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DRBC Raw

Count

Log

10

Petrifilm

2014-01 KA

Raw Count

Log

10

Petrifilm

2014-01 KB

Raw Count

Log

10

Petrifilm

2014-01 KC

Raw Count

Log

10

18

1.255

17

1.230

18

1.255

21

1.322

17

1.230

9

0.954

21

1.322

20

1.301

22

1.342

20

1.301

16

1.204

19

1.279

21

1.322

15

1.176

13

1.114

24

1.380

12

1.079

21

1.322

17

1.230

14

1.146

1.246

1.197

1.225

1.286

t-test 0.597

0.775

0.200

1

2

Table 7.

Summary of Combined Shelf Life and Lot-to-Lot Consistency for

Candida tropicalis

at the High

3

Inoculation Level.

4

DRBC Raw

Count

Log

10

Petrifilm 2014-

01 KA Raw

Count

Log

10

Petrifilm 2014-

01 KB

Raw Count

Log

10

Petrifilm

2014-01 KC

Raw Count

Log

10

88

1.944

114

2.057

92

1.964

90

1.954

105

2.021

102

2.009

91

1.959

104

2.017

87

1.940

91

1.959

99

1.996

101

2.004

95

1.978

95

1.978

92

1.964

115

2.061

75

1.875

92

1.964

94

1.973

97

1.987

1.952

1.993

1.971

2.005

t-test 0.170

0.520

0.073

5

6

Table 8.

Summary of Combined Shelf Life and Lot-to-Lot Consistency for

E. coli

at the High Inoculation

7

Level.

8

2014-01 KA 2014-01 KB 2014-01 KC

CFU/plate CFU/plate CFU/plate

1

142

0

0

0

0

2

127

0

0

0

0

3

139

0

0

0

0

4

120

0

0

0

0

5

142

0

0

0

0

Organism

Replicate Petrifilm AC

DRBC

Agar

E. coli

25922

High

Inoculation

Level

9

10

Summary of Combined Lot-to-Lot and Shelf Life Stability

11

A paired t-test for equal or unequal variances was conducted to analyze statistical differences between

12

Lot 2014-01 KA (time 0 shelf life), Lot 2014-01 KB (time 0 shelf life), Lot 2014-01 KC (time 0 month shelf

13

life). The p values obtained indicated that there were no significant differences in the results obtained

14

by the Petrifilm RYM Plate method for the detection of yeast or mold at the low or high level at any

15

lot/shelf life combination. The non-target organism,

E. coli

, was not detected one any of the plates at

16

10

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-16D/ PTM Report

ERP Use Only - December 2014