What are the compressed air quality standards for food and drug production processes?

The food and drug production process has strict standards for compressed air quality. These standards are designed to ensure the purity of the air in the production process and avoid pollution to the product and the environment. The following are the main contents of compressed air quality standards for food and drug production processes based on publicly released information:

quality standard for compressed air in 1. food production process

1. international Standards:
   • ISO 8573-1: This is the international standard for the purity level of compressed air, which stipulates the maximum allowable content of solid particles, water and oil. Food plants usually need to achieve at least ISO 8573-1:2010 Class 1.2.1 or higher purity level, I .e. solid particles ≤ 0.1 μm (microns), moisture at pressure dew point -40 ℃, oil fraction ≤ 0.01 mg/m & sup3;.
2. Domestic Standards:
   • GB (national standard): China has its own food safety regulations and standards, such as the GB hygiene requirements for food contact materials and equipment, which may indirectly affect the design and operation of compressed air systems.
   • GMP regulations for the food industry: There are also specific standards for the water content and oil content of compressed air.
3. Specific indicators:
   • microbial index microorganisms are one of the important factors affecting food safety, and the number and types of microorganisms should be strictly limited.
   • Particulate Matter Index particulate matter may carry bacteria, viruses and other harmful substances, causing pollution to food, the concentration of particles, particle size and other parameters should be limited.
   • Water vapor index: The presence of water vapor in compressed air will cause corrosion to food production equipment, and it will also affect the quality of food. The content of water vapor should be limited.
   • Chemical substance index: Certain chemicals may exist in compressed air, which may cause food contamination and need to be controlled.
   • Pressure and flow indicators the stability and range of the pressure and flow of compressed air should be limited to ensure the stability and reliability of the food production process.

Quality standard for compressed air in 2. pharmaceutical production process

1. GMP Standard:
   • the "Good Manufacturing Practice" (GMP) appendix "Sterile Drugs", "Traditional Chinese Medicine Preparations", "Biological Products" and "Blood Products" stipulates that the compressed air used for drug production should meet the national drug packaging container sealing performance and sterilization requirements, And after sterilization and filtration treatment.
2. International Standard Reference:
   • the US Food and Drug Administration (FDA) has strict requirements for compressed air quality to ensure the safety and reliability of compressed air used in medical, pharmaceutical and other critical industries. These requirements include that the content of particles, microorganisms, gases and water in the compressed air must be within the specified limits.
3. Specific indicators:
   • dust dust is one of the common pollutants in compressed air. The pharmaceutical industry has very strict requirements on dust. The specific standards vary with different pharmaceutical production processes. Generally, the particle size channel is controlled to be 0.5 micron particles, and the number of 5.0 micron particles is 0.
   • Microorganisms the requirements for microorganisms in the standard are also very strict. The specific standards vary with different drug production processes, generally no more than a few microorganisms per cubic meter of air.
   • water vapor the standard requires that the content of water vapor must be controlled within a certain range to prevent water vapor condensation from affecting the quality of drugs and production equipment. Generally, the dew point -40 ℃ standard or dew point -20 ℃ is selected.
   • Oil content: generally requires secondary level, 0.1 mg/m & sup3;, there are also special first-class standard 0.01 mg/m & sup3;.

3. assurance measures

in order to ensure that the food and drug production process of compressed air quality standards, the following measures need to be taken:

1. select qualified air compressor: Ensure that the quality of the compressed air produced meets the standard, and carry out regular maintenance and maintenance.
2. Installing the filter: Install a filter in the compressed air pipeline to remove particulate matter, microorganisms and other pollutants in the air.
3. Establishment of monitoring system real-time monitoring and recording of various indicators of compressed air, timely detection and treatment of problems.
4. Regular testing: Fully understand the quality of compressed air to ensure that it fluctuates within a reasonable range.

In short, the food and drug production process has very strict requirements on the quality of compressed air, and it is necessary to follow relevant standards and regulations, and take effective measures to ensure that the quality of compressed air meets the standards.