Descrição
CONTENTS:
Introduction by Russell E. Madsen and Jeanne Moldenhauer
The Contamination Control Plan in Facility Validation by Scott Sutton
Facility Design and Control: Materials and Design by Gary Devloo
Facility Design and Control: HVAC by John Pinto
Facility Design and Control: Personnel by Anne Marie Dixon
Facility Design and Control: Cleaning and Sanitization by Anne Marie Dixon
Single-Use Systems for Contamination Control by Maik W. Jornitz
Selecting an Appropriate Process Cleaning Detergent by Mark Compo
Disinfectant Qualification by Ziva Abraham
Environmental Monitoring for Non-Sterile Operations by Miriam Rozo
Fungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein
Microbial Control: Mold by Brian G. Hubka
Sterility Test Failure Investigations by Jeanne Moldenhauer
Endotoxins by Karen Zink McCullough
An Audit Approach to Address Microbial Contamination in Process Equipment by Paul Lopolito and Elizabeth Rivera
Impact of Biofilms in Contamination Control by Lucia Clontz
Deviations and Investigations by Frank Settineri
Contamination Control Risk Assessment by Tim Sandle
The Role of In-House Microbial Isolates in Contamination Cotrol by Robert Westney
