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制藥用水系統(tǒng)-末端軟管的使用注意事項(xiàng)

 留在家里 2025-07-06 發(fā)布于浙江

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.

所有軟管均應(yīng)具有唯一的識(shí)別標(biāo)記,以供使用和清潔記錄/跟蹤之用。軟管的使用和位置應(yīng)得到妥善管理,包括在清潔時(shí)、臟污時(shí)或等待再清潔時(shí)如何存放軟管以及存放在何處。清潔后和臟污時(shí)的放置時(shí)間及其推導(dǎo)/驗(yàn)證應(yīng)記錄在案,并可供查閱。正確存放和重復(fù)使用的輸水軟管是可以接受的,但應(yīng)以倒置的“U”形懸掛,以進(jìn)行排水,并且應(yīng)非常靠近其使用的出水口,但不能接觸墻壁或地,并遠(yuǎn)離任何工藝飛濺物。使用后,除非會(huì)在幾分鐘內(nèi)重新使用,否則不應(yīng)將其連接在出水口上。在任何給定的出水口,預(yù)期使用的軟管不得超過一個(gè),以便水取樣員知道要使用哪個(gè)軟管進(jìn)行取樣。

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.

對(duì)于重復(fù)使用的軟管,其管端墊圈的處理是一個(gè)行業(yè)標(biāo)準(zhǔn)實(shí)踐定義較少的領(lǐng)域,但組織的程序需要確保在儲(chǔ)存和放置過程中進(jìn)行衛(wèi)生的處理。例如,將散裝墊圈儲(chǔ)存在以不衛(wèi)生方式取用的容器中,就是一種值得注意的不良做法,可能導(dǎo)致水或產(chǎn)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潔、已消毒或無菌軟管應(yīng)與其端部連接件墊圈一起包裝或分開包裝,并貼有標(biāo)簽注明其狀態(tài)(即:清潔、已消毒、已滅菌)。清潔和消毒過程的文件記錄、相關(guān)SOP以及這些過程的確認(rèn)應(yīng)可供審查。此類“已更新”的軟管和墊圈應(yīng)進(jìn)行包裝或以其他方式保護(hù)以防外部污染,但除非其處理過程使它們保持濕潤(rùn),否則在使用前無需以任何特定方向懸掛。

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.

如果更新軟管的頻率是每天、每班次或每次使用,通常不需要提供理由或驗(yàn)證;但是,如果頻率低于每天一次,則需要提供關(guān)于軟管重復(fù)使用頻率的書面理由和驗(yàn)證?;蛘?,可以提供來自使用點(diǎn)(即軟管末端)的強(qiáng)有力的取樣數(shù)據(jù),證明在整個(gè)使用期間均符合要求。“按需”更換軟管的頻率不是最佳實(shí)踐,并且很難證明采用此方法能保持良好的合規(guī)性。

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