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Tablet clean room 10,000-300,000 clean area process hygiene management, including HVAC system, purified water system, drinking water system; clean plant environmental sanitation; equipment, container, production tool hygiene requirements; material hygiene; production process hygiene project.
The clean room management system of the clean room in the clean room will ensure that the health projects involved in the clean room cleaning process are well implemented and maintained, ensuring that the clean area will not cause pollution and cross-contamination due to poor process hygiene. The weight of it.
1. Definition Distinction
Process hygiene: Hygienic requirements for all materials, production processes and equipment used.
Contamination: An object or substance that is treated as a substance, due to adhesion, mixing or production of a substance, its performance and function can adversely affect the process or cause it to be adversely affected, becoming a pollution. The popular saying is that when something comes into contact with or is mixed with unclean or spoiled material, making the substance impure or unsuitable, it is contaminated.
Cross-contamination: In production, one raw material, intermediate product or finished product is contaminated by another raw material or product.
2. Hygienic requirements for purified water system in clean room of clean room
The purified water prepared by the purified water system is the medium for direct contact with the drug in the production of the product. The water quality standard should meet the standard requirements, and the microbial project should not exceed the set warning limit; the purified water system is divided into routine monitoring and water quality monitoring. Part. Routine monitoring refers to the operation of the purified water system operators in the daily operation of the system to monitor the operation of the various processing units and processing capacity; water quality monitoring refers to the pure water system in the daily operation process The QC department samples the pure water tank, the total water supply port, the total water return and each point of use according to the predetermined sampling plan, and tests the chemical project and the microbial project to evaluate that the water system should be qualified under normal operating conditions. Pure water.
The pre-washing water used in the cleaning process of drinking water system as equipment, container, production tool, cleaning tool, etc. in the clean area shall meet the requirements of drinking water standard; the sanitary monitoring of drinking water involves a large number of testing items. It is regularly monitored by a qualified health and epidemic prevention department and a report is issued.
3. Requirements for clean room environmental sanitation in clean room of tablet clean room
The clean area should establish the “cleaning and disinfection regulations for clean workshops” to ensure that the clean workshops are always in good sanitary condition; the clean floor, walls, ceilings, doors and windows, operation consoles, various pipes, lamps, tuyères and other public facilities, walls The junction with the ground should be kept clean and free of dust. Clean floor drains should be clean, regularly cleaned and disinfected, and always kept in a liquid-sealed condition. Facilities such as sinks and tool cleaning pools should be cleaned and disinfected regularly to keep them clean and free of dust, dirt and water. Buffer facilities such as buffer rooms and transfer windows cannot be opened at the same time at any time. The doors on both sides of the transfer window should have interlocking devices.
All kinds of utensils, containers, equipment, tools, tables, chairs, cleaning tools, etc. used in the clean area should be made of non-shedding materials, easy to clean, easy to disinfect, no rust, no mold, and should not be used, bamboo, wood, Ceramic, iron and other materials. It is not advisable to use racks, cabinets and equipment that are not easy to clean, sag or protrude. Clean and disinfect the cleaning tools after use. For cloth materials and dry in time, place them in the specified position in a well-ventilated sanitary ware cleaning room. Before use, check if the mop and rag will fall off the fiber after use. Disinfectants used in the clean area should be used alternately to prevent the emergence of resistant strains in the clean area. Wastes in the production process should be promptly placed in clean and dust-free containers or bags, sealed at designated locations, and cleaned out at the end of production. The bag should be disposable.
4. Process hygiene implementation and monitoring
The process hygiene in the clean area shall be strictly carried out and recorded by the corresponding personnel in accordance with the relevant procedures, and shall ensure that it is always in a good sanitary state; the quality and health monitoring shall be supervised by the quality personnel and QC monitoring personnel according to their respective duties. Environmental monitoring to assess the status of health implementation; managers at all levels of the clean area should be responsible for the supervision and inspection of the implementation of the process, and should ensure the correct implementation; the quality department supervises and inspects the process hygiene of the clean area.
