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Sunday, June 5, 2011

Placebo batch for evaluation and validating efficacy of cleaning process:

Validating efficacy of cleaning process with placebo batch :

Some pharmaceutical manufacturers use placebo product to evaluate and validate efficacy of cleaning procedures, process so as to simulate the exact process a actual product may face by using similar parameters for operation, so that the placebo product get contaminated with the residue of unwanted material from previous batch or cleaning if at all is present after cleaning.
And then a sample of placebo product batch thus produced is tested for the residue after cleaning. Since there are lot other factors which affect the reliability of this methods which must be considered before using placebo batch method for cleaning validation.
1. The uniform distribution of the residue of previous product after cleaning equipments or cleaning agent after cleaning process in equipment system is not always sure. Example when the discharge port or the delivery shut is contaminated the residue from that point may not be distributed to placebo batch it will mostly contaminate initial part of the batch while discharging or removing from the blender.
2. The large particle size residue may not distribute evenly in the batch
3. There may be a instance that the residue may be remaining after cleaning the equipment to the unacceptable level but in the placebo batch it is distributed and diluted to the level of so that the analytical power of the method used is not able to find the residue.


Therefore regulatory agencies advise the use of rinse water /rinse solution and swab test analysis in addition to the placebo batch method for cleaning validation of cleaning process.
Good manufacturing practices
Also see
Use of  Placebo in Clinical Trials

Pharmaceutical Validation

Clean Room Classification

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