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GMP净化车间的标准

来源:http://www.henganjh.cn │ 发表时间:2019-06-01 

  GMP车间标准
  GMP workshop standard
  生物制药企业GMP要求的目标是确保建立科学和严格的无菌药品生产环境中,过程,操作和管理系统,以消除所有可能的和潜在的生物活性,灰尘和pyrogenous污染比较大限度地生产高质量、卫生和安全的医药产品。生物制药净化工程的解决方案——GMP洁净厂工程和污染控制技术是保证GMP顺利实施的主要方法之一。通过对生物制药客户生产环境的深入研究和工程经验的积累,我们清楚地认识到控制生物制药生产过程环境的关键;节能是我们系统解决方案的重点;我们比较擅长为客户提供符合GMP、Fed 209D、ISO14644、IEST、EN1822的环保解决方案,并应用比较新的节能技术。从GMP全厂规划设计——人流物流净化方案、洁净空调系统、洁净装修系统;全厂节能改造、水电、超纯燃气管道、洁净室监控、维修系统等综合安装配套服务。
  The GMP requirements of biopharmaceutical companies are to ensure the establishment of scientific and rigorous aseptic drug production environment, processes, operations and management systems to eliminate all possible and potential biological activities, dust and pyrogenous pollution to maximize the production of high-quality, hygienic and safe medical products. GMP clean plant project and pollution control technology, the solution of biopharmaceutical purification project, are one of the main methods to ensure the smooth implementation of GMP. Through in-depth research on the production environment of biopharmaceutical customers and accumulation of Engineering experience, we clearly recognize the key to control the production environment of biopharmaceutical products; energy conservation is the focus of our system solutions; we are best at providing customers with environmentally friendly solutions in line with GMP, Fed 209D, ISO14644, IEST, EN1822, and applying the latest energy-saving technologies. From GMP plant planning and design - people flow logistics purification scheme, clean air conditioning system, clean decoration system; plant energy-saving transformation, hydropower, ultra-pure gas pipeline, clean room monitoring, maintenance system and other integrated installation supporting services.
  GMP净化车间卫生管理为了防止GMP车间内的交叉污染,应根据产品特点、工艺要求和不同的空气清洁度水平,专门使用清洁净化车间设施的工具。垃圾应放入防尘袋内并取出。GMP车间清洁必须在工作前和生产结束后进行;净化车间空调系统运行中应进行清洗;净化工作结束后,净化空调系统应继续运行,直至达到规定的清洁水平。启动和运行时间一般不小于GMP车间的自清洗时间。应定期更换消毒剂,防止微生物产生抗药性。进入车间的大型物体,首先要使用真空吸尘器在一般环境中对粉尘进行初步净化,然后进入净化车间,用洁净室的吸尘器或清洗方法进行进一步处理;GMP车间净化系统关闭期间,大型物体不得进入净化车间。
  In order to prevent cross-contamination in GMP workshop, hygiene management of GMP purification workshop should use special tools for cleaning workshop facilities according to product characteristics, process requirements and different levels of air cleanliness. Garbage should be put in a dustproof bag and taken out. The cleaning of GMP workshop must be carried out before and after work, the air-conditioning system of purification workshop should be cleaned during operation, and the air-conditioning system of purification workshop should continue to operate until the required cleaning level is reached. Start-up and operation time is generally not less than GMP workshop self-cleaning time. Disinfectants should be replaced regularly to prevent microorganisms from producing drug resistance. Large objects entering the workshop should first be cleaned by vacuum cleaner in general environment, then enter the purification workshop and further treated by cleaner or cleaning method in the clean room. During the closure of the purification system in GMP workshop, large objects are not allowed to enter the purification workshop.
                             gmp车间净化公司
  GMP车间进行消毒灭菌,可采用干热灭菌、湿热灭菌、辐射灭菌、气体灭菌、消毒剂消毒。本文介绍了辐射杀菌,主要适用于热敏性物质或产品的杀菌,但必须证明辐射对产品是无害的。紫外线消毒有一定的杀菌作用,但使用中存在许多问题,紫外线灯的强度,清洁,环境湿度和距离,和许多其他因素会影响消毒效果,及其杀菌效果不高,不适用于有人员活动空间和空气流动空间,这些原因使紫外线消毒不接受海外GMP。紫外线杀菌需要对暴露在外的物体进行长期照射。对于室内辐照,当灭菌率要求达到99%时,一般细菌的辐照剂量约为10000-30000uw。s /厘米。距离地面2m的15W紫外线灯,其照射强度约为8uw/cm,需要照射约1h,且在1h内不能进入照射部位,否则会损伤人体皮肤细胞,具有明显的致癌作用。
  GMP workshop can be sterilized by dry heat, wet heat, radiation, gas and disinfectant. In this paper, radiation sterilization is introduced. It is mainly suitable for sterilization of thermosensitive substances or products, but it must be proved that radiation is harmless to products. Ultraviolet disinfection has a certain bactericidal effect, but there are many problems in use. The intensity, cleanliness, environmental humidity and distance of ultraviolet lamp, and many other factors will affect the disinfection effect, and its bactericidal effect is not high. It is not suitable for people's living space and air flowing space. These reasons make ultraviolet disinfection unacceptable to overseas GMP. Ultraviolet sterilization requires long-term irradiation of exposed objects. For indoor irradiation, when the sterilization rate is 99%, the irradiation dose of general bacteria is about 10 000-30 000 uw. S / cm. The radiation intensity of 15W ultraviolet lamp 2 m away from the ground is about 8 uw/cm. It needs to be irradiated for about 1 hour, and it can not enter the irradiation site within 1 hour. Otherwise, it will damage human skin cells and have obvious carcinogenic effect.
  恒安机械是一家集研发、生产、销售、工程施工、技术服务为一体的高新技术企业,公司产品规格齐全,主要产品系列有:彩钢材料系列、聚苯乙烯保温材料系列和通风降温产品三大系列。公司拥有先进的进口设备,全自动连续生产线,产品性能、质量均处于世界先进水平,非常好地满足了市场的需求。
  Heng'an Machinery is a high-tech enterprise integrating R&D, production, sales, engineering construction and technical services. The company has complete product specifications. Its main product series are: color steel material series, polystyrene insulation material series and ventilation cooling products series. The company has advanced imported equipment, automatic continuous production line, product performance and quality are in the world's advanced level, very good to meet the needs of the market.
  公司严格遵守ISO9001质量体系,产品通过国家权威检测机构,满足市场安全要求。
  The company strictly abides by the quality system of ISO 9001, and the products meet the market safety requirements through the authoritative testing institutions of the state.
  每一个环节、每一步都体现了恒安人的专业性和创新性,严格控制质量,始终关注客户的需求,努力打造世界一流的企业。
  Every link and step embodies the professionalism and innovation of Heng'an people, strictly control the quality, always pay attention to the needs of customers, and strive to build a world-class enterprise.
  我们愿意共同努力,创造更好的生活环境,为社会做出贡献。
  We are willing to work together to create a better living environment and contribute to society.
 

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