Clean treatment technology in purification workshop
Clean treatment technology in purification pharmaceutical cleanroom
A high-risk operation area in the purification workshop, such as the filling area, the area where the rubber stopper barrel and the open packaging container in direct contact with the sterile preparation are placed, and the area for aseptic assembly or connection operation, should use one-way flow The operating station maintains the environmental status of the area; the one-way flow system in its working area...
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Clean treatment technology in purification workshop
A high-risk operation area in the purification pharmaceutical cleanroom, such as the filling area, the area where the rubber stopper barrel and the open packaging container in direct contact with the sterile preparation are placed, and the area for aseptic assembly or connection operation, should use one-way flow The operating table maintains the environmental state of the area; the one-way flow system must supply air evenly in its working area, and the wind speed is 0.36-0.54m/s. Or in a glove box, a lower wind speed can be used; Class B refers to the background area where the high-risk operations such as aseptic preparation and filling are located in the Class A clean area; Class C and D refer to the less important degree of aseptic production process Clean area for operating procedures. When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of suspended particles ≥ 5.0 μm in the long sampling tube of the remote sampling system.
The number of personnel in the clean area should be strictly controlled, and the staff should be regularly trained and assessed on basic knowledge of hygiene and microbiology, cleaning operations, etc., and the temporary foreign personnel entering the clean area should be guided and supervised; A buffer setting must be set up between the non-clean area and the people and logistics; no floor drain should be set up in the A-level clean area, and the operator should not operate with bare hands. When it is unavoidable, the hands should be disinfected in time; Equipment should not pass through lower-level areas; clean work clothes in areas above D-level should be washed, dried, and sorted in the clean area, and sterilized as required if necessary; sanitary tools that are free of shedding, easy to clean and easy to disinfect should be used in the clean area , Sanitary tools should be stored in a designated place that does not cause pollution to the product, and the use area should be limited; the number of dust particles, planktonic bacteria or settled bacteria detected in the clean room under static conditions must meet the regulations, and the dynamic conditions should be regularly monitored. clean state; the air purification system should be cleaned, repaired, maintained and recorded as required. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and clean rooms.
The air treatment measures for purifying the air conditioning system mainly include: air filtration, using the filter to effectively control the cleanliness of all the air introduced from the outside into the room, because the bacteria are attached to the suspended particles, while the particles are filtered, the bacteria can also Filter out; organize air flow to discharge pollutants, organize specific forms and strengths of air flow indoors, and use clean air to remove pollutants that occur in production; increase air static pressure to prevent outside polluted air from entering the room from doors and various leaks; Take comprehensive purification measures and take corresponding measures in process, equipment, decoration and piping.
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