GMP workshop clean area division and requirements
GMP pharmaceutical cleanroom clean area division and requirements
GMP workshop cleanliness grades are divided into four grades: A, B, C, D, which are also divided into static and dynamic. Grade A: high-risk operation areas, such as filling areas, placing rubber stopper barrels and direct contact with sterile preparations Areas of contact with open packaging containers and areas of aseptic assembly or connection operations should be...
Text label: GMP workshop requirements, clean area level and division, Zhongjing Global Purification
GMP workshop clean area division and requirements
GMP workshop cleanliness grades are divided into four grades: A, B, C, D, which are also divided into static and dynamic. Grade A: high-risk operation areas, such as filling areas, placing rubber stopper barrels and direct contact with sterile preparations The area of u200bu200bcontact with open packaging containers and the area of u200bu200baseptic assembly or connection operation should be maintained in the environmental state of the area with a one-way flow operation table; the one-way flow system must be evenly supplied with air in its working area, with a wind speed of 0.36-0.54 m/s, there should be data to prove the state of one-way flow and verified, and lower wind speeds can be used in closed isolated operating areas or glove boxes. The air temperature in the clean operation area is 20-24°C, the relative humidity of the air in the clean operation area is 45%-60%, the horizontal wind speed in the operation area is ≥0.54m/s, and the vertical wind speed is ≥0.36m/s. Leak rate > 99.97%, illumination > 300-600Ix, noise ≤ 75dB.
Class B is the background area where the clean area of u200bu200bClass A is located for operations such as aseptic preparation and filling; Class C and Class D are clean areas with less important operation steps in the production process of sterile drugs. The air temperature in the clean operating area of u200bu200bClass B and Class C is 20-24℃, the relative humidity of the air in the clean operating area is 45%-60%, the number of air changes in the room is ≥ 25 times/H, and the relative outdoor pressure difference in Class B and C areas is ≥ 10Pa, different areas of the same level should maintain a certain pressure difference according to the airflow direction, the leak detection rate of the high-efficiency filter is > 99.97%, the illumination > 300-600Ix, and the noise is ≤ 75dB. The air temperature in the Class D clean operation area is 18-26°C, the relative humidity of the air in the clean operation area is 45%-60%, the number of air changes in the room is ≥ 15 times/H, the relative outdoor pressure difference in the 100,000-level area is ≥ 10Pa, high-efficiency filtration The leak detection rate of the detector is >99.97%, the illumination >300-600Ix, and the noise ≤75dB. In order to confirm the clean area, the sampling volume of each sampling point shall not be less than 1m3, the level of air suspended particles in the A-level clean area is ISO4.8, and the suspended particles of ≥5μm are the limit standard, and the air-suspended particles in the B-level clean area are The level is ISO5. For the C-level clean area, the levels of airborne particles are ISO7 and ISO8, respectively. For the D-level clean area, the level of airborne particles is ISO8; when confirming the level, the portable dust particles with short sampling should be used for management. Counter to avoid sedimentation of ≥5μm suspended particles in the long sampling tube of the remote sampling system. In the unidirectional flow system, the dynamic sampling head should be used; the dynamic test can be carried out during the routine operation and the simulated filling process of the culture medium, and it is proved that the Dynamic cleanliness levels. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification plants.
Monitoring points should be based on the results and risk assessment of the cleanliness level and air purification system confirmation, determine the location of the sampling point and conduct daily dynamic monitoring. The sampling volume of daily monitoring can be compared with the cleanliness level and air purification system confirmation The sampling volume is different; the monitoring frequency and sampling volume of the A-level clean area should be able to detect human intervention, accidental events and system damage in time. The suspended particles of 5μm do not meet the standard; the B-level clean area can adopt a monitoring system similar to that of the A-level clean area, and the sampling frequency and sampling amount can be adjusted according to the influence of the B-level clean area on the adjacent A-level clean area. .
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