Static pressure difference and microbial determination of clean room workshop
Static pressure difference and microbial determination of clean room pharmaceutical cleanroom
Maintaining the static pressure difference of the clean room within the specified range can effectively control cross-contamination. The detection of static pressure difference must be carried out when all doors in the clean area are closed, and the test sequence should be performed in the clean room From the clean room with high cleanliness to the area with low cleanliness on the plane...
Text label: Determination of static pressure difference in clean room, microbial determination in clean room, Zhongjing Global purification
Clean room workshop static pressure difference, microbial determination
Maintaining the static pressure difference of the clean room within the specified range can effectively control cross-contamination. The detection of static pressure difference must be carried out when all doors in the clean area are closed, and the test sequence should be performed in the clean room On the plane, proceed from the clean room with high cleanliness to the area with low cleanliness, until the room directly connected to the outside is detected; the measuring pipe port should be located in the clean room where there is no air flow, and the plane of the measuring pipe port should be in the same direction as the airflow direction. Parallel; differential pressure gauge, the sensitivity of the instrument is determined by the control accuracy of the measured environmental pressure difference, it should be less than 0.1Pa, and the specification requires that the sensitivity should not be less than 2Pa. Close all doors during the test, and use a differential pressure gauge to measure between clean rooms, between clean rooms and clean corridors, between clean rooms and non-clean rooms, and between non-clean rooms and outdoor rooms according to the pre-designed measurement sequence pressure difference between. The pressure difference data marked on the test plan are compared with the pressure difference value required by the design or process. If the measured pressure difference is greater than or equal to the required pressure difference value, it is judged as qualified, but the measured pressure difference value should not exceed the pressure required by the standard. Too much difference, otherwise it will generate noise and affect the switching, and in severe cases, it will affect the airflow organization during switching.
There are two methods for the determination of suspended microorganisms in the air: the air suspension microorganism method and the sedimentation microorganism method, which are usually also called the planktonic bacteria and the sedimentation bacteria detection method; the planktonic bacteria detection method uses a sampler to collect the microbial particles suspended in the air to On a special medium, the sedimentation bacteria test method is to use a petri dish with a diameter of 90mm, and use the natural sedimentation principle to settle for 30min at the sampling point for sampling. Count after the production of bacteria; the sampling vessel and culture solution used must be disinfected and sterilized. The sampling points can be arranged evenly or at representative locations. The number of sampling points for the planktonic bacteria method can be the same as the number of points for measuring air cleanliness. The sampling time It should be determined according to the concentration of microorganisms in the air. Before microbial testing, the clean room must be in normal operation, and its temperature, air volume, wind pressure and wind speed must be controlled within the specified values; no more than 2 testers must wear clean work clothes; before sampling, for a one-way flow clean room, The normal operation time of the purification air-conditioning system shall not be less than 10 minutes, and for non-unidirectional flow clean rooms shall not be less than 30 minutes. The location of the sampling point in the working area is 0.8-1.5m from the ground, and sampling points can be added in key parts as needed. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean rooms.
Clean room plankton detection, sterilize the sampler and petri dish, the sampling port and sampling tube must be sterilized at high temperature before use; the tester should wear clean work clothes; Evaporate the residual disinfectant in the instrument, and then adjust the flow rate and rotation speed of the turntable; turn off the vacuum pump, put it in a petri dish, cover the lid, and adjust the sampler; after setting the sampling port and sampling point, turn on the sampler and vacuum pump at one time. After all the sampling is over, put the petri dish into a 37 ℃ constant temperature incubator for 48 hours, then count the number of colonies, and use a magnifying glass to check whether there is any omission. Sedimentation bacteria test method: put a plate with a diameter of 90mm injected into the culture medium out of the measuring point, open the cover and expose it for 30 minutes, gently push the cover on the edge of the culture dish with your fingers, cover it well, and put it into a special container for the culture dish If the culture dish is placed at a high density, cover the near area first, and then cover the distant culture dish to prevent the contamination of the culture dish caused by the capping operation; put the culture dish in a 37°C incubator Incubate for 48H, then count the number of colonies, and check with a magnifying glass for omissions.
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