How often is the sedimentation bacteria detected in the clean workshop and the standard for the detection of sedimentation bacteria in the clean workshop

The is a specially designed fortress to prevent harmful air particles and microorganisms from appearing in the working space, such as suspended particles, settled bacteria, planktonic bacteria and other pollutants. It ensures the health of employees and work efficiency within a certain range. Compared with ordinary workshops, clean workshops are more prominent in that they are dust-free, high cleanliness, and free of any pollutants. Next, sz-pharma will talk about how often the sedimentation bacteria in the is detected and the standard for the detection of sedimentation bacteria in the : GB/T16294-2010. 1. How often is the sedimentation bacteria detected in the 1. Testing time In order to ensure that the or clean area always meets the requirements during the operation, the basic contents of the (area) certification test include the air cleanliness level, static pressure difference, and wind speed and air volume. Determination. 'Clean Design Specification' stipulates that the air cleanliness level is less than or equal to 5, and the maximum time interval for the air cleanliness level certification test is 6 months; the air cleanliness level>Level 5, the longest interval of air cleanliness certification testing is 12 months; the longest interval of static pressure difference and air volume (wind speed) certification testing is 12 months; the longest testing interval of temperature, relative humidity, and noise is 12 months. 2. The layout of detection points is in accordance with the provisions of the National Standard of the People's Republic of China GBJ73-84 'Code for Design of Clean Workshops': when testing the cleanliness of the purification pharmaceutical cleanroom, the detection point should be within 1.00m of the horizontal plane from the indoor floor; The total number of measuring points in the flow-type purification pharmaceutical cleanroom should not be less than 20, and the distance between the measuring points should be 0.5-2.0m. The horizontal one-way flow measuring points are only arranged in the working area of ​​the first purification workshop; the non-unidirectional flow purification workshops are arranged with 5 measuring points according to the area of ​​the purification workshop less than or equal to 50 square meters. 2. Detection standard for sedimentation bacteria in : GB/T16294-2010 The sedimentation bacteria in refers to the method mentioned in GB/T16294-2010 standard to collect live microbial particles in the air, and through special medium, in a suitable Propagated to visible colonies under growth conditions. Basically, in hospital clean room, cosmetic clean room, disinfectant workshop, electronics factory clean room, GMP workshop (pharmaceutical factory), biological safety cabinet, dairy product pharmaceutical cleanroom, food clean room, medical pharma machinery clean room, water clean room In the detection of other clean workshops, the detection of sedimentation bacteria is often involved, but each type is not completely the same: different standards have slightly different regulations on the number of sedimentation bacteria plates. In the layout position, there are also big differences in individual standards, and the detection method should be determined according to the specific situation. For example, in 'Clean Room Construction and Acceptance Specifications' GB50591-2010, the number of sampling points: the number of petri dishes should not be less than the number of measurement points for particle count concentration, if there are no special requirements for the process, it should be greater than or equal to the minimum petri dishes in the table below Count, and add 1 control dish each. Each clean room or each control area should have a negative control dish. In 'Test method for sedimentation bacteria in clean room (area) of pharmaceutical industry' GB/T16294-2010, the number of sampling points: the minimum number of sampling points for sedimentation bacteria test refers to the provisions of GB/T16292-2010, while meeting the minimum sampling points , should also meet the minimum number of petri dishes. In the 'Technical Specifications for the Construction of Hospital Clean Operation Department' GB50333-2013, the number of sampling points: the number of sedimentation bacteria measurement points should be the same as the number of dust concentration measurement points, and at the same time meet the requirements of the minimum number of petri dishes. The purpose of the sedimentation bacteria test in the clean room inspection is to prove that the sedimentation bacteria in the clean room meet the design requirements. For the detection method of sedimentation bacteria, refer to GBT 16294-2010

Test method for sedimentation bacteria in clean room (area) of pharmaceutical industry. This collection method relies on the natural sedimentation of particles in the air on the agar plate. Because the particle sedimentation speed is very slow, the medium plate needs to be exposed to the air for a long time. Generally, the exposure time of the culture plate does not exceed 4h. When testing in the , place the petri dish on the work surface or the ground, refer to the sampling point for the dust particle number test for location and layout, and wait for the bacteria to settle down naturally. Incubate at 35°C for 48 to 72 hours. After the incubation, count and mark all the colonies on the petri dish with the naked eye, and then use a 5-10 times magnifying glass to check whether there are any omissions, count the results and fill in the test records. The size of the sedimentation bacteria culture dish is generally 90mm. The acceptance standard of the sedimentation bacteria refers to the 2010 version of GMP and the 2010 version of the GMP guide. The dynamic indicators of the sedimentation bacteria are as follows: Class A cleanliness level<1cfu

/4 hours, Class B cleanliness level<5cfu/4 hours, C-class cleanliness level<50 cfu/4 hours, Class D cleanliness level<100 cfu

/4 hours, the control dish was negative.

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