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

EMD Millipore Collaborates with PharmaCell on Large-Scale, Cell-Culture Systems
May 23, 2013
SCHOTT Introduces Cartridge Design for High-Speed Filling
May 23, 2013
Moscow Hosts IFPMA Biosimilars Conference
May 17, 2013
AbbVie and Alvine Will Collaborate on Celiac Disease Therapy
May 15, 2013
FDA Issues Pharmacoepidemiologic Safety Study Guidance
May 14, 2013
Upcoming Conferences
UPCOMING CONFERENCES

Access Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA | July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA | August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA | August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA | August 20-21, 2013
Request Brochure

See All Conferences >>

ADVERTISEMENT

Author Guidelines
FindPharma
Source: BioPharm International,
Click here