標(biāo)題: Titlebook: Containment Technology; Progress in the Phar Hans-Jürgen B?ssler,Frank Lehmann Book 2013 Springer-Verlag Berlin Heidelberg 2013 Electron Be [打印本頁(yè)] 作者: grateful 時(shí)間: 2025-3-21 16:53
書(shū)目名稱(chēng)Containment Technology影響因子(影響力)
作者: mortuary 時(shí)間: 2025-3-21 23:15
icture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.978-3-662-51052-0978-3-642-39292-4作者: Macronutrients 時(shí)間: 2025-3-22 00:45 作者: tinnitus 時(shí)間: 2025-3-22 04:56
https://doi.org/10.1007/978-3-662-36298-3 active ingredients in the form of dust particles of different sizes can‘t escape and do not reach the skin and respiratory tract of the operators and the surrounding room. If there are minor leaks, the concentration of the hazardous substances is markedly reduced.作者: cardiac-arrest 時(shí)間: 2025-3-22 09:00
Rhizomorpha (Dematophora) necatrix n. sp,7 Annex C to see. Robots are nowadays used in pharmaceutical isolators or cRABS for filling and sealing of vials and syringes only sporadically but, in the future there will be more solutions based on robots [1].作者: 慷慨不好 時(shí)間: 2025-3-22 15:58
https://doi.org/10.1007/978-3-662-38073-4anced technology options. Due to the strict physical separation of process and product on the one hand and the operator on the other hand, many atmospheric conditions are created and maintained. As an example, very low O. concentrations or low humidity for the processing of oxygen-sensitive or moisture-sensitive products are mentioned.作者: 慷慨不好 時(shí)間: 2025-3-22 18:58 作者: 馬具 時(shí)間: 2025-3-23 01:14
Access Devices,7 Annex C to see. Robots are nowadays used in pharmaceutical isolators or cRABS for filling and sealing of vials and syringes only sporadically but, in the future there will be more solutions based on robots [1].作者: 關(guān)節(jié)炎 時(shí)間: 2025-3-23 03:19 作者: 暴露他抗議 時(shí)間: 2025-3-23 08:38 作者: PSA-velocity 時(shí)間: 2025-3-23 13:00
Introduction/Definition,y features and operating costs savings versus conventional clean room approaches are driving the change to containment solutions. Containments can be glove boxes, isolators, or restricted access barrier systems (RABS) . Isolators have captured a firm position in the pharmaceutical industry during the past few years.作者: 容易懂得 時(shí)間: 2025-3-23 14:20
nt provides information useful for technology transfer.IncluThis book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced.?This book is a key publication to planning engineers, production managers and those interested in getting a p作者: Foment 時(shí)間: 2025-3-23 21:49 作者: 創(chuàng)新 時(shí)間: 2025-3-24 01:56
Rhizomorpha (Dematophora) necatrix n. sp, defined by the OEL level (Operators Exposure Level) of the material, the amount of dust created in the process and the SAL (Sterility Assurance Level), which has to be achieved for the product and the process作者: 薄荷醇 時(shí)間: 2025-3-24 05:15
Unkr?uter im Ackerbau der Neuzeitof pollution. Avoiding cross-contamination, material carryover and the protection of the environment and the operators are essential aspects of a thorough cleaning. Isolators with complex internal installations can be a problem for the user in this regard.作者: cauda-equina 時(shí)間: 2025-3-24 07:10
https://doi.org/10.1007/978-3-662-36303-4chieved for successful steam sterilisation, must be fumigated with a decontamination procedure, which makes the surfaces in the work area free of living organisms. It must be demonstrated a germ reduction of 6 log-levels with a suitable biological indicator.作者: MELON 時(shí)間: 2025-3-24 13:13
https://doi.org/10.1007/978-3-662-38071-0written in construction plans and specifications, according to which the isolator system is built. In the last section of the isolator construction these documents are consulted again to illustrate in the qualification, that there is a ready-made system that meets the customer requirements.作者: 從屬 時(shí)間: 2025-3-24 16:07
Product Protection Isolators,cular contamination. There are several methods with different levels of protection, starting from simple laminar flow units with PVC curtains up to open or closed Restricted Access Barrier System(RABS) and barrier isolator technology.作者: Atheroma 時(shí)間: 2025-3-24 20:47
Safe Change Filter Systems for Isolators, Containments, and RABS, defined by the OEL level (Operators Exposure Level) of the material, the amount of dust created in the process and the SAL (Sterility Assurance Level), which has to be achieved for the product and the process作者: 精美食品 時(shí)間: 2025-3-25 01:10 作者: 一美元 時(shí)間: 2025-3-25 05:37 作者: 頂點(diǎn) 時(shí)間: 2025-3-25 07:56
System Validation,written in construction plans and specifications, according to which the isolator system is built. In the last section of the isolator construction these documents are consulted again to illustrate in the qualification, that there is a ready-made system that meets the customer requirements.作者: 中止 時(shí)間: 2025-3-25 11:58
,Abwehrma?nahmen gegen Unkr?uter, like product protection, operator, and environment protection or a combination of both. As important as the transfer in the containment, is the transfer out of the containment. The transfer can either be continuous or batch wise. Figure?. shows the different transfer devices typically used with isolators for aseptic processes.作者: Nuance 時(shí)間: 2025-3-25 19:31
