制药用水系统的维护周期

 作者:网站管理员
 日期:2019-08-15
 浏览次数:26
Maintenance Cycles of pharmaceutical Water Systems
制药用水系统的维护周期

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?
为了维护制药用水系统的确认状态,需要一个可靠的维护计划。这是一个官方的要求,但是从运行的角度来看它也是有意义的。基于各个部件的关键性的维护间隔常常在确认期间进行定义,但是规则是什么呢?

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.
一个来源是系统供应商给予的推荐,尽管运行经验也可以被用于制定维护间隔。正如上文所述,维护间隔最初在确认阶段进行定义。之后可以通过变更控制对这些间隔进行延长。但是一开始时应该使用什么规范呢?是否有各个部件使用寿命的经验值?通常,隔膜阀的膜片应该每年更换。硬水软化器里面的树脂应该每3-5年变换一次;这可以作为一个防止生物膜形成的预防措施看待。对于反渗透、超滤和EDI模块,应该预定3-5年进行一次预防性更换,这取决于热消毒的频度。臭氧系统的臭氧监测点应该每1-2年更换一次。用于消除臭氧的紫外灯应该最迟在使用8000小时后或者12个月后更换。

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.
这些值仅作为一般参考。个别情况可能需要更短或可以更长的间隔。最开始的维护计划应该在PQ开始阶段制定完成。