Maintenance Cycles of pharmaceutical Water Systems
制藥用水系統(tǒng)的維護(hù)周期
To maintain the qualified condition of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?
為了維護(hù)制藥用水系統(tǒng)的確認(rèn)狀態(tài)，需要一個可靠的維護(hù)計(jì)劃。這是一個官方的要求，但是從運(yùn)行的角度來看它也是有意義的。基于各個部件的關(guān)鍵性的維護(hù)間隔常常在確認(rèn)期間進(jìn)行定義，但是規(guī)則是什么呢？
One source are the recommendations given by the system suppliers; although operational experiences can also be used for specifying the maintenance intervals. As mentioned before, maintenance intervals are initially determined during the qualification phase. A later extension of these intervals is possible via change control. But what specifications should be used to start with? Are there empirical values for the lifetime of individual components? It can generally be said that membranes in diaphragm valves should be replaced annually. The resin inside the softener should be changed every 3-5 years; this can be seen as a preventive measure against biofilm formation. For reverse osmosis modules as well as ultrafiltration and EDI modules, a preventive replacing every 3-5 years should be scheduled, depending on the frequency of thermal sanitisation. The ozone measuring point of ozonized systems should be replaced every 1-2 years. The UV lamps used for ozone elimination should be changed after 8000 hours of use or after 12 months, at the latest.
一個來源是系統(tǒng)供應(yīng)商給予的推薦，盡管運(yùn)行經(jīng)驗(yàn)也可以被用于制定維護(hù)間隔。正如上文所述，維護(hù)間隔最初在確認(rèn)階段進(jìn)行定義。之后可以通過變更控制對這些間隔進(jìn)行延長。但是一開始時應(yīng)該使用什么規(guī)范呢？是否有各個部件使用壽命的經(jīng)驗(yàn)值？通常，隔膜閥的膜片應(yīng)該每年更換。硬水軟化器里面的樹脂應(yīng)該每3-5年變換一次；這可以作為一個防止生物膜形成的預(yù)防措施看待。對于反滲透、超濾和EDI模塊，應(yīng)該預(yù)定3-5年進(jìn)行一次預(yù)防性更換，這取決于熱消毒的頻度。臭氧系統(tǒng)的臭氧監(jiān)測點(diǎn)應(yīng)該每1-2年更換一次。用于消除臭氧的紫外燈應(yīng)該最遲在使用8000小時后或者12個月后更換。
These values are merely general reference values; individual cases might call for shorter or longer intervals. A first maintenance plan should be finished by the beginning of the PQ phase.
這些值僅作為一般參考。個別情況可能需要更短或可以更長的間隔。最開始的維護(hù)計(jì)劃應(yīng)該在PQ開始階段制定完成。
