ive completed cleaning validation report and ive used solubility parameter to choose the worst case active/product. our main solvent for cleaning is purified water-even though the few worst case products are practically insoluble.ive successfully completed the cleaning validation which has shown that the residual carry-over are at acceptable level of cleanliness.my worry is can this bring problems during audits since we dont use solvents that can dissolve the materials practically insoluble in water?
no u r right,water is universal solvent.doing worst case by taking water as solvent is the most common practice.
no regulatory body can take objection on it…
Regards
Prasad Aparajit
Aventis Pharma
Ankleshwar
can you give in detail what approach you given as acceptance ,
so that i can send in detail for you
[quote=pvalidation]no u r right,water is universal solvent.doing worst case by taking water as solvent is the most common practice.
no regulatory body can take objection on it…
Regards
Prasad Aparajit
Aventis Pharma
Ankleshwar[/quote]
Yes, regulatory bodies can be objected if the selected product is practically insoluble in water, and how any one can perform validation of CLV method in it, in my opinion, select solvent which easily dissolved the targeted API but it is better to pick water as an extracting solvent but it is not mandatory where it can’t.
Thanks
U Will Be In Problem If U Does Not Justify The Use Of Water And Avoiding Solvents If Ur Justification Is Clear No One Can Take Objection On It.
Here i see this case differently, the problem is the selection of worse case. You have selected the worse case only on the basis of water solubility, U should make a High toxic-Low soluble criteria for the Worse case selection. I think this can be objectionable, Although your results are satisfactory for a non soluble drug.
Thank you for great information
when intended API is insoluble in water, suitable solvent can be taken for sampling ,provided after swabbing need to be washed thoroughly with water sampled area on the equipment.
Dear All,
Have you considered that the analytical method validation for your product swabbing technique should have included lab-based coupon tests for your chosen worst case product. These would most likely have produced a recovery factor based on your swabbing solvent (water). The factor is most likely to be in the range of 75 to 85% recovery or greater. This correction factor can then be applied to your actual swab results and mitigates any lack of recovery due to insolubility. Happy days 
Regards,
David
Pure Water is the common solvent used for cleaning, but it depends on whether you use COP or CIP cleaning , cause for COP, the common solvent is water with detergent ,and for the CIP it can be diferent solvents like acid or base solutions .The high temperature can be of a great help when APIs are not soluble in ambient temperature.
[quote=Shahnawaz]Yes, regulatory bodies can be objected if the selected product is practically insoluble in water, and how any one can perform validation of CLV method in it, in my opinion, select solvent which easily dissolved the targeted API but it is better to pick water as an extracting solvent but it is not mandatory where it can’t.
Thanks[/quote]
Dear Shahnawaz,
I do not think there are no points for objection by the regulatory bodies for selecting the solvent as water for insoluble drug molecules. Cleaning validation means the documented evidence which shows that your cleaning procedure is effective to minimise the contaminant or residue to predetermined acceptance level. And Acceptance criteria are independent to selection of solvent.
If you have data that water can be effectively used to minimize the residue to predetermined acceptance criteria then there will be no objection. What will happen by taking water is that your cleaning process may become some lengthy or you should consider other factors as time, temperature and mechanics during your cleaning processes.
So, I donot think there will be any objections and what I believe is that use of purified water should be always promoted for selecting as cleansing agent as it is cheap, easily available and do not have issue of its own residue.
Dear all
Thank you for most valuable responses and timely advice. I have learnt a great deal. Thank you Professor.