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Recovery Factor Determination in Cleaning Validation

Recovery factor is used in cleaning validation to account for the amount of material not removed from equipment surfaces by swabbing. It is determined by spiking a plate with an API solution, swabbing, and comparing the concentration measured to a standard. The recovery factor formula is used to calculate the percentage of material recovered and the recovery factor, which is the amount results must be multiplied by to adjust for material lost during swabbing. FDA and WHO guidelines state recovery should be determined but do not specify a limit, though WHO considers >80% recovery to be good.

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1K views

Recovery Factor Determination in Cleaning Validation

Recovery factor is used in cleaning validation to account for the amount of material not removed from equipment surfaces by swabbing. It is determined by spiking a plate with an API solution, swabbing, and comparing the concentration measured to a standard. The recovery factor formula is used to calculate the percentage of material recovered and the recovery factor, which is the amount results must be multiplied by to adjust for material lost during swabbing. FDA and WHO guidelines state recovery should be determined but do not specify a limit, though WHO considers >80% recovery to be good.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
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Download as DOCX, PDF, TXT or read online on Scribd
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Recovery Factor Determination in Cleaning Validation

Recovery factor and its determination and calculation in cleaning validation of pharmaceutical manufacturing
equipments.

It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical
manufacturing equipment. Recovery factor is the recovery of swabbed material from the equipment to the
solution.

When we take a sample from the equipment with the cotton swab the entire API associated with the
equipment is not removed by the swab and this error of recovery is managed by the recovery factor
during the calculations in cleaning validation.

A solution of known concentration of API is applied to the stainless steel plate of 10 cm 2 and allow
the plate to air dry. Swab the plate with the cotton swab and dissolve in a suitable diluent.

Diluents should be prepared on the basis of the solubility of the active ingredient. Sonicate the cotton
swab and diluents for 5 minutes to dissolve the content properly. Makeup the solution with the
diluents to get the desired concentration as the standard solution is prepared.

Mix the solution properly and analyze as per the method of analysis using HPLC, Ultra Violet
spectrophotometer or titration. Calculate recovery factor by the following recovery factor formula:

% Recovery = Area of swab sample solution x Standard dilution x 100


Area of the standard solution used x Sample dilution

Recovery Factor = 100/ % Recovery

Suppose % recovery of any swab is 80% then recovery factor of that swab shall be 100/80=1.25.
Results are multiplied by 1.25 to increase the results by 1.25 times that were lost during the
swabbing. Recovery calculation should be done for both chemical and microbiological sampling in
the same manner.

FDA has suggested determining the % recovery of contaminants from the equipment surface
in cleaning validation guidelines but the limit of recovery is not written clearly.
WHO guidelines also say that there should be evidence of the proper recovery of the samples.
According to WHO TRS 937 (page 133) a recovery of >80% is considered good.

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