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How do clean rooms prevent cross contamination?

日期:2020-07-06 17:06
浏览次数:21
摘要:How do clean rooms prevent cross contamination? The clean workshop design specification implemented in 2002 clearly states that "the technological plane layout of the clean workshop should be reasonable and compact. The clean room or clean area shall be equipped with only the necessary process equipment and procedures and workshops with air cleanliness requirements. ■ improve equipment level The material, processing accuracy, airtightness and management system of th..
How do clean rooms prevent cross contamination? The clean workshop design specification implemented in 2002 clearly states that "the technological plane layout of the clean workshop should be reasonable and compact. The clean room or clean area shall be equipped with only the necessary process equipment and procedures and workshops with air cleanliness requirements.





■ improve equipment level



The material, processing accuracy, airtightness and management system of the equipment are all related to cross contamination. Therefore, in addition to rational layout, it is necessary to improve the automation level of equipment and form a linkage production line to reduce operators and the activity frequency of personnel. Solid preparation workshop produces large amount of dust. How to prevent cross contamination in solid preparation workshop? First of all, the selected equipment should have a protective cover and carry dust removal device; Next, should adopt segregation measure, divide it into operation room and front room or operation room and auxiliary engine room. The front room is generally single room on the plane layout, auxiliary room can be located in the non-clean area, access door in the corridor side. Such separation method can be used for such equipment as tablet pressing, automatic coating and capsule subassembly. For some do not have dust removal auxiliary equipment and do not seal the single machine, such as crusher, powder or particle packaging machine, can put the exhaust air in the isolation area after filtering back to the isolation area, that is, the formation of self-circulation. In the production process, some drugs have strong hygroscopicity. When the relative humidity of air is lower than 50% or even 45%, it is difficult to meet the requirements of refrigeration dehumidification. In many dehumidification measures, lithium chloride wheel dehumidification is more suitable. The dehumidifier can be installed in a clean room with special dehumidification requirements, with the purified air as the protection air of low humidity for this position, it can form a circulation system of its own.





■ separate air-conditioning purification system



The air conditioning purification system of the clean room should be set up according to different cleanliness levels. For the studios of beta-lactamides, contraceptives, hormones, virulent microorganisms and anti-tumor drugs, radioactive drugs, etc., air conditioning purification system should be set up, and the air outlet should be installed with filtration equipment, so as to reduce the pollution of these drugs to a minimum. For clean rooms with different cleanliness levels, clean rooms producing dust and harmful gases, and posts with highly toxic exhaust media and inflammable and explosive gases, local exhaust system should be set up separately. The air outlet of clean room should have anti - reverse irrigation device. The opening and closing of air supply, return air and exhaust air shall be interlocked.





Strictly control the flow of people and logistics



The clean room should be equipped with dedicated people flow and logistics channels. Personnel shall be admitted in accordance with the prescribed purification procedures and the number shall be strictly controlled. Materials can be removed from the outside after dust removal and sent in through buffer or transfer cabinet. Clean area items of different cleanliness levels are transported through the transfer window. The intermediate station should be centrally located to shorten the distance. There are no pipes unrelated to the post in the clean area. Make full use of the technical interlayer above and below or around, all the main pipes of the public pipelines and process pipelines are installed in the technical interlayer. The pipe that crosses the ground and the partition wall should be close to the point of use as far as possible, and the casing should be laid. There should be no welding seam in the pipe inside the casing, and there should be a forkable sealing measure between the pipe and the casing. Piping into the clean room shall be stainless steel.



■ reasonable arrangement of space area



Reasonable layout should first straighten out the process flow, avoid roundtrip. The floor space of the studio should be reasonable, which is convenient for operation and maintenance, and should not reserve idle area and space. Reasonable space and area are also conducive to reasonable zoning and prevent mixed accidents.