Maintenance Cycles of pharmaceutical Water Systems
制藥用水系統的維護周期
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?
爲了維護制藥用水系統的确認狀态，需要一(yī)個可靠的維護計劃。這是一(yī)個官方的要求，但是從運行的角度來看它也是有意義的。基于各個部件的關鍵性的維護間隔常常在确認期間進行定義，但是規則是什麽呢？
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(yī)個來源是系統供應商(shāng)給予的推薦，盡管運行經驗也可以被用于制定維護間隔。正如上文所述，維護間隔最初在确認階段進行定義。之後可以通過變更控制對這些間隔進行延長。但是一(yī)開(kāi)始時應該使用什麽規範呢？是否有各個部件使用壽命的經驗值？通常，隔膜閥的膜片應該每年更換。硬水軟化器裏面的樹(shù)脂應該每3-5年變換一(yī)次；這可以作爲一(yī)個防止生(shēng)物(wù)膜形成的預防措施看待。對于反滲透、超濾和EDI模塊，應該預定3-5年進行一(yī)次預防性更換，這取決于熱消毒的頻(pín)度。臭氧系統的臭氧監測點應該每1-2年更換一(yī)次。用于消除臭氧的紫外(wài)燈應該最遲在使用8000小(xiǎo)時後或者12個月後更換。
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.
這些值僅作爲一(yī)般參考。個别情況可能需要更短或可以更長的間隔。最開(kāi)始的維護計劃應該在PQ開(kāi)始階段制定完成。
