淋洗水回收率验证如何做？
清洁验证
对于有多种材质组成的生产设备，淋洗水的回收率如何做？
2017-09-13 21:14 Chjun     
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以下是PDA TR 29对于淋洗取样回收率的描述：

6.5.3 Rinse Recovery
冲淋法回收率
Rinse recovery studies address the validity of rinse sampling for that residue. They demonstrate that ifthe
residue were on a surface, that residue would be effectively removed and could be analyzed in therinse
solution. Rinse recovery studies address the U.S. FDA’s “dirty pot” and “baby/bath water” analogies(20).
Rinse recovery studies, like swab recovery studies, can be performed on coupons that havebeen spiked
with solutions of the target residue and then allowed to dry. For swab recoveries, it is necessaryto perform
the exact swabbing procedure to be used in the cleaning validation protocol. For rinsesampling, in contrast,
the exact rinsing procedure (except for the special case of extraction sampling)cannot be duplicated in the
laboratory. However, it is possible to simulate the rinsing procedure in thelaboratory. Where possible, the
conditions of the simulated rinse should be the same as the equipmentrinsing situation. This includes
selection of rinsing solvent as well as the temperature of the rinsing solvent.In other cases, the rinsing
conditions should be selected as the same or a worst case as comparedto the equipment rinsing situation.
For example, the ratio of solvent to sampled surface area should bethe same or lower in the recovery study
as compared to the equipment rinsing situation.
 
One method of simulating the rinse process is to suspend a spiked coupon above a clean collectionvessel,
and cascade rinse solution across the surface into the collection vessel. Another method is tospike the
bottom of a beaker of the appropriate material of construction, allow the residue to dry,add rinse solution to
the beaker and apply gentle agitation for a time which approximates the time ofthe final rinse. The rinse
solution is either pipetted or decanted from the beaker and analyzed. A thirdoption, used in cases where a
beaker of suitable material of construction is not available, is to placea spiked coupon in the bottom of a
beaker and perform a simulated rinse as in the second method.

 

2017-10-08 16:35 恒野     
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Chjun 2017-10-09 09:45

对于多种材质组成的设备，淋洗水的回收率如何做？

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