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All hoses should have unique identifying designations for usage and cleaning documentation/tracking purposes. Hose usage and location should be well managed including how and where hoses are stored when cleaned, or when dirty and awaiting re-cleaning. Clean and dirty hold times and their derivation/validation should be documented and available. Properly stored and reused water hoses are acceptable, but they should be hung in an upside down “U” orientation for draining and located very near the outlets where they are used, but not touching the wall or floor, and away from any process splattering. They should not be left connected to their outlets after use unless they are to be reused within minutes. There should not be more than a single hose intended for use at any given water outlet so water samplers know which hose to use for sampling. 所有软管均应具有唯一的识别标记，以供使用和清洁记录/跟踪之用。软管的使用和位置应得到妥善管理，包括在清洁时、脏污时或等待再清洁时如何存放软管以及存放在何处。清洁后和脏污时的放置时间及其推导/验证应记录在案，并可供查阅。正确存放和重复使用的输水软管是可以接受的，但应以倒置的“U”形悬挂，以进行排水，并且应非常靠近其使用的出水口，但不能接触墙壁或地面，并远离任何工艺飞溅物。使用后，除非会在几分钟内重新使用，否则不应将其连接在出水口上。在任何给定的出水口，预期使用的软管不得超过一个，以便水取样员知道要使用哪个软管进行取样。 The handling of hose-end gaskets for reused hoses is an issue that has less defined industry-standard practices, but the organization’s procedure needs to ensure hygienic handling during storage and placement. For example, bulk gasket storage in bins accessed unhygienically is a noteworthy poor practice that can lead to water or product contamination. 对于重复使用的软管，其管端垫圈的处理是一个行业标准实践定义较少的领域，但组织的程序需要确保在储存和放置过程中进行卫生的处理。例如，将散装垫圈储存在以不卫生方式取用的容器中，就是一种值得注意的不良做法，可能导致水或产品污染。 Cleaned, sanitized, or sterile hoses to be used at outlets should be packaged with or separate from their end-fitting gaskets and labeled indicating their condition (i.e., clean, sanitized, sterilized). Documentation of the cleaning and sanitization process, associated SOPs, and qualification of those processes should be available for review. Such “refreshed” hoses and gaskets should be packaged or otherwise protected from external contamination, but do not need to be hung in any particular orientation prior to use unless their process leaves them wet. 在出水口使用的已清洁、已消毒或无菌软管应与其端部连接件垫圈一起包装或分开包装，并贴有标签注明其状态（即：清洁、已消毒、已灭菌）。清洁和消毒过程的文件记录、相关SOP以及这些过程的确认应可供审查。此类“已更新”的软管和垫圈应进行包装或以其他方式保护以防外部污染，但除非其处理过程使它们保持湿润，否则在使用前无需以任何特定方向悬挂。 Typically no rationale or validation is required if the frequency of refreshing hoses is daily, every shift, or with every use; however, if the frequency is less than daily, there is an expectation that a documented rationale and validation for how often hoses are reused be provided. Alternatively, robust sampling data from the POU (i.e., end of hose) demonstrating compliance throughout the use period can be provided. An “as needed” frequency of hose replacement is not a best practice and it can be difficult to demonstrate good compliance with this approach. 如果更新软管的频率是每天、每班次或每次使用，通常不需要提供理由或验证；但是，如果频率低于每天一次，则需要提供关于软管重复使用频率的书面理由和验证。或者，可以提供来自使用点（即软管末端）的强有力的取样数据，证明在整个使用期间均符合要求。“按需”更换软管的频率不是最佳实践，并且很难证明采用此方法能保持良好的合规性。 |
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