2013 pda objectionable microorganisms for nonsterile ... · the team would like to recognize john...
TRANSCRIPT
2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products
www.pda.org/bookstore
PDA Survey2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic ProductsISBN: 978-0-939459-66-7
© 2014 Parenteral Drug Association, Inc.
All rights reserved.
www.pda.org/bookstore
PDA Objectionable Microorganisms Survey Team Members
Donald English, Avon, (Chair)
Anthony Cundell, Ph.D., Merck
David Roesti, Ph.D., Novartis
Dona Reber, Pfizer
Anil Sawant, Ph.D., Johnson & Johnson
Scott Sutton, Ph.D., Consultant
Acknowledgement
The team would like to recognize John Krowka, Ph.D., Personal Care Products Council, for distributing the survey throughout his network in order to help us broaden the scope of responses beyond pharmaceutical microbiology.
www.pda.org/bookstore
Table of Contents
INTRODUCTION 1
GENERAL DEMOGRAPHICS 2
MICROBIAL TESTING OF NONSTERILE PRODUCT FORMULATIONS 6
PURIFIED WATER SYSTEMS 10
CLEANING AND SANITIZATION OF NONSTERILE MANUFACTURING EQUIPMENT 14
MICROBIAL CONTENT TEST METHODS 15
RAPID MICROBIAL TEST METHODS 21
IDENTIFICATION TEST METHODS OF RECOVERED MICROBIAL ISOLATES 24
MICROBIAL ACCEPTANCE CRITERIA FOR NONSTERILE FINISHED PRODUCT FORMULATIONS 29
TYPES OF MICROORGANISM CONSIDERED AS OBJECTIONABLE IN NONSTERILE PRODUCT FORMULATIONS 31
RISK FACTORS ANALYSIS 34
MICROBIAL TEST SPECIFICATIONS 42
STEPS TAKEN IN PREVENTING THE ISOLATION OF OBJECTIONABLE MICROORGANISMS 46
FEEDBACK FROM SURVEY RESPONDENTS CONCERNING WHICH MICROBIAL SPECIES COULD BE CONSIDERED AS OBJECTIONABLE FOR THEIR COMPANY PRODUCED NONSTERILE FINISHED PRODUCT FORMULATIONS 47
www.pda.org/bookstore