Friday, 7 June 2013

Contamination Control in Healthcare Product Manufacturing

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