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 18months 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 Dvalue,the method used to determine such Dvalue,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 ATCCnumber 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 Dvalueis 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 0.7to 0.8µm,and length 2to 3µm;the endospores are oval and central and the cells are not swollen;when incubated aerobically in appropriate media at 30to 35,growth occurs within 24hours,and similar inoculated media incubated concomitantly at 55to 60show no evidence of growth in the same period;agar colonies have a dull appearance and may be cream or brown-colored;when incubated in nutrient broth it develops a pellicle,and shows little or no turbidity;when examined under conventional biochemical tests for microbial characterization,it develops a black pigment with tyrosine,it liquefies gelatin,utilizes citrate but not propionate or hippurate,reduces nitrate,and hydrolyzes both starch and glucose with no gas production;it shows a positive catalase reaction and gives a positive result with the Voges-Proskauer test.

Resistance performance tests—

Purity—

Disposal— Prior to destruction or discard,sterilize it by steam at 121for not less than 30minutes,or by not less than an equivalent method recommended by the manufacturer.This includes a strip used in test procedures for strips themselves.

Expert Committee:(AMB)Analytical Microbiology

USP28–NF23Page 258

Phone Number:1-301-816-8225