A
new PDA / DHI book of interest has been published. The book is titled ‘Contamination
Control in Healthcare Product Manufacturing, Volume 1’ and it has been edited
by Russell Madsen, Jeanne Moldenhauer.
The
description for the book reads:
“Contamination
Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E.
Madsen and Jeanne Moldenhauer, is primarily focused on microbiological
contamination and the methods used to monitor and control
it, a secondary focus looks at chemical contamination that may result from the
use of cleaning and disinfecting agents. There is something for almost everyone
who has responsibility for developing or using microbiological contamination
control programs and systems.
In
this first book of the contamination control series, you will be provided with
a wealth of information that can aid you in understanding the sources of
contamination, types of control measures that can be used, methods to use when
contamination occurs and regulatory expectations for management of these
systems.”
The
chapters which make up the book, written by leading industry experts, are:
1.Introduction
by Russell E. Madsen and Jeanne Moldenhauer
2.The
Contamination Control Plan in Facility Validation by Scott Sutton
3.Facility
Design and Control: Materials and Design by Gary Devloo
4.Facility
Design and Control: HVAC by John Pinto
5.Facility
Design and Control: Personnel by Anne Marie Dixon
6.Facility
Design and Control: Cleaning and Sanitization by Anne Marie Dixon
7.Single-Use
Systems for Contamination Control by Maik W. Jornitz
8.Selecting
an Appropriate Process Cleaning Detergent by Mark Compo
9.Disinfectant
Qualification by Ziva Abraham
10.Environmental
Monitoring for Non-Sterile Operations by Miriam Rozo
11.Fungal
and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol
Bartnett and Dan Klein
12.Microbial
Control: Mold by Brian G. Hubka
13.Sterility
Test Failure Investigations by Jeanne Moldenhauer
14.Endotoxins
by Karen Zink McCullough
15.An
Audit Approach to Address Microbial Contamination in Process Equipment by Paul
Lopolito and Elizabeth Rivera
16.Impact
of Biofilms in Contamination Control by Lucia Clontz
17.Deviations
and Investigations by Frank Settineri
18.Contamination
Control Risk Assessment by Tim Sandle
19.The
Role of In-House Microbial Isolates in Contamination Control by Robert Westney
For
further details about the publication, see the PDA.
Posted by Tim Sandle