Dear team,
May i know the reason for the considering 6 log reduction for autoclave validation as per which guidelines we are following that phenomenon.
Please give me your valuable suggestions and answers.
Thanks,
Ratna raju
Dear team,
May i know the reason for the considering 6 log reduction for autoclave validation as per which guidelines we are following that phenomenon.
Please give me your valuable suggestions and answers.
Thanks,
Ratna raju
in the pharmaceutical industry, in order to define a unit as sterile one
must be able to certify, on a statistical basis related to the conditions of preparation and
sterilization of that specific product and of that specific batch, that less than one unit in
a million is exposed to the risk of not being sterile. The probability of finding a nonsterile
unit (PNSU = Probability of Non Sterile Unit, or SAL) must therefore be smaller (as
mathematical value) than 10−6.
*This means that at the end of each minute at 121°C in moist-heat conditions the
number of microorganisms reduces to one tenth of the number at the beginning
of that minute.
*Therefore, if a unit is kept at 121°C in moist-heat conditions for 3 minutes, the
number of microorganisms contained therein is reduced to one thousandth (1/10
x 1/10 x 1/10 = 1/1000) of the initial number.
F0 - A technical note – Doc. 352178v2 - Copyright © 2014 Fedegari Group 28