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什么是placebo cleaning???PDA TR29中提到这个概念,仅供参考!
3.3.1.1.3 Placebo Batches as a Cleaning Method
Placebo cleaning is another type of in-place cleaning. For certain highly viscous ointments or products,
it may be feasible to use a placebo run as a method of cleaning equipment. This approach requires
the use of a placebo that has no detrimental quality impact on the next product manufactured in the
equipment. The principle of using a placebo batch for cleaning is that the action of the placebo run-
ning through the equipment would clean the equipment of drug residues or process residuals from
the previous batch. The advantage for this type of cleaning is that the placebo is processed through
the equipment in the same fashion as the manufactured product. Therefore, the material would touch
the same surfaces and in the same manner as the next product batch. Disadvantages of this method
include the cost of cleaning and the difficulty of demonstration of the effectiveness of the process.
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