In the pharmaceutical industry, clean compressed air, as a crucial process gas, directly affects the quality and safety of pharmaceuticals. As a professional manufacturer of purification equipment, Guangzhou Cleanroom Construction Co., Ltd. fully understands its importance. Today, we will introduce in detail the daily monitoring and standards of clean compressed air in pharmaceutical clean rooms.

During the pharmaceutical manufacturing process, compressed air is widely used in multiple aspects such as material transportation, equipment driving, and fermentation cultivation. If the compressed air contains impurities like dust particles, microorganisms, moisture, and oil, it may contaminate pharmaceuticals, affecting their purity, stability, and effectiveness. In severe cases, it may even lead to substandard pharmaceutical products and endanger the health of patients. Therefore, daily monitoring of clean compressed air is an essential measure to ensure that pharmaceutical production complies with regulations and quality requirements.

: This is one of the important indicators for measuring the cleanliness of compressed air. Through professional dust particle counters, the number of particles within different particle size ranges can be detected. Usually, attention is paid to the number of particles with particle sizes such as 0.1μm, 0.2μm, 0.5μm, 1.0μm, and 5.0μm. Different areas in pharmaceutical clean rooms have strict limitations on particle counting according to their cleanliness level requirements. For example, in the Grade A clean area, the allowable number of tiny particles is extremely low, which requires that the particle count of the compressed air must be maintained at an extremely low level to prevent particles from contaminating the pharmaceutical production process.

: Microbial contamination is a significant risk in pharmaceutical production. Microorganisms in compressed air may come from the air source, inside the compression system, or the pipeline system. By using appropriate microbial samplers and culturing methods, the number of bacteria, fungi, and other microorganisms in the compressed air can be detected. Pharmaceutical workshops usually require that the microbial content in compressed air meets strict standards, generally measured by the number of colony-forming units (CFU) per cubic meter of air, ensuring that it is within a safe range to prevent microorganisms from breeding and spreading during the pharmaceutical production process and thus affecting the quality of pharmaceuticals.

: Moisture in compressed air may cause pipeline corrosion, microorganism growth, and may also have an adverse impact on pharmaceutical quality in certain pharmaceutical processes. Commonly used moisture detection methods include dew point meter for measuring dew point temperature and electrolysis method for measuring moisture content. According to different process requirements, the moisture content of compressed air needs to be controlled within a certain range. For example, in some freeze-drying processes that are sensitive to moisture, the dew point requirement for compressed air is extremely strict, and it must be ensured that its dryness meets the process standard.

: Lubricating oil may be brought into the compressed air from the compressor. If not controlled, oil droplets may contaminate pharmaceuticals or affect the normal operation of production equipment. By using oil mist detectors and other equipment, the oil content in compressed air can be monitored. Pharmaceutical workshops generally require that the oil content in compressed air is extremely low, even reaching an oil-free level standard, to avoid potential hazards to pharmaceuticals and the production process.

: For key production areas and high-risk process links, such as the filling area of sterile pharmaceuticals, high-frequency monitoring is usually required, and tests may need to be carried out daily or per shift. For some relatively low-risk areas or auxiliary production links, the monitoring frequency can be appropriately reduced, but it should also be tested at least once a week or once a month to ensure the continuous stability of the compressed air quality.

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The pharmaceutical industry is strictly regulated by laws and regulations, and the quality of clean compressed air must comply with relevant international, national, and industry standards. For example, the ISO 8573 international standard provides detailed classifications and regulations on the contents of impurities such as particles, moisture, and oil in compressed air. The "Good Manufacturing Practice for Pharmaceutical Products (GMP)" in China also clearly defines the quality requirements for compressed air in pharmaceutical clean rooms. Each pharmaceutical enterprise must establish a complete compressed air quality management system based on these standards and regulations to ensure that the compressed air used in its production process continuously meets the specified quality standards, safeguarding the quality and safety of pharmaceuticals from the source.

In conclusion, the daily monitoring and standards of clean compressed air in pharmaceutical clean rooms are an indispensable part of the pharmaceutical production process. Only by strictly monitoring and controlling according to the standards and ensuring the high quality of the compressed air can a safe, stable, and clean environment be provided for pharmaceutical production, guaranteeing the quality and efficacy of pharmaceuticals and safeguarding public health. Guangzhou Cleanroom Construction Co., Ltd. is committed to providing advanced purification equipment and professional technical support for pharmaceutical enterprises, helping them meet the quality requirements of clean compressed air and facilitating the high-quality development of the pharmaceutical industry.

If you have any questions or needs regarding the purification equipment or compressed air treatment in pharmaceutical clean rooms, please feel free to contact us.