This document discusses sterility indicators, which are used to check whether sterilization processes have eliminated microorganisms. It describes three main types of sterility indicators: physical indicators monitor sterilization parameters like time and temperature; chemical indicators undergo color changes to indicate sterilization; and biological indicators use bacterial spores to confirm sterilization through lack of growth. The document provides examples of specific indicators used for different sterilization methods and concludes that sterility indicators visually confirm cleaning and sterilization procedures were properly conducted.

1. HYGIA INSTITUTE OF PHARMACY
Under the supervision of-
Miss. Pragya Shukla
(Assistant professor)
TOPIC- STERILITY INDICATORS
Subject-Pharmaceutical microbiology
(BP303T)
Presented by-
Md. Arman
B.Pharm 2nd year
Roll no.-2108950500049
Faizullahganj,Prabandh Nagar,Ghaila road, Lucknow-226020
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2. CONTENTS
o Introduction
o Sterility indicators
o Types of sterility indicators
1) Physical indicator
2) Chemical indicator
3) Biological indicator
o Conclusion
o References
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3. INTRODUCTION
o Sterilization:- Sterilization is process that
eliminates,remove or kill all form of life,
microorganism,spores by physical and chemical method.[1]
o Sterility testing:- It is defined as the test that confirms that
the products are free from the presence of the
microorganisms.[1]
o Sterility testing done by two methods:-
I. Direct inoculation method
II. Membrane filtration method
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4. STERILITY INDICATORS
o Sterility indicators needed to check the whether microbial
contamination occurs or not.[2]
o It is defined as,the indicator that are used for check the
quality of sterilization and monitoring the sterilization
process.[2]
o These are basically two types of controls,
• Control on the process of sterilization i.e. sterility
indicator or sterility monitor.
• Sterility testing of product.
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Figure:1

5. TYPES OF STERILITY INDICATORS
1. Physical indicator
2. Chemical indicator
3. Biological indicator
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6. 1. PHYSICAL INDICATOR
o The display on the sterilize or a recording device that
print the parameters like time,temperature,pressure
associated with each sterilization cycle for each
load,such indicator are consider as physical indicator.[3]
o Thermocouple is use for the heat distribution and
penetration within sterilizer.[3]
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Figure:2 Figure:3

7. Dry heat
sterilization
Moist heat
sterilization
Filteration
sterilization
Gaseous
sterilization
Temperature recording
chart
Temperature recording
chart
Bubble point chart
Temperature recording
chart
1. PHYSICAL INDICATOR[3]
METHOD DEVICE
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8. 2. CHEMICAL INDICATOR
o Chemical indicator based on the ability of sterilization
process to produce changes in the physical and chemical
characteristics of chemical substance.
o Chemical indicator,these are the substance that are used
in the process of sterilization in order to indicate the
process of sterilization is going as per requirements or it
may indicate that the product are sterilize.
o Generally chemical indicator undergoes melting or color
change.
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Figure:4

9. 3. BIOLOGICAL INDICATOR
 The biological indicators are the preparation of bacterial
spores which are usually in the form of suspension in
water or culture medium or of spores dried or that is
carried either directly by some of the items to be
sterilize.[3]
 According to the sterilization process we used that kind
of bacterial sporse like sporse of bacillus subtilis is
used as biological indicator in dry heat sterilization
process to determine D-value, while bacillus stereo-
thermophilus spores are used in case of moist heat
sterilization.[3]
 Most commom biological indicator and sterilization
processes are as follow,
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10. BIOLOGICAL INDICATOR
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Figure:5

11. CONCLUSION
Changing appearance in colour or pattern ,the sterilization
indicators visually show if cleaning condition are passing
or procedures have been completed.
With the temperature resistance required to endure the
purification, the sterilization indicator are available in the
different form such as tapes, ampoules and sticks.
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12. REFERENCES
1. Das Kuntal, “Pharmaceutical Microbiology” First
Edition Published by Nirali Prakashan, page no.2.34-
2.37.
2. https://www.youtube.com/playlist?list...
3. http://www.pharmalecture.com
4.
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https://sebiomedical.com/product/tutt
nauer-wtl198-0056

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