Introduction/Definition,ot be imagined without. Since its beginnings in the nuclear industry, many isolator applications are new to the chemical and pharmaceutical industries and are used to separate the user, product, and environment consistently from each other. For the pharmaceutical industry of the twenty-first century作者: 郊外 時(shí)間: 2025-3-25 23:29
Isolators for Personnel- and Environmental Protection,ed hazardous for operators. Full protective suits have the disadvantage that they are expensive in purchase and reconditioning, and time-consuming changes for the operator are necessary. Furthermore, the environment cannot be effectively protected from the release of problematic chemicals. The prote作者: Aggressive 時(shí)間: 2025-3-26 02:24 作者: 觀點(diǎn) 時(shí)間: 2025-3-26 07:16
Safe Change Filter Systems for Isolators, Containments, and RABS,o filter the exhaust air for the aeration of containments. The design and the efficiency of the filter system depends highly on the targets, which are defined by the OEL level (Operators Exposure Level) of the material, the amount of dust created in the process and the SAL (Sterility Assurance Level作者: 血友病 時(shí)間: 2025-3-26 11:17 作者: Paradox 時(shí)間: 2025-3-26 14:22
Aseptic Transfer Systems Into and Out of Barrier Isolators and RABS,sfer of goods and tools in and out of containment is an important process step and a critical procedure in the containment technology. During the past years a lot of efforts have been made from the industry to improve and develop transfer systems into containment isolators for different applications作者: FECT 時(shí)間: 2025-3-26 17:44 作者: 織布機(jī) 時(shí)間: 2025-3-26 22:14
Decontamination of Aseptically Operated Isolators,. Here is the method of choice the heat sterilization with steam (SIP). All plant parts or accessories which do not withstand the temperatures to be achieved for successful steam sterilisation, must be fumigated with a decontamination procedure, which makes the surfaces in the work area free of livi作者: CURB 時(shí)間: 2025-3-27 03:11
Monitoring of the Process Environment, of the aseptic manufacturing environment. Over a longer period of time, (trends) a consistent monitoring program allows to detect changes in the status “free of germs” of the isolator. The monitoring of the isolator helps to identify possible routes of contamination quickly and allows taking approp作者: 考得 時(shí)間: 2025-3-27 08:12 作者: 無(wú)價(jià)值 時(shí)間: 2025-3-27 13:27
Technological Outlook,y, which is also reflected in the dimensions and capacity of the isolator units required for fill-finish production steps. These products usually react very sensitive to external influences and cannot be terminally sterilized, therefore an aseptic preparation method with controlled environment is re作者: ascend 時(shí)間: 2025-3-27 14:09 作者: 等級(jí)的上升 時(shí)間: 2025-3-27 19:37 作者: 完成才會(huì)征服 時(shí)間: 2025-3-27 23:26 作者: 停止償付 時(shí)間: 2025-3-28 03:17
https://doi.org/10.1007/978-3-662-36298-3ed hazardous for operators. Full protective suits have the disadvantage that they are expensive in purchase and reconditioning, and time-consuming changes for the operator are necessary. Furthermore, the environment cannot be effectively protected from the release of problematic chemicals. The prote作者: Fierce 時(shí)間: 2025-3-28 06:36
https://doi.org/10.1007/978-3-662-36298-3 also the process like testing pharmaceutical samples for sterility or aseptic filling of vials and syringes can be protected from microbial and particular contamination. There are several methods with different levels of protection, starting from simple laminar flow units with PVC curtains up to op作者: BROTH 時(shí)間: 2025-3-28 12:16
Rhizomorpha (Dematophora) necatrix n. sp,o filter the exhaust air for the aeration of containments. The design and the efficiency of the filter system depends highly on the targets, which are defined by the OEL level (Operators Exposure Level) of the material, the amount of dust created in the process and the SAL (Sterility Assurance Level作者: jealousy 時(shí)間: 2025-3-28 16:40 作者: Infant 時(shí)間: 2025-3-28 21:52
,Abwehrma?nahmen gegen Unkr?uter,sfer of goods and tools in and out of containment is an important process step and a critical procedure in the containment technology. During the past years a lot of efforts have been made from the industry to improve and develop transfer systems into containment isolators for different applications作者: 疏忽 時(shí)間: 2025-3-29 02:08 作者: 急急忙忙 時(shí)間: 2025-3-29 04:51 作者: intertwine 時(shí)間: 2025-3-29 08:11 作者: 撤退 時(shí)間: 2025-3-29 12:09 作者: RENAL 時(shí)間: 2025-3-29 19:25
https://doi.org/10.1007/978-3-662-38073-4y, which is also reflected in the dimensions and capacity of the isolator units required for fill-finish production steps. These products usually react very sensitive to external influences and cannot be terminally sterilized, therefore an aseptic preparation method with controlled environment is re作者: capillaries 時(shí)間: 2025-3-29 19:44
Hans-Jürgen B?ssler,Frank LehmannProvides support material such as norms and guidelines.A complete reference for industrial engineers interested in isolator technology.Content provides information useful for technology transfer.Inclu