The dedicated camera in the clean area is a special network camera specially developed for the clean area/clean room/clean room of the pharmaceutical factory, electronics factory, hospital operating room, food factory, etc. for the special use environment of clean area and clean room. The camera can be seamlessly embedded in the color steel plate installation, the flat round outer surface is flush with the color steel plate, no sanitary corners, easy to clean and easy to disinfect. The camera provides 24-hour fixed-point monitoring of key processes and key positions. The camera can be used in conjunction with the Weiyuan Tektronix OPCMES software to achieve clean zone monitoring and alarm events associated with video clips.
As a production place for pharmaceutical companies, the clean area has strict regulations and requirements for the environment, dress and personnel flow. The operation of the clean room personnel cannot be fully monitored by a single hemispherical camera, and it is impossible to perform real-time fixed-point monitoring of the operation status and operation process of important equipment. How to realize the fixed-point real-time monitoring of key off-site and key equipment in the clean area?
In order to achieve multi-point monitoring between clean room operations, it is necessary to increase the number of surveillance cameras in the clean room under the current technical conditions. The hemispherical camera is mounted on the ceiling, the installation position is too high, the cleaning is inconvenient, and there is a sanitary corner, which increases the workload of cleaning and acceptance of the clean room.
The embedded dedicated camera in the clean area solves this problem. The embedded special camera in the clean area is installed on the color steel plate wall of the clean area, and is installed by inserting the color steel plate. The installation height is about 40-60cm from the ceiling. The plane of the camera is a pure flat plate. After being embedded in the color steel plate, the plane of the camera is flush with the plane of the color steel plate, and the cleaning of the camera is realized while cleaning the wall surface with a wall wipe. At the same time, the flat panel of the camera has zero sanitary corners, and there is no situation where the cleaning is not in place.
5. Requirements for the hygiene management of production equipment in the dust-free workshop of the clean room of tablets
Hygienic requirements for equipment, containers, production tools
After each production stage, the equipment, containers, and production tools must be cleaned according to standard operating procedures to wash away the previous batch of residue. The final rinse water must be purified water. Certain types of equipment that are difficult to clean can be dedicated to a specific intermediate product, the production or storage of the drug substance, but should be thoroughly cleaned on a regular basis. Clean the dust in the dust collector, piping system and dust collector as required by the standard operating procedures. Be careful to avoid dust and dust.
The materials put into production must meet the quality standards and have the certificate of conformity; the packaging requirements are intact, no moisture, deterioration, mold, insects, rat bites, etc. When the materials enter the cleanliness, they should be strictly in accordance with the control procedures of the materials entering and leaving the 300,000-level clean area, and should be stored. The drying air that is in direct contact with the drug, the compressed air should be purified and meet the production requirements, and the quality should be regularly monitored according to the regulations to meet the corresponding production requirements. When materials and intermediate products flow in the clean area, they should be marked with obvious marks and containers to prevent pollution.
Production process hygiene
All positions, containers, tools, floor drains, changing rooms, buffer rooms, equipment, etc. in the clean area shall be cleaned or disinfected according to the corresponding sanitary cleaning procedures; all materials such as materials, containers and production tools shall be subject to fixed management. Keep a good production order in the production process. According to the state identification management regulations, the health status signs should be provided for each operation room, equipment, container, etc. According to the clearing management system, after the end of production at each production stage, the clearing shall be carried out according to the regulations. Strict control of the number of people entering the clean room is limited to the production operators and approved personnel in the area; the doors of the operating room should be closed during work and the number of visits should be minimized. Temporary outsiders should be guided and supervised. A registration system is implemented for personnel entering the clean room. When operating in a clean area, the action should be steady, light, and low, and do not perform actions that are not related to the operation and unnecessary conversation. No clean shifts can be arranged in three shifts. Allow enough time each day for cleaning or disinfection.