Process hygiene control in clean workshop
Process hygiene control in clean workshop
The clean pharmaceutical cleanroom prevents the intrusion of pollution sources and makes the generated pollution sources quickly discharge out of the system without polluting the production environment. The air purification system can effectively solve the pollution of particles and microorganisms in the air. role, put more than 0.3μm...
Text label: clean workshop plant design, clean workshop construction, process hygiene control
Process hygiene control in clean pharmaceutical cleanroom
The clean workshop prevents the intrusion of pollution sources and makes the generated pollution sources quickly discharge out of the system without polluting the production environment. The air purification system can effectively solve the pollution of particles and microorganisms in the air. It can remove more than 99.97% of the particles above 0.3μm, purify the air entering the production area, and at the same time remove or take away the particles generated in the production process; The positive pressure in between can cut off the infiltration of external particles, and the negative pressure state can prevent the diffusion of process dust. The use of air showers, air locks or air curtains can effectively prevent polluted air from entering the operating room through the channel; when using the air purification system, It is necessary to prevent the unpurified air from participating in the recirculation, or to cause the polluted air to invade again and cause large-scale pollution due to inattentive exhaust; in order to avoid pollution to other products or other processes, it is necessary to install a filter when setting the exhaust system When the filter is disassembled and replaced, dust should be prevented from polluting the operating room.
There should be enough space in the building for storing materials, intermediate products, equipment, and utensils in an orderly manner. There must be compartments for operations that are prone to dust, and closed operations should be used as much as possible to prevent cross-contamination caused by dust flying. , such as weighing room, crushing room, mixing room, granulation room, tableting room, capsule filling room, etc. The lack of thorough cleaning of mechanical equipment and surrounding equipment is a common cause of cross-contamination. For sites and equipment with dust operations, When the batch production is over, clear out irrelevant materials and record sheets, and use a vacuum cleaner to absorb the dust on the surface. If possible, rinse the appliance with water or scrub with a damp cloth; in order to avoid the spread of pollution caused by dust flying, generally do not choose to use a broom To clean, avoid dust, and finally wash and disassemble the site equipment; in the preparation production pharmaceutical cleanroom, an equipment cleaning room is often attached, and most of the equipment that cannot be disassembled, such as the potting equipment of liquid preparations, is mostly cleaned online, and the equipment cleaning method must be verified. confirm. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean workshops and clean workshops.
The number of contaminating microorganisms in raw and auxiliary materials varies from several to 106 per gram. It is used in the production of sterilized preparations. First, the materials are checked and accepted according to the requirements of sterilized preparations, and the microbial contamination is eliminated by sterilization in the production of ingredients. Bacterial preparations, for raw and auxiliary materials with serious pollution, can be sterilized by moist heat or ethylene oxide first to control microorganisms to a minimum; drinking water, pure water and water for injection used in the process are generally used by manufacturers according to relevant regulations. The selection, preparation and use are stipulated. No matter what water is used, it should be noted that the residual water in the water supply channel is a place for microbial contamination and reproduction. The bacteria in the residual water released from the pipeline after 12 hours can increase in value by 103 times, so it must be turned on the faucet. The effluent water can only be used after a period of exile. Any raw and auxiliary materials and packaging materials in direct contact must be removed from the outer packaging before entering the production area to ensure the cleanliness of the production area.
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