This book focuses on the design procedures that minimize the likelihood of error. It also explains how to design the laboratory facility to maximize the ability of staff to get their work done in an efficient and effective manner by describing the best practices available for design planning, technical proficiency and careful data analysis.
The goal of the book is to provide help to those who are interested in learning the perspectives of industry leaders, to better organize the microbiology lab, to meet the corporate needs as well as reflect the organization not only in the facility but in the laboratory procedures and training.
This book is unique in looking at the question of lab
design from a purely microbiological perspective and offers concrete direction
to setting up your systems and facilities to minimize errors and data
Book written in July, 2010
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 6.75 MB)
Table of Contents:
Click here to download>>>Detailed Table of Contents
1. The Role of Microbiology in a
Pharmaceutical Quality Program by Anthony M. Cundell
Issues in the Microbiology Laboratory by Roger Dabbah
Systems for the QC Microbiology Laboratory by Lucia Clontz
Laboratory Investigations of Microbiological Data Deviations (MDD) by Scott
5. Training Personnel in the Microbiology Laboratory by
Michele M. Conway
6. Safety Considerations in the Quality Control
Microbiology Laboratory by Scott Sutton
7. Microbiological Quality
for the 21st Century by Linda Skowronsky
8. Design and Layout of the
Microbiology Lab by William M. Bennett
9. Building and Equipping a
Microbiology Laboratory: How to Budget Size and Cost by Bob Ferer and
10. Laboratory Water by T. C. Soli
Culture Facility — Procedures and Facility Design by Scott
12. The Media Kitchen: Preparation and Testing of Microbiological
Culture Media by Tim Sandle
13. Environmental Monitoring of
Microbiology Laboratories by Frank Settineri
14. The Laboratory
Design and Layout for Microbial Identification by Anthony M.
15. Microbiology Manufacturing Support Laboratory by David
16. Building or Remodeling a Laboratory for the Bacterial
Endotoxin Test by Karen Zink McCullough
About the Author
Dr. Scott Sutton earned his B.S. in Genetics from the
University of California at Davis, and his Masters and Ph.D. in Microbiology
from the University of Rochester (Rochester, NY). After an NIH postdoctoral
fellowship at the Medical College of Virginia (Richmond, VA), he went to work
for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at
Alcon Laboratories (Fort Worth, TX). Dr. Sutton left Alcon Laboratories in 2004
as a Director in the R&D division to accept a position as Pharma Consultant
(Microbiology) with Vectech Pharmaceutical Consultants, Inc which he left in
2009 as Sr. Director, Microbiology Services.
Scott Sutton is the
Principal of Microbiology Network, Inc a company he started in 1996 as a means
to encourage training and communications within the microbiological community.
He is a recognized consultant and trainer with emphasis in GMP, investigations,
Environmental Monitoring and contamination control (both Aseptic manufacturing
and non-sterile production facilities) and microbiology laboratory audits and
operations. The Microbiology Network supplies consulting, training, webinars and
Email discussion groups (PMFList, PSDGList and C-CEList) Dr. Sutton is an active
author and speaker for the industry, supports PDA and has served with the USP
Analytical Microbiology Committee of Experts since 1993.