Download - Pda book table of contents-environmental monitoring a comprehensive handbook volume 7-2015

www.pda.org/bookstore

ENVIRONMENTALMONITORING

A Comprehensive Handbook

JEANNE MOLDENHAUEREditor

Volume Seven

PDABethesda, MD, USA

DHI Publishing, LLCRiver Grove, IL, USA

01Front Matter:FrontMatter 11/12/14 19:19 Page 1


10 9 8 7 6 5 4 3 2 1

ISBN: 1-933722-85-1Copyright © 2015 J. MoldenhauerAll rights reserved.

All rights reserved. This book is protected by copyright. No part of it may be reproduced, storedin a retrieval system or transmitted in any means, electronic, mechanical, photocopying,recording, or otherwise, without written permission from the publisher. Printed in the UnitedStates of America.

Where a product trademark, registration mark, or other protected mark is made in the text,ownership of the mark remains with the lawful owner of the mark. No claim, intentional orotherwise, is made by reference to any such marks in the book. The authors have made everyeffort to provide accurate citations. If there are any omissions, please contact the publisher.

While every effort has been made by the publisher and the authors to ensure the accuracyof the information expressed in this book, the organization accepts no responsibility for errorsor omissions. The views expressed in this book are those of the editors and authors and may notrepresent those of either Davis Healthcare International or the PDA, its officers, or directors.

This book is printed on sustainable resource paper approved by the Forest Stewardship Council. The printer, GaschPrinting, LLC, is a member of the Green Press Initiative and all paper used is from SFI (Sustainable Forest Initiative)certified mills.

PDA Davis Healthcare International Publishing, LLC4350 East West Highway 2636West StreetSuite 200 River GroveBethesda, MD 20814 IL 60171United States United Stateswww.pda.org/bookstore www.DHIBooks.com001-301-986-0293

01Front Matter:FrontMatter 11/12/14 19:19 Page 2


CONTENTS

Introduction xiii

CLEANROOMS AND PREVENTING CONTAMINATION

1 INTRODUCTION TO CLEANROOM DESIGNAND OPERATION 3Tim SandleIntroduction 3Cleanrooms 3

Clean air devices 5Cleanrooms and Contamination Control 6

Risk assessment 10Cleanroom Classification 10

Particle counting 16Cleanroom Operational Parameters 17

Air filtration 18Air-patterns and air-movement 19Airflow velocity and direction 20Air changes 20Clean up times 21Separation concept and positive pressure differentials 21Other factors 21

iii

02Contents:Layout 1 11/12/14 19:38 Page iii (Black plate)


Cleanroom Design 22Energy saving 22

Cleaning and Disinfection 22Environmental Monitoring 23Auditing 24Conclusion 25References 26About the Author 27

2 PROTECTING CLEANROOMS FROM CONTAMINATION 29Jeanne MoldenhauerIntroduction 29Types of Particulates 29Size of Particulates 30Recommended Practices 31Cleanroom Standards 32Cleanroom Design 33Cleaning and Disinfection 34Preventative Maintenance 34Good Housekeeping Practices 35Clean in Place, Steam in Place, Sterilize in Place Systems 35Humans are the Biggest Source of Contamination 35Cleanroom Garments 37Personnel Behaviors 37Cleanroom Personnel and Smoking 38Conclusion 39References 39About the Author 41

3 CLEANROOM GOWNING AND GOWNING CERTIFICATION 43Jan EudyIntroduction 43A Short Course in Particulation 43Facility Design 44Human Sourced Contamination 46Behavior 47Cleanroom Garments 48Fabric and Findings 49Type, Style and Construction of Garments 50Garment Cleaning Process 51Testing of Cleanroom Garments 52Sterile Cleanroom Garments 55Gamma Subcontractor Qualification 56Routine Monitoring of Gamma Radiation 56

Environmental Monitoringiv

02Contents:Layout 1 11/12/14 19:38 Page iv (Black plate)


Certificate of Sterility 56Gowning for the Cleanroom 57Sterile Gowning Procedure for ISO Class 3–5/Class A Cleanrooms 57

Donning 57Doffing 58

Non-Sterile Gowning Procedure for ISO Class 3–5 Cleanrooms 58Donning 58Doffing 59

Gowning Procedure for Frocks in ISO Class 6–8 Cleanrooms 59Donning 59Doffing 60

Gowning Certification 60Summary 61References 61About the Author 63

4 CLEANING AND DISINFECTING CLEANROOMS 65Jim Polarine, Elaine Sartain, and Carol BartnettIntroduction 65Disinfectant Selection 66References 72About the Authors 73

