Cleanliness level of food and drug GMP workshop

The sanitation control of the food production environment is directly related to the sanitation quality and food safety, and the control of the food production environment sanitation involves many factors in the clean operation area of food production, including the division and isolation of different operation areas, and the cleaning of personnel entering different operation areas. Process, quality of raw and auxiliary materials and cleaning process, flow line, environmental ventilation system, equipment and appliance configuration level and cleaning and disinfection, environmental sanitation cleaning and disinfection, etc.

Air cleanliness level of medical clean room

Standards for airborne particles in clean areas

Dynamic grading standards for microbial monitoring in clean areas


The cleanliness level of the food and drug GMP workshop and the eight indexes of suspended particles:
1. Level A: High-risk operation areas, such as filling areas, areas where rubber stopper barrels and open packaging containers are in direct contact with sterile preparations, and areas where there is no jun assembly or connection operation, should use a one-way flow operation platform (Cover) Maintain the environmental state of the area. The unidirectional flow system must supply air evenly in its working area, and the wind speed is 0.36-0.54m/s (guide value). There should be data to prove the state of the one-way flow and be verified. (In a closed isolation manipulator or glove box, lower wind speeds can be used)
2, Class B: Refers to the background area where the Class A clean area is located without high-risk operations such as jun preparation and filling.
3, Class C and Class D: Refers to the clean area where there is no less important operation step in the production process of jun medicines.
4. Regarding the maximum allowable number of static suspended particles/m3:
Class A: static→≥0.5μm→3520; static→≥5.0μm→20
Class B: static→≥0.5μm→3520; static→≥5.0μm→29
C level: static→≥0.5μm→352000; static→≥5.0μm→2900
Class D: static→≥0.5μm→3520000; static→≥5.0μm→29000
5. Maximum allowable number of dynamic suspended particles/m3:
Class A: Dynamic→≥0.5μm→3520; Dynamic→≥5.0μm→20
Class B: Dynamic→≥0.5μm→352000; Dynamic→≥5.0μm→2900
C level: dynamic→≥0.5μm→3520000; dynamic→≥5.0μm→29000
Class D: dynamic→≥0.5μm→no regulation; dynamic→≥5.0μm→no regulation
The following criteria should be met when the suspended particles are dynamically monitored:
1. Determine the location of the sampling point and conduct daily dynamic monitoring based on the cleanliness level and the confirmed results of the air purification system and risk assessment.
2. In the whole process of key operations, including equipment assembly operations, suspended particle monitoring should be carried out in Class A clean areas. When the pollution in the production process (such as living organisms, radiation hazards) may damage the dust particle counter, the test should be carried out during the equipment debugging operation and simulation operation.
3. The frequency and sampling amount of the A-level clean area monitoring should be able to detect human intervention, accidental events and any system damage in time. When filling or sub-packing, because the product itself produces particles or droplets, the suspended particles with a filling point ≥5.0um are allowed to appear that does not meet the standard.
4. A monitoring system similar to the A-level clean area can be used in the B-level clean area. The sampling frequency and sampling amount can be adjusted according to the degree of influence of the Class B clean area on the adjacent Class A clean area.
5. The suspended particle monitoring system should consider the influence of the length of the sampling tube and the radius of the bend on the test results.
6. The sampling volume for daily monitoring may be different from the air sampling volume when the cleanliness level and air purification system are confirmed.
7. In the Class A clean area and Class B clean area, when a small amount of suspended particles ≥5.0μm appears continuously or regularly, an investigation should be carried out.
8. In the clean workshop inspection, after all the production operations are completed, the operators have withdrawn from the production site and self-cleaned after 15-20 minutes (guide value), the suspended particles in the clean area should reach the "static" standard in the table.
9. The C-level clean area and the D-level clean area (if necessary) shall be dynamically monitored in accordance with the principles of quality risk management. Monitoring requirements, warning limits and correction limits can be determined according to the nature of the operation, but the self-cleaning time should meet the specified requirements.
10. Temperature, relative humidity and other parameters should be formulated according to the nature of the product and operation, and these parameters should not have an adverse effect on the specified cleanliness.