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  • 控制GMP洁净车间污染的方法
    来源:http://www.jnyhrs.com 浏览: 发布日期:2021-12-16
    一、合理布置空间面积
    1、 Reasonably arrange the space area
    合理布局首先要理顺工艺流程,避免迂回往返。工作室的平面空间应合理,既有利于操作,又便于维修,不应预留闲置面积和空间。合理的空间与面积,也有利于合理的分区,防止混杂事故。 应该引起注意的是:GMP净化车间并非越大越好,面积和空间的大小关系着送风量的多少,决定着空调能耗的大小,影响工程的投资。但净化车间的空间面积也不可太小,太小可能不便于操作、维修。所以,设计合理的空间面积应考虑到设备操作、维修的需要。生产区和储存区应有与生产规模相适应的空间面积,用以安置设备、物料,便于操作和维修。一般净化车间高度控制在2.60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。车间内部应设有物料的中间站,其面积足以存放物料、中间产品、待验品和成品,且便于明确分区,大限度地减少差错和交叉污染.
    Reasonable layout should first straighten out the process flow and avoid detours. The plane space of the studio shall be reasonable, which is not only conducive to operation, but also convenient for maintenance. No idle area and space shall be reserved. Reasonable space and area are also conducive to reasonable zoning and prevent mixed accidents. It should be noted that the larger the GMP purification workshop is, the better. The size of area and space is related to the air supply volume, determines the energy consumption of air conditioning, and affects the investment of the project. However, the space area of the purification workshop should not be too small, which may be inconvenient for operation and maintenance. Therefore, the needs of equipment operation and maintenance should be considered in the design of reasonable space area. The production area and storage area shall have a space area suitable for the production scale to place equipment and materials for easy operation and maintenance. Generally, the height of the purification workshop is controlled at 2.60M, and individual high equipment can be raised locally, rather than comprehensively raising the height of the clean area. There shall be an intermediate station for materials in the workshop, which is large enough to store materials, intermediate products, products to be inspected and finished products, and is easy to clearly divide the area, so as to reduce errors and cross pollution to a great extent
    二、提高设备水平
    2、 Improve equipment level
    设备的材质、加工精度、密闭程度以及管理制度都与交叉污染有关。所以除了合理布局外,提高设备的自动化水平和组成联动的生产线,以减少操作人员,降低人员的活动频率,是防止交叉污染的必要措施。
    The material, processing accuracy, sealing degree and management system of the equipment are related to cross pollution. Therefore, in addition to reasonable layout, improving the automation level of equipment and forming a linkage production line to reduce operators and reduce personnel activity frequency are necessary measures to prevent cross pollution.
    固体制剂车间产尘量较大。如何防止固体制剂车间发生交叉污染呢?首先,选购的设备应有防护罩及携带有除尘装置;其次,要采取隔离措施,将其分成操作室和前室或操作室和辅机室。前室在平面布置上一般采用单机单室,辅机室可设在非洁净区,检修门设在走廊一侧。如压片、自动包衣、胶囊分装等设备可采用此类分隔方法。对于有些不带除尘辅机设备又不密封的单机,如粉碎机、粉剂或颗粒包装机,则可把隔离区内的排风经过滤后再送回隔离区,即形成自循环。
    The dust production of solid preparation workshop is large. How to prevent cross contamination in solid preparation workshop? First of all, the purchased equipment shall be equipped with protective cover and dust removal device; Secondly, isolation measures shall be taken to divide it into operation room and front room or operation room and auxiliary room. The front room generally adopts a single machine room in the plane layout, the auxiliary room can be set in the non clean area, and the access door can be set at one side of the corridor. Such separation methods can be used for tablet pressing, automatic coating, capsule sub packaging and other equipment. For some single machines without dust removal auxiliary equipment and without sealing, such as pulverizer, powder or particle packaging machine, the exhaust air in the isolation area can be filtered and then returned to the isolation area to form self circulation.
    实验室装修
    在生产过程中,有些药品引湿性强,当要求空气相对湿度低于50%甚至45%时,冷冻除湿很难达到要求。在许多除湿措施中,氯化锂转轮除湿较适用。除湿机可装在有特殊除湿要求的GMP净化车间,以净化的空气作为该岗位低湿的保护性空气,自成一个循环系统。
    In the production process, some drugs have strong moisture absorption. When the air relative humidity is required to be lower than 50% or even 45%, it is difficult to meet the requirements for freeze dehumidification. Among many dehumidification measures, lithium chloride runner dehumidification is more suitable. The dehumidifier can be installed in the GMP purification workshop with special dehumidification requirements. The purified air is used as the low humidity protective air of the post to form a circulating system.
    三、分设空调净化系统
    3、 Separate air conditioning purification system
    净化车间的空调净化系统应根据不同的洁净度等级分设。对β-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,其排风口应安装过滤设备,以将这些药物的污染降至*低限度。对不同洁净度等级的净化车间,产生粉尘和有害气体的净化车间,被排介质毒性大的、有易燃易爆气体的岗位,应单独设局部排风系统。净化车间的排风口应有防倒灌装置。送风、回风和排风的启闭应有连锁装置。
    The air conditioning purification system of the purification workshop shall be set according to different cleanliness levels. yes β- The working rooms of lactams, contraceptives, hormones, highly toxic microorganisms, anti-tumor drugs, radioactive drugs, etc. shall be equipped with air conditioning and purification system, and its exhaust outlet shall be equipped with high-efficiency filtration equipment to reduce the pollution of these drugs to a minimum. For purification workshops with different cleanliness levels, purification workshops that produce dust and harmful gases, and posts with highly toxic discharged media and flammable and explosive gases, a separate local exhaust system shall be set up. The air outlet of the purification workshop shall be equipped with anti backflow device. The opening and closing of supply air, return air and exhaust air shall be equipped with interlocking devices.
    四、严格控制人流物流
    4、 Strictly control the flow of people and logistics
    GMP净化车间应设专用的人流、物流通道。人员应按规定的净化程序进入,并应严格控制人数。对于物料可在除去浮尘后拆去外包通过缓冲间或传递柜送入。不同洁净等级的洁净区物品则通过传递窗传送。中间站宜设在位置,以便缩短运送距离。洁净区内不设与本岗位无关的管道。充分利用上下或周围的技术夹层,所有公用管道、工艺管道的主干管均在技术夹层安装。穿越地面、隔墙的管道尽可能靠近使用点并敷设套管,套管内的管道不应有焊缝,管道与套管之间应有可叉的密封措施。进入净化车间的管道应为不锈钢材质。
    The GMP purification workshop shall be equipped with special pedestrian and logistics channels. Personnel shall enter according to the specified purification procedures, and the number of personnel shall be strictly controlled. The materials can be removed after removing the floating dust and sent through the buffer room or transfer cabinet. The articles in the clean area with different cleaning levels are transmitted through the transfer window. The intermediate station should be set at the center to shorten the transportation distance. No pipeline irrelevant to the post shall be set in the clean area. Make full use of the upper, lower or surrounding technical interlayer, and the main pipes of all public pipelines and process pipelines are installed in the technical interlayer. Pipelines crossing the ground and partition wall shall be as close as possible to the use point and laid with casing. The pipeline in the casing shall not have welds, and forkable sealing measures shall be taken between the pipeline and the casing. The pipes entering the purification workshop shall be made of stainless steel.