Biomedical Engineering Reference
In-Depth Information
Validated hold time
10
8
6
Run #1
Run #2
Run #3
4
2
0
0
2
4
6
8
10
Time
Figure 8.8
Traditional hold time validation (performing three experiments). (
See insert
for color representation of the figure
.)
Validated hold time
(Solution #2)
10
Validated hold time
(Solution #1)
8
6
4
Solution #1
Solution #2
2
0
0
2
4
6
8
10
Time
Figure 8.9
Risk-based hold time study (samples at various time points).
on testing of total number of samples may be taken on the basis of the results of
end point samples. More data points in this case would help with making batch
release decisions when the hold time exceeds the NOR and for determining the
rate and trend with time. For example, the product should be rejected when a time
of 5 h is exceeded for solution #2 as a significant measurable decline occurred
after 5 h. However, the hold time may be extended for solution #1 for up to 10
h based on solution stability (i.e., lack of decline in the trend line). This risk-
based approach provides more information about the solution behavior with time
compared to the traditional method.
8.7.6 Risk Prioritization in Large-Scale Experiments
Running commercial-scale experiments is expensive and requires considerable
plant time and resources. RAs can be used to identify the processing parameters
that pose the highest risk to product quality [26]. Given here are the steps for
risk prioritization for commercial-scale experimental design at sterile fill/finish
and packaging operations.
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