Sterilization of pharmaceutical articles is affected by a lot of
factors as temperature, population of microbes, quantity of material, sterilization
exposure time etc.
Log reduction plays important role in the sterilization process. It shows
the potential of the sterilization process. One log reduction shows the
decrease in microbial population by 10 times. It means if a solution has 100
cfu, after 1 log reduction it will have 10 cfu and 1 cfu after 2 log reduction.
It is 90% reduction in a specified microbial population. The time (in minutes)
required to achieve 1 log reduction (at specified temperature) is called
Dvalue.
Generally in sterilization it is required to achieve a SAL (sterility
assurance level) of 10^{6} and an additional 6 log reduction. It means
all 10^{6} (one million) organisms present in the material are killed
effectively and assured by extra 6 log reduction. Hence total 12 log reduction
is required. In 6 log reduction the microbial population shall be reduced from 10^{6}
to 1 and in other 6 log reduction population shall be reduced to 0.000001 that
assures the sterility of the sterilized material.
For example, if a material has a bioburden of 540 cfu then to reduce
the microbial population from 540 to 1 = log (540) = 2.73. It shows that only
2.73 log reduction is required to decrease the microbial population from 540 to
1. Total log reduction required for sterilization of the material with SAL
value of 10^{6 }= 2.73+6 = 8.73. Total sterilization time at 121°C
with D value of 2.5 min/log shall be 2.5x8.73 = 21.82 minutes.
In a pharmaceutical sterilization with 6 log SAL where 12 log reduction
is required, sterilization time should be 2.5x12 = 30 minutes. Most of the
biological indicators have a population of 10^{6} spores and 6 log
reduction is required to reduce the population to 1. Another 6 log reduction is
required for SAL value of 10^{6}.
Also see: Procedure for Autoclave Validation
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
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great work
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