cont'd

¹ The numerator is the number of positive biological indicators that is greater than 97% of the denominator. If the numerator is equal to or greater than the one listed for the corresponding denominator (based on the total number of positive biological indicators on day 7), the length of the incubation time when this occurs is acceptable.

² The denominator is the total number of positive biological indicators on day 7 of incubation.

Example: A manufacturer would like to reduce its biological indicator incubation time to 3 days. The test data show the following:

	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7
Partial cycle #1
Numerator	0	56	57	57	58	59	59
Denominator	59	59	59	59	59	59	59
Percent Growth	-	94.9	96.6	96.6	98.3	100	100

Partial cycle #2	1	34	35	35	35	35	35
Numerator	35	35	35	35	35	35	35
Denominator	2.9	97.1	100	100	100	100	100
Percent Growth

Partial cycle #3
Numerator	0	79	81	Test invalid because percent positive biological indicators is outside the allowable window (30-80%
Denominator
Percent Growth

Partial cycle #4
Numerator	0	47	48	49	49	49	49
Denominator	49	49	49	49	49	49	49
Percent Growth	0	95.9	98.0	100	100	100	100

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