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

ADVERTISEMENT

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here