A clean room refers to a sealed space where air cleanliness, temperature, humidity, pressure, airflow, noise, vibration, static electricity, and other parameters are controlled as needed. The pharmaceutical industry, electronics industry, chemical industry, and food and cosmetics industry all require clean rooms as places for product production and testing.

For drug production, the GMP validation guidelines stipulate that the refining, drying, and packaging of formulations and active pharmaceutical ingredients, as well as the production of raw materials used in formulations and packaging materials that come into direct contact with drugs, should all be carried out in clean areas. The presence of particles directly affects drug quality and endangers people‘s life safety; Besides particles, microorganisms in the production environment pose a more serious threat to human health; It is precisely for these reasons that pharmaceutical manufacturing companies must simultaneously control the particles and microorganisms in the production environment in their clean rooms. In addition to particles and microorganisms, other control requirements have also been proposed, such as temperature, humidity, pressure difference, noise, illumination, etc.

Verification of cleanroom air conditioning system

The cleanroom air conditioning system is a system that continuously delivers a certain amount of processed air into the cleanroom to maintain the required temperature, humidity, wind speed, pressure, and cleanliness parameters, in order to eliminate various thermal and humidity interferences and dust pollution inside and outside the cleanroom. Before the cleanroom is officially put into use, verification needs to be completed first. The validation of the cleanroom air conditioning system is a key component of the cleanroom validation process.