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Purification engineering is a basic supporting industry with a wide range of applications. At present, it is applied in many industries such as electronic information, semiconductors, optoelectronics, precision manufacturing, medical and health, bioengineering, aerospace, automobile spraying, etc. According to the precision and dust-free requirements of the industry, the grade difference is also large.
Purification engineering is an engineering discipline that removes pollutants such as fine particles, harmful air and bacteria in the air within a certain space, and controls indoor temperature, cleanliness, pressure, airflow speed and airflow distribution, noise vibration harshness, lighting and static electricity within a certain demand range. No matter how the external air conditions change, the rooms specially designed by the purification engineering have the ability to maintain the cleanliness, temperature, humidity, pressure and other performance originally set.
Pharmaceutical clean room is divided into four areas of ABCD. Particles and microorganisms are the main control objects of pharmaceutical industry clean room and clean area, and their environmental temperature and humidity pressure difference, illumination and noise should also be specified.
Class A area: high-risk operation areas, such as filling area, the area where rubber stopper barrels, open ampoules and open vials are placed, and the sterile assembly line or connection operation area. Laminar flow console (hood) is usually used to maintain the environmental state of this area. The laminar flow system must supply air evenly in its working area, and the wind speed is 0.36-0.54m/s (the guiding value). There should be data to prove the state of laminar flow and it needs to be verified. One-way flow or lower wind speed can be used in closed isolated operation area or glove box.
Class B area: refers to the background area outside Class A area for high-risk operations such as aseptic preparation and filling.
Grade C and D areas: clean operation areas with low importance in the process of producing sterile drugs.
1.The sterile room should be equipped with a sterile operation room and a buffer room. The cleanliness of the sterile operation room should reach class 10000, and the indoor temperature should be kept at 20-24℃ and the humility should be kept at 45-60%. The cleanliness of the ultra-clean platform should reach class 100.
2. The sterile room should be kept clean, and it is forbidden to pile up sundries to prevent pollution. All sterilization equipment and culture media should be strictly prevented from being polluted, and the contaminated ones should be stopped using.
3. The sterile room should be sterilized and cleaned regularly with suitable disinfectant to ensure that the environment of the sterile room meets the requirements.
4. All instruments, plates and other items that need to be brought into the sterile room should be tightly wrapped and sterilized by appropriate methods.
5. Before entering the sterile room, workers must wash their hands with soap or disinfectant, and then change special overalls, shoes, hats, masks and gloves in the buffer room (or wipe the hands with 70% ethanol again) before entering the sterile room for operation.
6. Before using the sterile room, the ultraviolet lamp of the sterile room must be turned on for irradiation sterilization for more than 30 minutes, and at the same time, the ultra-clean table should be turned on for air blowing. After the operation, clean the sterile room in time, and then sterilize it with ultraviolet lamp for 20 minutes.
7. Before inspection, the outer package of the sample should be kept intact, and it should not be opened to prevent pollution. Before inspection, disinfect the outer surface with 70% alcohol cotton ball.
8. All objects with live bacteria must be disinfected before they can be washed under the tap. It is forbidden to pollute the sewer.
Purification engineering is a basic supporting industry with a wide range of applications. At present, it is applied in many industries such as electronic information, semiconductors, optoelectronics, precision manufacturing, medical and health, bioengineering, aerospace, automobile spraying, etc. According to the precision and dust-free requirements of the industry, the grade difference is also large.
Purification engineering is an engineering discipline that removes pollutants such as fine particles, harmful air and bacteria in the air within a certain space, and controls indoor temperature, cleanliness, pressure, airflow speed and airflow distribution, noise vibration harshness, lighting and static electricity within a certain demand range. No matter how the external air conditions change, the rooms specially designed by the purification engineering have the ability to maintain the cleanliness, temperature, humidity, pressure and other performance originally set.
Pharmaceutical clean room is divided into four areas of ABCD. Particles and microorganisms are the main control objects of pharmaceutical industry clean room and clean area, and their environmental temperature and humidity pressure difference, illumination and noise should also be specified.
Class A area: high-risk operation areas, such as filling area, the area where rubber stopper barrels, open ampoules and open vials are placed, and the sterile assembly line or connection operation area. Laminar flow console (hood) is usually used to maintain the environmental state of this area. The laminar flow system must supply air evenly in its working area, and the wind speed is 0.36-0.54m/s (the guiding value). There should be data to prove the state of laminar flow and it needs to be verified. One-way flow or lower wind speed can be used in closed isolated operation area or glove box.
Class B area: refers to the background area outside Class A area for high-risk operations such as aseptic preparation and filling.
Grade C and D areas: clean operation areas with low importance in the process of producing sterile drugs.
1.The sterile room should be equipped with a sterile operation room and a buffer room. The cleanliness of the sterile operation room should reach class 10000, and the indoor temperature should be kept at 20-24℃ and the humility should be kept at 45-60%. The cleanliness of the ultra-clean platform should reach class 100.
2. The sterile room should be kept clean, and it is forbidden to pile up sundries to prevent pollution. All sterilization equipment and culture media should be strictly prevented from being polluted, and the contaminated ones should be stopped using.
3. The sterile room should be sterilized and cleaned regularly with suitable disinfectant to ensure that the environment of the sterile room meets the requirements.
4. All instruments, plates and other items that need to be brought into the sterile room should be tightly wrapped and sterilized by appropriate methods.
5. Before entering the sterile room, workers must wash their hands with soap or disinfectant, and then change special overalls, shoes, hats, masks and gloves in the buffer room (or wipe the hands with 70% ethanol again) before entering the sterile room for operation.
6. Before using the sterile room, the ultraviolet lamp of the sterile room must be turned on for irradiation sterilization for more than 30 minutes, and at the same time, the ultra-clean table should be turned on for air blowing. After the operation, clean the sterile room in time, and then sterilize it with ultraviolet lamp for 20 minutes.
7. Before inspection, the outer package of the sample should be kept intact, and it should not be opened to prevent pollution. Before inspection, disinfect the outer surface with 70% alcohol cotton ball.
8. All objects with live bacteria must be disinfected before they can be washed under the tap. It is forbidden to pollute the sewer.
