Air pressure standard in filling room of production plant

The air pressure standard of the filling room in the production plant is as follows:

1. core standard: pressure difference between clean area and non-clean area ≥ 10 Pa SCA (Pa)

1. legal Basis
   according to Article 48 of China's current Good Manufacturing Practice (GMP) and GB 50457-2019 Design Standard for Clean Workshop in Pharmaceutical Industry, the pressure difference between the filling room (clean area) and the non-clean area must not be less than 10 Pa. This standard is also applicable to the clean production environment of food, cosmetics and other industries, aiming to prevent external pollutants (such as dust, microorganisms) from pouring back, and to ensure product sterility or cleanliness.

2. international comparison

   • EU GMP: The recommended pressure difference is 10-15 Pa, which is consistent with our national standard.
   • US FDA: Required pressure difference ≥ 12.5 Pa, slightly higher than China's standard.
   • Industry differences the food or biosafety industry may adjust pressure differentials based on risk, but 10 Pa is the mandatory minimum for pharmaceutical production.

Core purpose of 2. differential pressure control

1. prevent pollution backflow
   maintaining a pressure differential of 10 Pa ensures a unidirectional flow of air (from high cleanliness to low cleanliness), reducing the risk of cross-contamination. For example, when filling operations involve aseptic products, insufficient differential pressure can lead to excessive microbiological levels, affecting drug or food safety.

2. dynamic environment stability

   • buffer Design: The gradient is maintained through the air lock chamber or buffer chamber, and the pressure difference between adjacent rooms is controlled within the range of 5-20 Pa.
   • alarm mechanism: When the pressure difference is lower than the set value (such as 10 Pa), an alarm is triggered and the air conditioning system is adjusted in time.

3. Implementation Points and Monitoring Requirements

1. daily monitoring
   • frequency: Record the differential pressure at least twice a day.
   • Tools: Use a micro-differential pressure gauge to ensure that the threshold is not lower than 10 Pa.
   • Maintenance: If the differential pressure is lower than the specified range, the filter may be blocked and the filter needs to be cleaned or replaced.
2. Industry-specific requirements
   • cosmetics industry:
     • ≥ 10 Pa between clean area and non-clean room; ≥ 8 Pa between clean rooms of different levels; ≥ 3 Pa between core control area and non-core control area of the same level.
     • For example, a pressure difference of 3 Pa should be maintained between the filling room and the stationary room and the clean container storage room to prevent pollution sources from being sucked into the filling shop.
   • Food Industry:
     • the clean area shall keep positive pressure (≥ 5 Pa) for the non-clean area to prevent pollution from flowing back.
     • Ready-to-eat food, aseptic filling area to ISO 5 or GMP A/B, air to high efficiency filter (HEPA H13/H14).

4. compressed air supply pressure standard

1. general Requirements
   • main pipe pressure: The gas supply pressure of the main pipeline for pneumatic drive in the factory shall not be less than 0.7 MPa.
   • Gas point pressure: The gas consumption point is generally adjusted to 0.4-0.5 MPa.
   • Air compressor output: The output pressure of the air compressor is usually not less than 7-8 bar (that is, 0.7-0.8 MPa), and the pressure of the gas tank is not less than 7 bar.
2. Industry Special Needs
   • pharmaceutical Production: Some processes (such as biological fermentation, cell culture) may require sterile, impurity-free purified air, and the pressure needs to be adjusted according to equipment requirements.
   • Food Filling: The quality of compressed air should be oil-free and water-free, and the pressure may reach 0.7 MPa (such as the demand of a certain project).