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How to prevent cross-contamination in clean rooms
的核心之一。 Preventing errors, pollution and cross-contamination is one of the core of GMP . Cross-contamination refers to the mixing of components of different types of drugs to cause contamination by means of personnel return, tool transportation, material transfer, air movement, equipment cleaning and disinfection, and job clearance, or due to inappropriate human, industrial appliances, materials, air, etc. The flow direction causes pollutants in areas with low cleanliness to flow into areas with high cleanliness, causing cross-contamination. So how do you prevent cross-contamination? 年实施的《洁净厂房设计规范》明确指出，洁净厂房“工艺平面布置应合理、紧凑。洁净室或洁净区内只布置必要的工艺设备以及有空气洁净度要求的工序和工作室”。 The "Clean Workshop Design Code" implemented in 2002 clearly stated that clean workshops should be "reasonably and compactly laid out in the process. Only necessary process equipment and processes and workshops with air cleanliness requirements should be arranged in the clean room or clean area."
A reasonable layout space area
Reasonable layout must first straighten out the process flow and avoid round trips. The flat space of the studio should be reasonable, which is convenient for operation and easy to maintain. No idle area and space should be reserved. Reasonable space and area are also conducive to reasonable zoning and prevent mixed accidents.
It should be noted that the larger the clean room is, the better. The size of the area and space is related to the amount of air supply. It determines the energy consumption of air conditioning and affects the investment of the project. However, the space area of the clean room should not be too small, too small may not be easy to operate and maintain. Therefore, the reasonable design of the space area should take into account the needs of equipment operation and maintenance. The production area and storage area should have a space area suitable for the production scale, which is used to house equipment and materials for easy operation and maintenance. 米，对个别较高的设备可在局部加高，而不宜全面提高洁净区的高度。 Generally, the height of the clean room is controlled at 2.60 meters, and individual higher equipment can be locally raised, and it is not appropriate to raise the height of the clean area in an all-round way. There should be an intermediate station for materials inside the workshop, which is large enough to store materials, intermediate products, products to be tested and finished products, and is convenient for clear division to minimize errors and cross-contamination.
Improve equipment level
The material, processing accuracy, tightness and management system of the equipment are all related to cross-contamination. Therefore, in addition to a reasonable layout, improving the automation level of the equipment and forming a linked production line to reduce the number of operators and the frequency of personnel activities are necessary measures to prevent cross-contamination.
The solid preparation workshop produces a large amount of dust. How to prevent cross-contamination in the solid preparation workshop? First, the purchased equipment should have a protective cover and carry a dust removal device. Second, isolation measures must be taken to divide it into an operating room and a front room or an operating room and an auxiliary machine room. The front room is generally arranged in a single machine and single room. The auxiliary machine room can be located in a non-clean area, and the maintenance door is located on the side of the corridor. Equipment such as tabletting, automatic coating, capsule dispensing, etc. can adopt this type of separation method. For some stand-alone machines without dust removal auxiliary equipment and not sealed, such as a pulverizer, powder or granule packaging machine, the exhaust air in the isolation zone can be filtered and sent back to the isolation zone to form a self-circulation.
％甚至 45 ％时，冷冻除湿很难达到要求。 In the production process, some medicines are highly hygroscopic. When the relative humidity of the air is required to be less than 50 % or even 45 %, freezing and dehumidification are difficult to meet the requirements. Among many dehumidification measures, lithium chloride rotor dehumidification is more suitable. The dehumidifier can be installed in a clean room with special dehumidification requirements. The purified air is used as the low-humidity protective air for the post and forms a self-circulating system.
Three air conditioning purification systems
The air-conditioning purification system of the clean room should be divided according to different cleanliness levels. 内酰胺类、避孕药品、激素类、强毒微生物及抗肿瘤药品、放射性药品等的工作室，应设置空调净化系统，其排风口应安装高效过滤设备，以将这些药物的污染降至最低限度。 Air-conditioning purification systems should be installed in the studios of β - lactams, contraceptives, hormones, strong toxic microorganisms, anti-tumor drugs, radiopharmaceuticals, etc. The exhaust outlets should be installed with high-efficiency filtering equipment to contaminate these drugs To a minimum. For clean rooms with different levels of cleanliness, clean rooms that generate dust and harmful gases, posts with high toxicity of flammable media and flammable and explosive gases shall be provided with separate exhaust systems. The exhaust outlet of the clean room should have anti-irrigation device. The opening and closing of the supply air, return air and exhaust air shall have interlocking devices.
Strictly control the flow of people and logistics
The clean room should be provided with a dedicated flow of people and logistics. Personnel shall enter in accordance with the prescribed purification procedures, and the number of persons shall be strictly controlled. After removing the dust, the materials can be removed and sent out through the buffer room or transfer cabinet. Items in different cleanliness areas are transferred through the transfer window. Intermediate stations should be centrally located to reduce the transport distance. There are no pipes unrelated to this post in the clean area. Make full use of the upper and lower or surrounding technical interlayers, and the main pipes of all common pipes and process pipes are installed in the technical interlayers. Pipes that cross the ground and partition walls should be as close as possible to the point of use and the casing should be laid. There should be no welds in the pipeline in the casing, and there should be a fork-proof seal between the pipeline and the casing. The pipes entering the clean room should be stainless steel
Related links: Dongguan air-conditioning purification project, Dongguan dust-free purification equipment, Changan central air-conditioning project, low-voltage power distribution project, Dongguan purification ventilation project, Dongguan dust-free purification project, hydropower installation project, Dongguan 100,000-level dust-free workshop, Dongguan City Power Xiang Air Conditioning Purification Engineering Co., Ltd.
Article source: http://jimesale.com Tan Yuming 13751461639