GMP testing requirements of Pharmaceutical Workshop

After the construction of GMP workshop, electronic dust-free workshop, food and drug packaging material workshop, sterile medical equipment workshop, hospital clean operating room, biosafety laboratory, health food GMP workshop, cosmetics / consumer goods workshop, animal laboratory, veterinary medicine GMP workshop, drinking bottled water workshop and other clean rooms, clean workshops generally need third-party testing and debugging Testing scope: clean room environmental rating, engineering acceptance testing, including food, health products, cosmetics, bottled water, milk production workshop, electronic product production workshop, GMP workshop, hospital operating room, animal laboratory, biosafety laboratory, biosafety cabinet, ultra clean workbench, dust-free workshop, sterile workshop, etc Test items: wind speed and air volume, air change times, temperature and humidity, pressure difference, suspended particles, floating bacteria, settling bacteria, noise, illumination, etc 1 Air speed, air volume, air change times, cleanliness of clean room and clean area are mainly achieved by sending enough clean air to replace and dilute the particulate pollutants produced in the room Therefore, it is necessary to measure the air supply volume, average air speed, air supply uniformity, air flow direction and flow pattern of clean rooms or facilities The unidirectional flow mainly depends on the clean airflow to push and displace the polluted air in the room and area to maintain the cleanliness of the room and area Therefore, the wind speed and uniformity of the air supply section are important parameters affecting the cleanliness Higher and more uniform cross-section wind speed can remove pollutants produced in indoor process faster and more effectively, so they are the main detection items of concern Non unidirectional flow mainly relies on the incoming clean air to dilute and dilute the pollutants in the room and area to maintain its cleanliness Therefore, the larger the number of air changes, the reasonable flow pattern, the more significant the dilution effect, and the higher the cleanliness Therefore, the air volume of non single phase flow clean room and clean area and the corresponding air change times are the main air flow test items In order to obtain repeatable readings, record the time average value of wind speed at each measuring point Air change times: according to the total air volume of the clean room in addition to the volume of the clean room, 2 Temperature and humidity measurement of the clean room or clean facilities, usually divided into two grades: General test and comprehensive test *The second level is applicable to static or dynamic comprehensive performance test This kind of test is suitable for the occasions with strict requirements on temperature and humidity performance This test is carried out after air flow uniformity test and air conditioning system adjustment By the time of this test, the air conditioning system has been fully operated and all conditions have been stable At least one humidity sensor shall be set in each humidity control area, and sufficient stabilization time shall be given to the sensor The measurement shall be suitable for the purpose of actual use The measurement shall not be started until the sensor is stable, and the measurement time shall not be less than 5 minutes 3 Differential pressure the purpose of this test is to verify the ability to maintain a specified differential pressure between the completed facility and the surrounding environment, and between spaces within the facility This test is applicable to all three occupancy states This test needs to be carried out on a regular basis Under the condition that all doors are closed, the test of pressure difference should start from high pressure to low pressure, from the interior room far away from the outside Zui in the plane layout, and then test outwards in turn; for the clean rooms (areas) with different levels of holes connected, the holes should have reasonable air flow direction, etc Pressure difference detection requirements: (1) the measurement of static pressure difference shall be carried out when all doors in the clean area are closed (2) on the clean plane, the cleanliness shall be from high to low, and the room directly leading to the outdoor shall be detected (3) the pipe orifice can be set at any place where there is no air flow influence in the room, and the surface of the pipe orifice is parallel to the air flow streamline (4) the measured and recorded data shall be 1.0pa Pressure difference detection steps: (1) close all doors first (2) use a micro differential pressure meter to measure the pressure difference between the clean rooms, between the clean room corridors, and between the corridors and the outside (3) record all data The pressure difference standard requires that the positive or negative pressure value of the tested clean room be maintained according to the clean room design or process requirements (1) the static pressure difference between clean rooms or clean areas and non clean rooms (areas) of different levels shall not be less than 5pa (2) the static pressure difference between clean room (area) and outdoor shall not be less than 10Pa (3) when the one-way flow clean room with air cleanliness level higher than level 5 (level 100) is opened, the dust concentration of the indoor working face 0.6m inside the door shall not be greater than the dust concentration limit of the corresponding level (4) if the requirements of the above standards are not met, the new air volume and exhaust air volume shall be readjusted until they are qualified 4 Suspended particles a the indoor test personnel must wear clean clothes, no more than 2 people, be located at the downwind side of the test point and far away from the test point, and keep still The operation of changing points should be light, and the interference of personnel to indoor cleanliness should be reduced B the equipment shall be used within the calibration period C before and after the test, the equipment shall be "reset" D in the unidirectional flow area, the selected sampling probe shall be close to the isokinetic sampling, and the deviation between the wind speed entering the sampling probe and the wind speed of the air to be collected shall not exceed 20% If this is not possible, the sampling port is facing the main direction of the air flow For the sampling point of non unidirectional flow, the sampling port shall be vertical upward E the connecting pipe from sampling port to particle counter sensor shall be as short as possible Generally, the sampling point is about 0.8-1.2m away from the ground, which should be evenly and scientifically distributed, and should avoid the air outlet For any small clean room or local air purification area, the number of sampling points shall not be less than 2 The total number of sampling points can be obtained by opening 2 roots according to the area 5 The number of less sampling points of zooplankton Zui corresponds to the number of sampling points of suspended particles The location of the measuring points in the working area is about 0.8-1.2m away from the ground, and the location of the measuring points in the air supply outlet is about 30cm away from the air supply surface The measuring points can be increased at the key equipment or the key working activity range Each sampling point is generally sampled once After all the samples are collected, the culture dish shall be placed in a constant temperature incubator for at least 48 hours Each batch of culture medium shall have a control experiment to check whether the culture medium is polluted 6 The measuring point of the settling bacteria working area is about 0.8-1.2m away from the ground Place the prepared Petri dish at the sampling point, open the Petri dish cover to expose it for the specified time, then cover the Petri dish, and place the Petri dish in a constant temperature incubator for culture for at least 48 hours Each batch of culture medium should have a control experiment to check whether the culture medium is polluted 7 Noise measurement height is about 1.2m away from the ground If the clean room area is less than 15 square meters, only one point in the center of the room can be measured If the area is more than 15 square meters, four more diagonal points shall be measured, one meter away from the side wall, and the measuring points shall face each corner 8 Illuminance: the measuring point plane is about 0.8m away from the ground, and points are arranged at a spacing of 2m The measuring points of rooms within 30m2 are 0.5m away from the side wall, and the measuring points of rooms over 30m2 are 1m away from the wall Test standard: (1) code for design of clean workshop (GB50073-2001) (2) technical code for building of clean operation Department of hospital (GB 50333-2002 (3) technical code for building of biosafety laboratory (GB 50346-2004 (4) code for construction and acceptance of clean room (GB 50591-2010) (5) Test method for suspended particles in clean room (area) of pharmaceutical industry GB / T 16292-2010 (6) test method for floating bacteria in clean room (area) of pharmaceutical industry GB / T 16293-2010 (7) test method for settling bacteria in clean room (area) of pharmaceutical industry GB / T 16294-2010