Dear all,
Can any one through light on the percentage of Isopropyl alcohol to be used at various areas like disinfecting items before placing them in pass through box, aseptic and non aseptic areas in a sterile dry powder section.Are there any guidelines on this in USFDA,EUGMP, etc.
With regards,
Sreekanth Kosaraju
merci thgaks you choukran
70% of ipa concentration is used in sterile area
Yes 70% is quite standard.
Why 70 % ?
Can it is use lower than or higher this concentration.
[quote=rudra]why 70 % ?
Can it is use lower than or higher this concentration.[/quote]
go ahead, to the higher level, but do not decrease
Using 70% is optimum…less than that you won’t get the same amount of kill…higher than that evaporates too quickly and you won’t get the dwell time.
validate the different concentrations and find the optimum concentration where microbial growth is inhibited
I heard that the cell membrane solifies in the high concetration. so cannot penetrate into the inside of cell
It has been shown (various white papers, unfortunately, I do not have a reference). That higher concentrations of IPA, does not increase kill or efficacy of the IPA at all, and actually decreases efficacy (maybe due to JH-RYU’s comment). 70% is pretty standard and is super inexpensive and avialable from all sorts of suppliers. Agencies pretty much just accept it.
I wouldn’t spend the time or money to validate difference. Sometimes its not better to challenge assumptions, I think in this case just go with industry standards.