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What is a biological indicator

what is a biological indicator

Biological indicators are a device to monitor the sterilization process that consists of a standardized population of bacterial spores known to be resistant to the mode of sterilization being monitored. Biological indicators indicate that all the parameters necessary for sterilization were present.

As per the FDA, “a biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.” [21 CFR 880.2800(a)(1)]

Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant microorganisms (i.e. Bacillus spores), and not by merely testing the physical and chemical conditions necessary for sterilization. Since the Bacillus spores used in biological indicators are more resistant and present in greater numbers than are the common

microbial contaminants found on patient-care equipment, the demonstration that the biological indicator has been inactivated strongly implies that other potential pathogens in the load have been killed.

ATS, Inc. provides high quality, FDA approved, biological indicators for sterilizer monitoring using either a Mail-In or In-Office testing system.


§ Autoclave Testing Service, Inc. is one of the first companies nationwide to offer a Mail-In sterilizer monitoring service using biological indicators. Serving the healthcare industry throughout the United States and Canada since 1986, we have thousands of satisfied customers.

§ We have on-line test results allowing you to access your results at your convenience! Your Sterilizer Test Report (STR) is posted on-line upon completion of culturing, offering minimum turn-around time.

§ We have 24-hour test results for Steam sterilizers!

§ We have a comprehensive Glossary of Terms related to the sterile processing area (scroll below to view the Glossary). This is invaluable information, assisting you with this important area of your facility.

ATS, Inc. now stocks sterilization pouches, sterilizer cleaners, chemical indicator products, sterilizers (new and used), ultrasonic cleaners, water distillers, and more! (see Supplies ).

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