Purification Workshop Plant and Facility Verification
Purification Plant and Facility Verification
The verification of the purification pharmaceutical cleanroom is mainly to check the design of the factory, whether the factory area is planned according to the production, administration, living and auxiliary areas, whether the surrounding environment of the factory, the dust content in the atmosphere, the factory area or the road outside the workshop meet the requirements, the production workshop, clean area , quality inspection room, warehouse, etc...
Text label: purification workshop, facility verification, design, construction, installation and construction
Purification Plant and Facility Verification
The verification of the purification pharmaceutical cleanroom is mainly to check the design of the factory, whether the factory area is planned according to the production, administration, living and auxiliary areas, whether the surrounding environment of the factory, the dust content in the atmosphere, the factory area or the road outside the workshop meet the requirements, the production workshop, clean area , Whether the interior decoration of the quality inspection room and warehouse meets the specified requirements, whether the personnel and logistics are separated, whether the ground and walls are flat, seamless, and easy to clean. Verify the rationality of the layout and process of the purification plant: confirmation to reduce human error; confirmation to prevent cross-contamination; confirmation of product quality assurance system; confirmation of building materials and equipment suppliers. Verification of sanitation facilities: the routes for production personnel to enter and exit the workshop are designed and constructed as required; production tools and appliances are provided with special cleaning rooms; the washing of work clothes is designed and constructed as required; cleaning tools are provided with special cleaning and disinfection rooms. Verification of power supply system, lighting system: installation test, illuminance measurement confirmation.
The verification of clean facilities should firstly carry out instrument calibration, including thermometers, hygrometers, pressure gauges, air volume hoods, sound level meters, illuminance meters, dust particle counters, bacterial samplers, electrical instruments, and leak detectors. For the air purification treatment with air cleanliness level of 100,000 and higher, three-stage filtration of primary, medium, and high-efficiency air filters should be used. Among them, the air purification treatment of 100,000-level air can also be replaced by sub-high-efficiency air filters. High-efficiency air filter; oil-immersed filter should not be used for primary-efficiency filter, high-efficiency air filter or sub-high-efficiency air filter should be installed at the terminal of the purification air conditioning system, and high-efficiency or sub-high-efficiency air filter must be tested for leaks . The leak detection test checks the quality of the filter and whether there are cracks in the installation connection to ensure the purification effect of the purification plant; there are two methods for the leak detection test, one is a dust particle counter, and the other is to use aerosol as the dust source with aerosol Photometer leak detection; high efficiency filter PAO leak detection test mainly checks the small pinholes of the filter medium and other sealing procedures such as frames and gaskets. When the photometer shows that the transmittance exceeds the standard, the filter is judged to be unqualified and needs to be repaired or replaced. ;High-efficiency filter material leaks are allowed to be repaired with special silica gel glue, but the area of u200bu200ba single leak shall not be greater than 1% of the total area, and the area of u200bu200ball leaks shall not be greater than 5% of the total area, otherwise it must be replaced, and the high-efficiency filter must be repaired and After replacement and reinstallation, the leak detection must be re-tested. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification plants and clean workshops.
Suspended particle sampling point, for the general air purification system and laminar flow hood with the high-efficiency filter installed at the end, only the monitoring point needs to be set up in the working area; but the high-efficiency filter is installed in the air conditioner and the end is a sub-high-efficiency filter In addition to setting up monitoring points in the work area, a monitoring point should also be set up at each air supply outlet. The unit of wind speed of the high-efficiency air filter is m/s, and the unit of air volume flow is m3/h; the wind speed of the high-efficiency filter can be measured at the same time as the PAO leak detection, and the wind speed refers to the surface wind speed at the outlet, which is generally controlled at ≥ 0.3m/ s or more, if it is less than 0.3m/s, it means that the filter is blocked and should be replaced in time; the measurement content of the air volume flow of the air purification system includes the measurement of the total air supply volume, fresh air volume, primary and secondary return air volume, exhaust air volume and each dry air volume. , the air volume in the branch air duct and the air volume flow of the air outlet, etc., to verify the air volume of the room that needs to be measured, that is, the air volume of the air outlet, and use this to calculate the number of air changes in the room.
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