[quote=kandasani]Dear Ruth Cunniffe,
thanks for the promt reply.
[COLOR=“Blue”]1.i need information what is the correlation b/w Recovery factor study and it’s application while calculation of MACO
2.is different sizes of swabing area will influence the MACO or not?
3.basics of 0.1% concept in cleaning validation[/color]
if u know pl share the information
have a nice day
Dear Ruth Cunniffe,
Your first query,
correlation b/w Recovery factor study and it’s application while calculation of MACO
The requirement of determining recovery is to determine the accuracy and precission of your analytical method which is challenged with sampling procedure. Recovery determines to waht extent (expressed in percent) your sampling and analytical methods are able to determine the residue. It is generally determined by coupon sampling. Suppose you got the recovery of 80%, then the recovery factor will be 80% i.e. 0.8. And now, what you have to do is to multiply the MACO calculated with respect to 0.1% dose or 10 ppm criteria by the recovery factor. And this will be your new MACO against which you should tested the residue left after your cleaning procedure. i.e. New MACO = MACO (0.1% and 10 ppm) X Recovery factor.
Or you could also keep the MACO unchanged and consider the Recovery factor during analysis. In this case you should analyse the sample and quantify the residue. Then divide the quantity of the residue by the recovery factor and you will get the actual quantity of the residue. Then make comparison between obtained quantity of the residue and your acceptance criteria.
is different sizes of swabing area will influence the MACO or not?
Regarding this I would like to say that the MACO are generally determined in unit of weight per surface area (e.g. mcg/sq.cm). So, what the swabing area you may have it will not affect your MACO as it is in terms of the mcg/sq. cm. Increasing swabing area is helpful when your analytical method do have LOQ higher than your residue. Suppose your analytical method have LOQ of 10 mcg and you do have residue of 5 mcg per 25 sq. cm, then in this case you could increase swab area to 100 sq.cm and can increase the residue to 20 mcg which is higher than your LOQ and your analytical method will certainly detect it.
basics of 0.1% concept in cleaning validation
While using 10 ppm criteria it was considered that the residues are equally toxic to heavy materials. According to 10 ppm criteria all the residues have same acceptance criteria despite of their toxicity. But there are many pharmaceutical products which are more toxic than heacy materials. So, taking this into consideration 0.1% concept was developed which somehow relate the toxicity of the materials in term of the dose. According to this if the dose is high (drugs are less toxic), then the acceptance criteria is high and if the dose is very low (more toxic) then the acceptance criteria is very small.
Many pharmaceutical companies have acceptance criteria directly in term of toxicity which is determined from Acceptable Daily Intake (calculated by taking reference of LD 50) of the drug. But I would like to prefer 0.1% dose criteria and believe that this should be used only when you do not have dose of the residue. e.g. in case of detergents.
Hope you got your answer,