Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
» Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, is a defined preparation of viable spores made from a culture derived from a specified strain of Bacillus subtilis subspecies niger on a suitable grade of paper carrier, individually packaged in a suitable container readily penetrable by ethylene oxide sterilizing gas mixture, and characterized for predictable resistance to sterilization with such gas mixture. The packaged Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, has a particular labeled spore count per carrier of not less than 104 and not more than 109 spores. Where labeled for and subjected to particular ethylene oxide sterilization conditions of a stated gaseous mixture, temperature, and relative humidity, it has a survival time and kill time appropriate to the labeled spore count and to the decimal reduction value (D value, in minutes) of the preparation, specified by:
Survival time (in minutes) = not less than (labeled D value) × (log labeled spore count per carrier 2), and
Kill time (in minutes) = not more than (labeled D value) × (log labeled spore count per carrier + 4).
Packaging and storage
Preserve in the original package under the conditions recommended on the label, and protect it from light, toxic substances, excessive heat, and moisture. The packaging and container material shall be such that it does not adversely affect the performance of the article used as directed in the labeling.
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 Ethylene Oxide Sterilization, Paper Carrier; to indicate its D value, 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 specified sterilization 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 in the labeling the size of the paper carrier, the strain and ATCC number from which the spores were derived, and instructions for spore recovery and for safe disposal of the indicator. Indicate in the labeling that the stated D value is reproducible 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
The biological indicator organism complies substantially with the morphological, cultural, and biochemical characteristics of the strain of Bacillus subtilis, ATCC No. 9372, designated subspecies niger: under microscopic examination it consists of Gram-positive rods of width 0.7 to 0.8 µm, and length 2 to 3 µm; the endospores are oval and central and the cells are not swollen; when incubated aerobically in appropriate media at 30
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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
Proceed as directed for Survival Time and Kill Time in the section Ethylene Oxide Sterilization, Paper Carrier, under Biological IndicatorsResistance Performance Tests
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Total viable spore count
Follow the procedure for Total Viable Spore Count in the section Ethylene Oxide Sterilization, Paper Carrier, under Biological IndicatorsResistance Performance Tests
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Purity
Presence of contamination by other microorganisms
By examination of the spores on a suitable plate culture medium, there is no evidence of contamination with other microorganisms.
Disposal
Prior to destruction or discard, sterilize it by steam at 121
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Auxiliary Information
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USP35NF30 Page 2357
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