what is the best detergent to be used for cleaning validation study?
I also want to know the best type of sawb to use concerning the Quality and price.
thanks alot
There is nothing like a best detergent. You must look factors like
-How costly in that detergent?
-How effectively the detergent cleans?
-Does it react with the surfaces when used?
-How minimum (Concentration)can be effectively used for cleaning?
-Can it be easily washed with hot water rinsing cycles?
-Does is poses an health hazard or any Skin reactions to users?
-Is it approved by FDA?
-Does this has a cross reactivity with the product to be cleaned?
Nothing is absolute in Pharma/Biopharma industry when it comes to cleaning.
you should have several cleaners on hand - neutral, alkaline(base), and acidic. try to find the pH of the compound you are cleaning and clean it with the cleaner that has the pH opposite of the compound - or the neutral cleaner if the pH is neutral. most drugs are somewhat acidic and an alkaline cleaner works best. contact the STERIS corporation- they are a major supplier of pharma process cleaners for equipment and rooms. as a free service to customers they can do testing to help determine the best cleaners for some compounds. there are many different swab media available - they must be shown to be able to recover the greater part of the drug with the proper solvent before the testing method is valid. you may have to keep more than one swab type in stock. TEXWIPE makes several kinds. you also need to develop a method- either by surface swabbing or rinse water testing- to assure that cleaning agent (detergent) residue has been removed.
Thanks alot for your great help
Hi Durga, you mentioned the need to check if the detergent is FDA approved. Is there a list of FDA approved detergents?
Regards
Neena
Teepol is the FDA approved cleaning agent and it complies all the DURGA SIR requirements.
With Regards,
Sitarama Raju
SMS Pharma
Hi,
Might be this will of a littile bit help…
Just refer the FDA Code of Federal Regulations (21 CFR 178.1010).
Approved no-rinse food contact sanitizes and nonproduct contact sanitzers, their formulations and usage levels are listed in this.
Happy Reading !
Fair chemistry of detergent, have a look on this.
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Happy Reading !
Detegent in cleaning.pdf (105.0 KB)
unable to open the attachment
This link is good, I just checked it.