. The particle size of microbial metabolites is very small, and it is easy to enter the clean room through the filter, which makes the cleanliness drop rapidly. Single air filtration in pharmaceutical factories can't completely control microorganisms at ordinary times, so the air should be disinfected regularly. Common air disinfection methods include direct ultraviolet irradiation, ozone disinfection, spraying disinfectant, electrostatic adsorption and other technologies. Drug resistance should be considered when using disinfectants, and the combined disinfection method of at least two ways should be adopted. In particular, it should be noted that the disinfection effect of disinfectants is not sustainable and it is easy to cause secondary pollution, while other disinfectants have certain disadvantages. Therefore, in order to avoid dust retention, do not use hoses and soft connectors, and regularly clean the components of the air conditioning system to avoid particles, moisture and local high humidity.

1.2 control factor

GMP has clear requirements for the temperature, humidity, air pressure, light and noise of clean rooms. Air conditioning system affects these indicators, from positive pressure, air exchange times, suspended particles control to meet cleanliness.

1.2. 1 The positive pressure of clean room and adjacent room is insufficient at the same sampling area within two meters from the door. If the test exceeds the standard when opening the door, it can be judged that the positive pressure in the clean room and adjacent room is insufficient after closing the door for 20 minutes. If the positive pressure value is not up to standard, the outside atmosphere will flow backwards, bringing a lot of dust and bacteria, seriously damaging the cleanliness. At this time, it can be solved by increasing the positive pressure until there is enough outflow airflow at the moment of opening the door to prevent the invasion of pollutants. First of all, we can consider increasing the fresh air volume, but we may need to increase the fresh air units, which is not a small one-time investment. In addition, the more economical and applicable method is to adjust the resistance of filters at all levels, and reduce the resistance of filters as much as possible while ensuring the filtering effect. In addition, the primary and secondary filters should be replaced in time, and the condenser and cold and hot water coil I should be cleaned and maintained in time.

1.2.2 The number of air changes in the clean room is unreasonable. No matter the dilution release effect in turbulence or the displacement effect in single-phase flow, all parameters of the clean room need to be controlled and realized by the amount of clean air, so the air exchange times of the clean room should not be too low. If there are too many air changes in the clean room, it will increase the operating cost and may not necessarily improve the level of the clean room accordingly. The number of air changes in a clean room depends on the calculation of indoor heat balance. Generally, the L-level air exchange rate is above 25 times per hour, and the L-level air exchange rate is above 15 times per hour. The air supply volume of the clean room should take the following three maximum values: the air supply volume to ensure the air cleanliness level; According to the calculation of heat and humidity load, the air supply volume is determined; The amount of fresh air supplied to the clean room. Among them, the fresh air volume should take the maximum of the following two items: the sum of the compensated indoor exhaust air volume and the fresh air volume needed to maintain the indoor positive pressure value; Keep the amount of fresh air provided to the clean room per person per hour not less than 40 cubic meters J.

People are an important source of clean room pollution.

The metabolism of the human body will produce pollutants, and the human body will carry pollutants. When people are active in the clean room, they will produce and emit a lot of pollutants. According to the analysis of the test results, workers account for about 80% of the pollution in the clean room, and the dust entering and leaving the clean room has obviously increased. When people are exercising, the cleanliness is obviously worse, which proves that people are the main cause of clean room pollution. As the biggest pollution source and the most important medium in drug production, people are always in direct or indirect contact with drugs, which affects the quality of drugs. This influence comes from two aspects, one is the original physical condition of the personnel. The second is personal hygiene habits. Therefore, the management and supervision of human health should start from the following aspects.

2. 1 Necessity of establishing health records When recruiting employees, pharmaceutical companies have already had a general understanding of the health status of employees. Pharmaceutical companies also need to formulate physical examination rules and conduct regular physical examinations for employees. Zaijie