5 STERIPLEX,A NEW SILVER-BASED DISINFECTANT— NON-CORROSIVE, NON-TOXIC, SPORICIDAL:DISINFECTANT EFFICACY EVALUATIONS 75John M. LindsaySummary 75Introduction 76Materials and Methods 77

Neutralizer broth 77Procedures 78Results 83

In Situ Evaluations 85Additional tests 86

Conclusions and Discussion 88References 89About the Author 90Attachment 1 Project Protocol 91Attachment 2 Enumeration of Challenge Microorganism Suspensions 100Attachment 3 Preparation of Steriplex Neutralizer Broth 102Attachment 4 Data Sheet for Steriplex Challenge 103Attachment 5 Pour Plate or Spread Plate Method forTotal Aerobic Microbial Count 113

Contents v

02Contents:Layout 1 11/12/14 19:38 Page v (Black plate)


6 OZONE GAS: DECONTAMINATION, SANITIZATIONAND STERILIZATION 115Brian G. Hubka and Jeanne MoldenhauerIntroduction 115What is Ozone and how does itWork? 116

Ozone generators 116Using ozone 116Ozone to inactivate microorganisms 117Safety concerns using ozone 117Concerns using ozone technology 118Ozone benefits 118

Compatibility of Ozone with Other Materials 119Using Ozone as a Sterilant 120Microbiological Aspects of Ozone Use 121Pharmaceutical Applications for Gaseous Ozone Usage 123Conclusion 123References 123About the Authors 125

7 STERILIZATION AND DECONTAMINATIONWITHNITROGEN DIOXIDE GAS 127David OpieIntroduction 127NO2 Physical Properties 127Safety 128Mechanism of Action 130

Response of microorganisms to NO2 131Inactivation kinetics 132

Cycle Parameters 133NO2 Cycle Descriptions 137

Vacuum NO2 cycles 138Non-vacuum NO2 cycles 139

Material Compatibility 139Chemical compatibility 140Biocompatibility 141Sterilizability on materials 142

Process Accessories 143Biological indicators 143Process challenge devices 144Chemical indicators 144NO2 concentration detectors 145Humidity detector 145

Applications for the NO2 Technology 145NO2 application to prefilled syringes and drug containers 145Terminal sterilization of medical devices 147

Environmental Monitoringvi

02Contents:Layout 1 11/12/14 19:38 Page vi (Black plate)


Decontamination of filling lines and isolators 148Summary 149References 149About the Author 151

ENVIRONMENTAL MONITORINGTECHNIQUESAND METHODS

8 SETTING UP AN ENVIRONMENTAL MONITORINGPROGRAM FOR CONTROLLED ASEPTIC CLEANROOMENVIRONMENTS 155Ryan Burke and Francis McAteerIntroduction 155Design and Assessment of the Cleanroom Facility 157

How does a cleanroom accomplish control? 157Determining Appropriate Sampling Methodologies 162

Environmental monitoring general overview 162How the air is sampled in a cleanroom 163How surfaces are sampled in a cleanroom 163How personnel are monitored in a cleanroom 163

Monitoring and Sampling Techniques 164Generating SOPs and Protocols 169Sampling Plan Design 170Data Management 172Establishing Alert and Action Limits 173Corrective Action and Preventative Action Process 176Importance of Maintaining and Conducting the EnvironmentalMonitoring Program Properly 177Conclusion 177References 178About the Authors 180

9 QUALITY RISK MANAGEMENT SAMPLING PLAN —A VALIDATION ENGINEERING PERSPECTIVE 181Allan MarinelliIntroduction 181PurifiedWater System 182Quality Risk Management 182Rationale for Determining the PQ Sample Points 183Conclusion 201References 201About the Author 202

Contents vii

02Contents:Layout 1 11/12/14 19:38 Page vii (Black plate)


10 PRACTICAL APPROACH ON THE EFFICIENCY OFMICROBIOLOGICAL METHODS FOR ENVIRONMENTALMONITORING 203Anne-Grit Klees and Reinder HedderichFertility: Growth Promotion Test 205Growth Promotion Tests in the Presence of Inhibitory Substances 208Overall Efficiency of Surface Sampling Methods 212References 216About the Authors 218

