Use of Hoses in the Pharmaceutical Industry
制药行业使用的软管
Hoses are omnipresent in the production of medicinal products.
软管在医药产品的生产中是无处不在的。
Now, how to cope with hoses? What is state of the art? Are there practical references?
现在，如何处理软管？当前的技术水平如何？有无实用性的参考文献？
The general requirements on pipes and hoses are comparable: hoses - as well as the whole production equipment - have to be suitable and easy to clean. Besides, they shouldn't influence negatively the quality of the pharmaceutical product.
对管道和软管的一般要求是类似的：软管，连同整个生产设备，应该适合并易于清洁。另外，它们不应对药品质量产生不良影响。
Yet, compared to permanently installed pipes, hoses present a range of disadvantages - only visible at second glance. It begins with specifications: as well as for stainless steel, certificates must be available for hoses intended to come into contact with products and clean media. This is necessary to demonstrate that the hose material has no influence on the product. In Europe, the state of the art for stainless steel with regard to the material certificate is unambiguous: the gold standard is the certificate 3.1 according to DIN EN 10204. However, hoses are subject to a large collection of potential and common certificates. The use of a hose for pharmaceutical water requires for example a material listing according to FDA's 21 CFR 177.2600, the positive list of German Federal Institute for risk analysis or a listing under EC1935/2004 (Materials and articles intended to come into contact with food), EC2023/2006 (Good manufacturing practice for materials and articles intended to come into contact with food). Indeed, this is absolutely sufficient for many purified water hoses. A certificate according to USP Class VI or even the request for "ADI-free" (raw materials contain no Animal Derived Ingredients [ADI] and are therefore BSE / TSE free with respect to source, manufacture and treatment [BSE Bovine Spongiform Encephalopathy; TSE Transmissible Spongiform Encephalopathy]) is somewhat excessive in most applications regarding pharmaceutical water.
然而，与固定安装的管道相比，软管有一些缺点，细看才知道。首先是标准，与不锈钢一样，与产品和洁净介质接触的软管应有相关证书。有必要论证软管的材料不影响产品。在欧洲，对不锈钢材质证明的现行法规是比较明确的：黄金标准是DIN EN10204-3.1证书。而软管则有多个潜在的和通用的证明。例如，根据FDA 21 CFR 177.2600，德国联邦研究所允许进口清单或EC1935/2004（与食品接触的物料和物品）下的清单，EC2023/2006（与食品接触的物料和物品良好生产规范），制药用水使用的软管要求有一个物料清单。确实，这对于很多纯化水软管来说是绝对充分的。根据USP 认定为 VI级或甚者要求“不含ADI”（原料不含动物衍生成分）和来源、生产和处理过程无BSE / TSE（BSE：疯牛病；TSE：传染性海绵状脑病）的证明对于大多数在制药用水的应用来说有点过分。
Depending on the area of application, recurring pressure tests are necessary;
根据使用的区域，循环压力测试是必须的。
And this is just the beginning.
而这才仅仅是开始。
Hoses need to be qualified before use. In the course of qualification, some elements must be checked or determined such as cleaning, disinfection, sterilisation, intended purpose (single / multi-use), i.e. leach out, examination of the inner surface, particle release, durability, test procedure. Within the qualification procedure, the hold times also have to be determined:
软管在使用前需要被确认。在确认过程中，一些因素需要被检查或确定，例如清洁、消毒、预期用途（单独使用/多种用途），如浸出物、内表面、微粒释放、耐用性的检查，测试程序。在确认程序中，下列保持时间也需要被确定：
1.) Maximum time after use before cleaning/sanitising/sterilizing
使用后待清洁/消毒/灭菌的最长时间
2.) Maximum time allowed to have a hose in use (before re-treatment is needed).
允许使用软管的最长时间（需要再次处理之前）
3.) Maximum storage time before an hose has to be re-treated or replaced.
软管存放直到需要再处理或更换的最长时间
Hoses used in clean areas (from clean room class C included) have to be smooth both inside and outside to be easy to clean. Fabric hoses are thus excluded. Stainless steel overbraided hoses dedicated to clean steam are also critical with respect to cleanability.
洁净区域使用的软管（包括C级洁净室）应该内外表面光滑以易于清洁。因此夹布胶管是不允许使用的。考虑到洁净性，洁净蒸汽专用的不锈钢编织软管也很危险。
As for pipes, labelling obligation is required. Whereby, not only the medium is relevant but also the unambiguous labelling of each single hose. The status of the hose (with regard to its use, treatment status, age, lifetimes, see above) has thus to be clear identifiable before its use. In addition to their labelling, hoses have to be correctly stored and correctly locked.
对于管道，应该进行标识。不单单指介质，每条单独的管道都要清晰标识。这样，软管的状态（使用、处理状态，使用时长，使用期限，如上）在使用前就都能够被清晰辨识。除了标识之外，软管还需要被正确的存放以及正确的上锁。
The DIN 26055 "Hose assemblies for use in the pharmaceutical and biotechnological industry" from 2010 provides valuable support for the selection and correct utilisation.
2010版的DIN 26055《制药和生物技术行业使用的软管组件》对选择和正确使用软管提供了有价值的支持。
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发表于 2019-7-12 18:55:37
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