Low Temperature Sterilization Process (115C) and Its Validation : Pharmaceutical Guidelines

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Low Temperature Sterilization Process (115C) and Its Validation

Learn how sterilization is done for heat sensitive material at lower temperature below 121 C and its validation using Bacillus subtilis (Bacillus atrophaeus) ) ATCC 5230 as biological indicator.

CATEGORIES: MICROBIOLOGY , STERILIZATION , VALIDATION NOV 13, 2013

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Sterilization of the media and material is generally done at 121 C

but sometimes it is required to do at low temperature (115 C)
because of heat sensitivity of the material. This sterilization below 121 C
is called Low Temperature Sterilization. Reinforced Medium, Rappaport Vassiliadis Medium, Wilson and Blair's BBS
Agar, GN Broth, Triple Sugar Iron Agar, Bismuth Sulphite Agar Medium etc. are
sterilized at 115C and 10 psi pressure. These media are sterilized separately
at this temperature. These culture media contains some heat sensitive ingredients that can degrade
at 121C
losing their nutritive quality. This media shall not support the growth of specified
microorganisms. When these media are sterilized at high temperature, the
microorganism can grow but shall not develop the characteristic colonies due to
the degradation of the heat sensitive ingredients.
Related: Terminal Sterilization of Sterile Pharmaceutical Preparations 121 C
sterilization cycle is run for 15 minutes but when temperature is decreased to
115 C,
time of sterilization is increased for effective killing of the microorganisms.
It is recommended to run the 115 C sterilization cycle for 30 minutes
or it can be calculated by the D value. Suppose D value at 115 C
is 3.75 and we want 8 log reduction then we have to run the sterilization cycle 3.75x8=30
minutes. All sterilization processes must be validated. Low temperature sterilization
validation is done by using Bacillus
subtilis (Bacillus atrophaeus) ATCC 5230. Strips and ampoules containing
the spores of B. subtilis are sterilized with the media load similarly as the
normal autoclave validation. Every strip contains 1x106 spores. Related:SOP for Qualification of Biological Indicator Spore strips are incubated in soybean casein digest medium at 35C
for seven days. Growth should not be observed for a valid sterilization

http://www.pharmaguideline.com/2013/11/low-temperature-sterilization-process-validation.html[08-Apr-14 9:45:17 AM]

Low Temperature Sterilization Process (115C) and Its Validation : Pharmaceutical Guidelines

process. Growth of the biological indicator is indicated by the turbidity. Turbidity Improper sterilization No turbidity Proper sterilization If ampoules of Bacillus subtilis are used as biological indicator then media
should released from the bulb for the growth of the spores. Ampoules are also
incubated at 35C for seven days and observed for the change of color of
the ampoule. Also see:Performance Evaluation of Biological Indicators

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Further Reading:,
,
1. Analytical Method Development Process for New Products 2. Tips to Develop Equipment Cleaning Procedure 3. Is Fungal Count Acceptable in Pharmaceutical Classified Area? 4. Microbial Analysis of Purified Water and Water of Injection 5. Importance and Determination of F0 Value in Sterilization 6. Determination of Z-Value for Biological Indicators 7. Log Reduction (D Value) and Sterility Assurance Level (SAL) in Sterilization 8. Validation of Pure Steam 9. Low Temperature Sterilization Process (115C) and Its Validation 10. Temperature and Humidity Validation/Mapping in Storage Area

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ABOUT THE AUTHOR

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Email: info@pharmaguideline.com

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