How Many Types of Clean Room in Pharmaceutical Industry

2023-05-26

The pharmaceutical industry has a high clean requirement for the production plant. In the current pharmaceutical industry, each manufacturer will design its clean room in reference to the national standard, which in the process layout, personnel purification, material purification, equipment and other aspects have strict provisions.

According to the ISO standard, the clean room is categorized into nine classes, class1 to class 9. As the class number decreases, the number of particles in the air decreases. It has to be said only class 5 to class 8 for 0.5 µm and 5.0 µm are applicable in pharmaceutical industry.

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Particles and microorganisms are mainly controlled in the pharmaceutical industry clean room and clean area. In addition, provisions should also be made on the ambient temperature, humidity, pressure difference, illumination, noise, etc. The air cleanliness of the pharmaceutical industry clean workshop should be in accordance with GMP grade, which is stipulated as A, B, C, D four grades.

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Regardless of the standard of clean rooms classification , the following requirements are important：

1. Cleanliness: There are important indicators in GMP, namely air cleanliness level. At the same time, WHO (World Health Organization) and EU(European Union) have different requirements for cleanliness level. Air cleanliness level is the core index of evaluating air clean environment.

2. Ventilation rate: The number of air changes in the general air conditioning system is only 8 to 10 times per hour, while the number of air changes in the industrial clean room is 12 times at the lowest level, and hundreds of times at the highest level. So on the basis of accurate positioning of cleanliness, it is necessary to ensure sufficient ventilation times, otherwise the operation result is not up to standard.

3. Static pressure difference: The static pressure difference between different levels of clean room and non-clean room can not be less than 5Pa, between clean room and outdoor can not be less than 10Pa, as well as a series of requirements. The airflow pattern of clean room is the key factor to ensure the cleanliness level.

4. Temperature and humidity: External factors, such as temperature and humidity, can cause much damage to products, such as food, electronics. Therefore, the design of the these production workshop must meet the requirements of GMP about temperature and humidity.

Suzhou Pharma Machinery Co.,Ltd.

2023/05/26

Spencer