Biological Indicator for Steam Sterilization, Self-Contained
» Biological Indicator for Steam Sterilization, Self-Contained, is a Biological Indicator for Steam Sterilization, Paper Carrier individually packaged in a suitable container readily penetrable by steam and designed to hold an appropriate bacteriological culture medium, so as to enable the packaged carrier, after subjection to saturated steam sterilization conditions, to be incubated in the supplied medium in a self-contained system. The supplied medium may contain a suitable indicator as a convenience for determining by a color change whether or not spores have survived. The design of the self-contained system is such that, after exposure to the specified sterilization conditions and inoculation of the medium under closed conditions as stated in the labeling, there is no loss of medium and inoculum during subsequent transport and handling, if done according to the provided instructions. The materials of which the self-contained system are made are such that there is no retention or release of any substance that may cause inhibition of growth of surviving spores under the incubation conditions stated in the labeling.
Packaging and storage
Preserve in the original package under the conditions recommended on the label, and protect from light, from substances that may adversely affect the contained microorganisms, from excessive heat, and from moisture.
Expiration date
The expiration date is determined on the basis of stability studies and is not less than 18 months from the date of manufacture, the date of manufacture being the date on which the first determination of the total viable spore count was made.
Labeling
Label it to state that it is a Biological Indicator for Steam Sterilization, Self-Contained; to indicate the D value of the self-contained system, the method used to determine such D value (i.e., by spore count or fraction negative procedure after graded exposures to the sterilization conditions); the survival time and kill time under the specified conditions stated on the label; its particular total viable spore count, with a statement that such count has been determined after preliminary heat treatment; and its recommended storage conditions. State on the labeling that the supplied bacteriological medium will meet requirements for growth-promoting ability, the strain and ATCC number from which the spores were derived, and the instructions for spore recovery and for safe disposal of the indicator unit. Also indicate in the labeling that the stated resistance characteristics are reproducible only under steam sterilization conditions at the stated temperature and only under the exact conditions under which it was determined, that the user would not necessarily obtain the same result, and that the user should determine the suitability of the biological indicator for the particular use.
Identification
It meets the requirements of the Identification test under Biological Indicator for Steam Sterilization, Paper Carrier.
Resistance performance tests
D value
Proceed as directed for the relevant procedure for D Value under Biological IndicatorsResistance Performance Tests
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Survival time and kill time
Follow the procedure for Survival Time and Kill Time in the section Steam Sterilization, Self-Contained, under Biological IndicatorsResistance Performance Tests
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Total viable spore count
Proceed as directed for Total Viable Spore Count under Biological IndicatorsResistance Performance Tests
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Medium suitability
Sterility
Incubate 10 self-contained biological indicator systems at 55
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Growth promotion of medium prior to sterilization treatment
Submerge 10 self-contained units in a water bath maintained at 95
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Growth promotion of medium after exposure to sterilization conditions
Expose the specified number of units for both the Survival Time and Kill time stated in the labeling, as described in the section Biological Indicator for Steam Sterilization, Self-Contained under Biological IndicatorsResistance Performance Tests
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Ability of medium to support growth after exposure to the sterilization conditions
Take a stated number of units (e.g., 10) after they have been exposed for each Kill time stated in the labeling as directed in the preceding section. Aseptically remove and pool the medium from each unit. Prepare a suspension of the indicator microorganism as directed for Total Viable Spore Counts under Biological Indicator for Steam Sterilization, Paper Carrier. Prepare a dilution of that suspension so as to contain 100 to 1000 viable microorganisms in one mL. Inoculate the pooled medium with enough suspension to contain a total of 100 to 1000 microorganisms in a 10 mL aliquot of not more than the volume from 10 units of the pooled medium. Incubate the inoculated pooled medium as directed for Total Viable Spore Count. Clear evidence of growth is obtained within 7 days.
Disposal
Prior to destruction or discard, sterilize it by steam at 121
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Auxiliary Information
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USP38NF33 Page 2439
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