11 OPTIMIZING TIME-TO-RESULTS FOR ENVIRONMENTALMONITORING APPLICATIONS FOR GROWTH-BASEDRAPID MICROBIOLOGY METHODS 219Andrew SageTime-to-results and Incubation Profiles of EnvironmentalMonitoring Testing Applications 219TTR: An Important Requirement for Growth Based RapidMicro Methods 220Requirements for Performing a TTR Determination onGrowth-based RRMs 220Experimental Strategy for Optimizing Incubation and Setting TTR 221Determining Optimal Incubation Profile and TTR for EM Testingon the Growth Direct System™: An Automated, Growth-based RRM 221Optimal Incubation Regime for Detection of Bacteria and MoldSpecies on the Growth Direct System 224TTR Determination for Serial Incubation on the Growth DirectSystem andVerification Testing 228A Single Temperature Alternate Incubation Strategy may ReplaceSerial Incubation 230Summary 232References 232About the Author 234

12 REAL-TIME RISK ASSESSMENT CONTROL STRATEGY 235Sean TolerReal-time Risk Assessment Shaped from Quality by Design 235QbD Risk Assessments to Develop RTRA 237QbD Design Space Impact on RTRA 238QbD Control Strategy of RTRA 239Continuous Improvement from RTRA 241Implementing the RTRA 244Microbiologist Development for RTRA 252Cultural Improvement from RTRA 253

Environmental Monitoringviii

02Contents:Layout 1 11/12/14 19:38 Page viii (Black plate)


Summary 254References 254About the Author 256

13 ENVIRONMENTAL MONITORING OF COMPRESSED GASES 257Tim Cser and Anne ConnorsIntroduction 257Regulations and Guidance 257Uses of Compressed Gas 259Compressed Gas Testing 259Bacteria Yeast and Mold 259ISO 8573-4 Test Methods for Solid Particle Content 260ISO 8573-7 Test Method for Viable Microbiological Contaminant Content 261Alternative Viable Testing Methods 262

MAS-100 CG EX 262RCS with CG adapter 262

Results Interpretation and Data Analysis 263Investigations and Corrective Actions 263References 264About the Authors 264

14 ENVIRONMENTAL MONITORING FOR STERILITYTEST ISOLATORS 265Claire Fritz BrigliaHistory of Isolators for Sterility Testing 265The Regulations 268Installation Qualification/Operation Qualification 269Performance Qualification 269Why Establish an Environmental Monitoring Programfor a Sterility Testing Isolator? 270What to Monitor andWhat are the Methods? 271Non-viable Air 271Viable Air 272Surface Monitoring 272Glove Monitoring and Testing 274Monitoring Outside the Isolator 275When? 275Action and Alert Levels 276Culture Media for Environmental Monitoring 276Validation 277Conclusion 278References 278About the Author 279

Contents ix

02Contents:Layout 1 11/12/14 19:38 Page ix (Black plate)


CHANGES TO STANDARDS

15 TESTING AND VERIFICATION OF VENTILATIONSYSTEMS FOR BIOSAFETY LEVEL 3 (BSL-3) ANDANIMAL BIOSAFETY LEVEL 3 (ABSL-3) FACILITIES 283Farhad Memardazeh and Louis DiBerardinisIntroduction 283Definitions 285What is Laboratory Biocontainment? 286History of ANSI/ASSE Z9.14 288What is ANSI/ASSE Z9.14? 290Findings of the Gap and Needs Analysis 291

National US and local laws, standards and guidelines 292National initiatives outside the US 295International initiatives 296

ANSI/ASSE Z9.14: The Standard 297How to read the standard 297Purpose 297Scope 297Definitions 298Applicability and conformance 298Procedure for entities using the ANSI/ASSE Z9.14 Standard 299Overview 300Roles and responsibilities 302Risk assessment 303

Guidelines for Implementing Testing and Performance-Verification 305Verification 305Documentation overview 305Visual inspection 307Testing methodologies 307

References 318About the Authors 322

NEW TECHNOLOGIES FOR ENVIRONMENTALMONITORINGAND AIDS TO EVALUATING THEM

16 STRESSED MICROBIAL POPULATIONS: REAL-WORLDCHALLENGE FOR VALIDATION OF NEW APPLICATIONS 325Andrew SageImportance of Use of Stressed Microbial Populationsfor Validation Testing in Industry 325Microbes in the Environment Exist in a Stressed State 326Stress and Injury Response in Microbes 327

Environmental Monitoringx

02Contents:Layout 1 11/12/14 19:38 Page x (Black plate)


Preparation of Stressed Populations for MethodValidation 329Case study 1 Preparation of heat-injured sporesof A. brasiliensis spores 330Case study 2 Preparation of an acid-stressed populationof Pseudomonas aeruginosa 332

