Hygienic standard for ventilation air and compressed air in pharmaceutical factory

Hygienic standards for ventilation air and compressed air in pharmaceutical plants are essential to ensure the quality and safety of pharmaceutical production. The following are the main sanitary standards for ventilation air and compressed air in pharmaceutical plants according to relevant standards and data:

hygienic standard for 1. ventilation air

the sanitary standards of ventilation air in pharmaceutical factories mainly involve air cleanliness, temperature and humidity control, microbial control and so on. The purpose of these standards is to create a clean and suitable production environment to prevent drug contamination.

1. Air cleanliness:
   • the air cleanliness of the purification workshop of the pharmaceutical factory should be determined according to the requirements of the production process, and the areas with different cleanliness levels have different control standards. For example, 100-level and 1000-level clean areas have strict restrictions on the number of suspended particles in the air.
   • Air cleanliness should be regularly monitored in clean areas to ensure compliance with established standards.
2. temperature and humidity control:
   • the temperature and humidity of the clean workshop should be adjusted and controlled according to the requirements of the production process. Generally speaking, the air cleanliness level 100, 1000 level area generally control the temperature of 20~24 ℃, relative humidity of 45 ~ 60%.
   • The temperature and humidity control should be stable and reliable to avoid the impact of excessive fluctuations on drug production.
3. microbial control:
   • the number of microorganisms should be strictly controlled in the clean area to prevent microbial contamination of drugs.
   • Microbiological monitoring should be carried out on a regular basis, including air, surface, personnel, etc.
4. Ventilation:
   • clean workshop should maintain good ventilation conditions, to ensure that the air fresh, no smell.
   • The ventilation system should be cleaned, disinfected and maintained regularly to ensure its normal operation and sanitary condition.

Hygienic standard for 2. compressed air

pharmaceutical factories have strict requirements on the quality of compressed air to ensure that it will not cause pollution to the medicine when it is used in the production process.

1. Oil content:
   • chinese Pharmacopoeia and GMP require compressed air oil content ≤ 0.1 mg/m & sup3;. Some standards require even lower requirements, such as oil content should be less than 0.01 mg/m & sup3;(surface area method) or less than 0.08 mg/m & sup3;(gravimetric method).
   • The compressed air must not contain obvious grease to prevent contamination of the drug.
2. Humidity:
   • the relative humidity of the compressed air should be kept between 40% and 60% to prevent the deterioration of the medicine due to moisture during production and storage.
3. Microorganisms and particulate matter:
   • there should be no obvious particulate matter, grease, microorganisms and other pollutants in the compressed air.
   • Compressed air should be regularly tested for microbiological and particulate matter to ensure compliance with health standards.
4. Pressure dew point:
   • the dew point should be lower than -40 ℃ to ensure that the moisture in the compressed air exists in solid form and will not condense into liquid water to contaminate the drug.
5. Dust particle size:
   • the particle size of solid particles should be less than or equal to 0.1 μm to prevent contamination of pharmaceutical production by particulate matter.
6. Cleanliness:
   • compressed air needs to meet certain cleanliness standards to prevent contamination of medicines.
7. Aseptic processing:
   • compressed air used for drug packaging or direct contact with drugs should be sterilized to ensure its sterile state.
8. Smell:
   • compressed air should be odor-free to prevent adverse effects on medicines.

In summary, the sanitary standards for ventilation air and compressed air in pharmaceutical factories involve many aspects, including air cleanliness, temperature and humidity control, microbial control, oil content, humidity, microorganisms and particulate matter, pressure dew point, dust particle size, cleanliness and aseptic treatment. Pharmaceutical factories should strictly abide by these standards to ensure the quality and safety of drug production.