2013 PDA Objectionable Microorganisms for Nonsterile ... · The team would like to recognize John Krowka, Ph.D., Personal Care Products Council, for distributing the survey throughout

2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products

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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.

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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.

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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

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