Using the Growth Direct™ System to Measure the Effect of StressedInduced Injury on the Growth Dynamics of Microbial Populations 332Stressed Populations Exhibit Attenuated Detection as Exemplifiedby Heat-stressed A. Brasiliensis, and Acid-injured P. Aeruginosa 336The Physiological State of a Test Organism can Influenceits Response to Stress 337Conclusion 338References 339About the Author 340

17 REAL TIME MICROBIAL ANALYZER FORWATER 341J.P. JiangTechnical Description of RMS-Water Analyzer 342Validation Test of RMS-W Using BioBall® 344

BioBall quantitative samples 344Validation Test Data and Method Descriptions 346

Ruggedness test procedure 350Miscellaneous suggestions for conducting feasibilitystudy of RMS-W instrument 351

Application Example: OnlineWater Monitoring Using RMS-W 352Example 1: RMS-W online monitoring of a high puritywater line 352Example 2: RMS-W online monitoring at a mineral waterbottling plant 353

Application Example: Surface Sampling and Cleaning Validation 355Example 1: surface sampling using RMS-W and Quantiswab® 355Example 2: cleaning validation using RMS-W and Quantiswab® 357

Summary 358References 358About the Author 359

Appendix 361

Index 371

Contents xi

02Contents:Layout 1 11/12/14 19:38 Page xi (Black plate)


02Contents:Layout 1 11/12/14 19:38 Page xii (Black plate)


INTRODUCTION

This is volume 7 of the Environmental Monitoring Handbook series. Each volume of this seriesdiscusses different aspects of environmental monitoring. The appendix describes the varioustopics and authors that can be found in volumes 1 through 6 of this series.

One of the first topics discussed in this volume is the topic of cleanrooms and ways toprevent contamination. This is important — as an industry and we are changing the paradigmfrom reacting to contamination to a mode of preventing contamination. Dr. Tim Sandleprovides a great guide to cleanrooms. This is followed by a discussion of methods to protectcleanrooms from contamination. Jan Eudy describes the methods to be used for gowning andgowning qualification to protect from contamination. Jim Polarine and his group have writtena discussion on the cleaning and disinfection of cleanrooms. As we are always looking for newand/or better ways to do things, John Lindsay has a chapter on the qualification of a newdisinfectant. This disinfectant is effective with approximately one minute of contact time! Twonew methods of contamination control: Brian Hubka discuss the use of gaseous/vaporizedozone and David Opie discusses the use of nitrous oxide.

The second section of the book describes various environmental monitoring techniquesand methods. As you have seen in various earlier volumes, Burke has a chapter on how to setup an environmental monitoring program. It is useful to look at the various different methodsindividuals have used to customize the program that will work best for your site. Another hottopic in today’s compliance arena is sampling plans. Marinelli discusses the methods to use insetting up a sampling plan for your site. Klees and Hedderich provide useful information on the

xiii

03Introduction:Layout 1 10/12/14 08:21 Page xiii (Black plate)


efficiency of microbiological methods that are used for environmental monitoring. Many timeswrong assumptions are made about the environmental data, because we don’t understand theefficiency of these methods. When using growth-based methods, a common complaint is thelong time it takes to get results. Dr. Sage has identified how to optimize the time you need toget results using these types of methods. In recent years several companies have evaluatedand/or implemented newer environmental monitoring methods that are based upon the use ofviability methods. One on-going concern with these types of methods is how you could do aninvestigation should you have a contamination event. Sean Toler describes a programimplemented that conducts real time risk assessment along with a viability-based methodology.Tim Cser explains the conduct of environmental monitoring for compressed gases and ClaireFritz-Briglia provides information on the conduct of environmental monitoring to supportsterility testing in an isolator environment.

The third section of the book deals with changes to standards. Memarzadeh andDiBerardinis explain the changes that occurred for ANSI Standard 29.14 and how this isapplicable in pharmaceutical environments.

The last section of this volume talks about new technologies and aids that can be used inevaluating these methods. Dr. Sage provides a defined program for creating and using stressedorganisms in the validation of alternative microbiological methods. Dr. J.P. Jiang explains howthe IbioScan works. This technology detects the presence of viable biological particles in watermonitoring in real time.

There is a wealth of useful information that you can use in establishing, maintaining andupdating your environmental monitoring program!

Environmental Monitoringxiv

03Introduction:Layout 1 10/12/14 08:21 Page xiv (Black plate)


Download - Pda book table of contents-environmental monitoring a comprehensive handbook volume 7-2015

Top Related