Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial Fermentations - The authors outline qualification procedures for a process-critical piece of equipment

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Considerations in Identification and Qualification of Spectrophotometer Equipment for Microbial Fermentations
The authors outline qualification procedures for a process-critical piece of equipment.


BioPharm International
Volume 24, Issue 5, pp. 27-35

CONCLUSIONS

The instrument linear range using NIST OD standard solutions was higher than that observed for the process linear range for all spectrophotometers. Therefore, a conservative linear range based on the process linear range was set for each spectrophotometer. Models A, B, and C had a linear range of 0.2–4.0 dilution OD and the Model D had a reduced linear range of 0.2–1.6 dilution OD.

Model B was the most accurate and most precise spectrophotometer relative to the Model A spectrophotometer over the linear range of 0.2–4.0 dilution OD. No correction factor was required for this spectrophotometer.

Model C had high precision but reduced accuracy across the linear range compared to Model B when predicting the Model A OD. Therefore, this spectrophotometer would require a correction factor or a reduced linear range to be used as a replacement in fermentation processes.

Model D did not have sufficient accuracy or precision relative to Model A OD, and was not desirable as a replacement spectrophotometer.

ACKNOWLEDGMENTS

The authors would like to thank Bill Wagner for troubleshooting and experimental design support, and Valerie Pferdeort for assisting with sample analysis during experiments.

Carin Gray* is a senior associate scientist, Rick Burdick, PhD, is principal quality engineer, and Arun Tholudur, PhD, is principal engineer, all at Amgen, Longmont, CO,
.

REFERENCE

1. J. Neter et.al., Applied Linear Statistical Models, Fourth Edition, (McGraw Hill/Irwin 1996) pp. 167–169.


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