Page 191 - Assurance of Sterility for Sensitive Combination Products and Materials

172 Assurance of sterility for sensitive combination products and materials

Proportion of the

table 0.11 0.076 0.148

10 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0.10 0.042 0.283

0.00 0.000 0.139
9 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0.15 0.071 0.344
8 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 1

0.05 0.018 0.216
7 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Tables of Random values where the probability of the value 1 is 10%.
0.15 0.071 0.344
6 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 1 0
Group

5 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 1 0 1 0 0 0.20 0.104 0.401

0.10 0.042 0.283
4 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0

0.15 0.071 0.344
3 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0

0.05 0.018 0.216
2 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0.10 0.042 0.283
1 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0

Table 7.2 Sample 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Proportion 90% Lower CI 90% Upper CI