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The scope, purpose and requirements of GMP detection in the Pharmaceutical Workshop

Apr 13, 2018

In the actual production, after the completion of construction, such as GMP and other clean workshop in pharmaceutical workshop, third party inspection and debugging are often needed. In the process of testing the GMP in the pharmaceutical workshop, the contents include the assessment of the environmental grade of the clean room, the inspection of the acceptance of the project and so on. The test items mainly include the wind speed, the frequency of air change, the temperature and humidity, the pressure difference, the suspended particles, the zooplankton, the sedimentation bacteria, the noise and the illumination.


So, what is the specific test? What is the purpose of testing? First of all, in the pharmaceutical workshop, we must first detect its speed, air volume and air change times. We should know that the cleanliness of the clean room and the clean area is mainly achieved by sending enough clean air to discharge and dilute the particulate pollutants produced in the room. Therefore, it is very necessary to determine the air volume, the average wind speed, the uniformity of air supply, the flow direction and the flow pattern of clean rooms or clean facilities.


Next is to detect the temperature and humidity in the clean area of the Pharmaceutical Workshop. The measurement of temperature and humidity is usually divided into two grades: General test and comprehensive test. The first grade is suitable for the acceptance test in the empty state. The second level is suitable for static or dynamic comprehensive performance testing. This kind of test is suitable for occasions with strict performance requirements for temperature and humidity.


Next, the size of the pressure difference in the pharmaceutical workshop is also tested. The purpose of this test is to verify the ability to keep the pressure difference between the completion facilities and the surrounding environment and the space between the facilities.


In general, in the process of pressure differential testing in the pharmaceutical workshop, all the doors are required to be closed, and then from high pressure to low pressure, the furthest inside and outside rooms of the outside world. Attention is paid to the different levels of adjacent clean areas with holes in the pharmaceutical workshop, and reasonable flow direction should be provided at the outlets.http://www.wxrfcleanroom.com/