Microbial Growth and the Relationship with Culture Media. 39 ... THE MEDIA KITCHEN AND THE PREPARATION .... Objectives of a Media Simulation Trial. 368.
MICROBIOLOGICAL CULTURE MEDIA A COMPLETE GUIDE FOR PHARMACEUTICAL AND HEALTHCARE MANUFACTURERS
Tim Sandle www.pda.org/bookstore
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Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers
Tim Sandle
PDA Bethesda, MD, USA
DHI Publishing, LLC River Grove, IL, USA
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10 9 8 7 6 5 4 3 2 1 ISBN: 978-1-942911-15-9 Copyright © 2018 Tim Sandle All rights reserved. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system or transmitted in any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States 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 or otherwise, is made by reference to any such marks in the book. Websites cited are current at the time of publication. The author has made every effort to provide accurate citations. If there are any omissions, please contact the publisher. While every effort has been made by the publisher and the author to ensure the accuracy of the information expressed in this book, the organization accepts no responsibility for errors or omissions. The views expressed in this book are those of the author and may not represent 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, Gasch Printing, is a member of the Green Press Initiative and all paper used is from SFI (Sustainable Forest Initiative) certified mills. PDA Global Headquarters Bethesda Towers, Suite 600 4350 East-West Highway Bethesda, MD 20814 United States www.pda.org/bookstore 001-301-986-0293
Davis Healthcare International Publishing, LLC 2636 West Street River Grove IL 60171 United States www.DHIBooks.com
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CONTENTS
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APPLICATIONS OF CULTURE MEDIA IN PHARMACEUTICAL AND HEALTHCARE MICROBIOLOGY
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Introduction Microbiological Culture Media Structure of the Book Summary References
1 2 3 12 12
HISTORY AND DEVELOPMENT OF MICROBIOLOGICAL CULTURE MEDIA
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Introduction Origins From Laboratory to Mass Production The 20th Century: Further Advances Continuing Developments Summary References
15 16 22 25 27 30 31
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Microbiological Culture Media THE SCIENCE OF CULTURE MEDIA
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Introduction Microbial Growth and the Relationship with Culture Media Divisions of Culture Media Different Types of Culture Media Other Divisions of Culture Media Fungal Agar Future Directions for Culture Media Summary References
37 39 52 53 57 63 64 65 67
COMMON TYPES OF MICROBIOLOGICAL CULTURE MEDIA FOR PHARMACEUTICAL MICROBIOLOGY
73
Introduction Supply of Culture Media Types of Culture Media used in Pharmaceutical Microbiology Summary References
73 75 76 99 99
THE MEDIA KITCHEN AND THE PREPARATION OF MICROBIOLOGICAL CULTURE MEDIA Introduction The Media Kitchen Design of the Facilities Utilities Water Steam Quality and Autoclave Operation Incoming Materials Media Manufacture Labeling Secondary Sterilization Media Quarantine and Release Storage and Expiry Disposal Documentation Troubleshooting Conclusion References
103 103 105 106 107 107 108 110 112 119 119 119 123 123 124 124 125 126
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STERILIZATION OF MICROBIOLOGICAL CULTURE MEDIA Introduction Sterilization of Culture Media Agar Melting Summary References
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129 130 139 147 148
QUALITY CONTROL OF CULTURE MEDIA
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Introduction When Should Quality Control Testing be Performed? Physical Characteristics Undertaking Growth Promotion Testing Repeatability and Reproducibility Release of the Tested Medium Expiry Time Assessments Transportation Studies Disposal of Media Summary References
151 152 155 158 172 177 177 180 181 181 182
MICROBIAL CULTURES
187
Introduction Microbial Growth Microbial Culture Microbial Culture Collections Health and Safety Considerations for Handling Microbial Cultures Summary References
9
129
187 188 194 204 205 213 213
THE USE OF ENVIRONMENTAL ISOLATES IN PHARMACEUTICAL MICROBIOLOGY
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Introduction Why Include Environmental Isolates? Application of Environmental Isolates Arguments for the Inclusion of Environmental Isolates Arguments Against the Inclusion of Environmental Isolates How to Select Environmental Isolates? Types of Organisms to Include
219 220 223 224 225 227 230
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Microbiological Culture Media How Many Organisms Should be Included? Points to Consider When Using Environmental Isolates Summary References
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THE COLONY FORMING UNIT Introduction What is the Colony Forming Unit? Formation of the Colony Forming Unit The CFU: Single or Multiple Organisms? Calculating CFUs Reporting CFUs Practical Applications of the CFU Summary References
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MICROBIAL IDENTIFICATION AND VISUAL ASSESSMENT OF COLONIES Introduction When Visual Identification? When is it Appropriate and when is it Inappropriate Approaching Visual Identification Performing Visual Identification Schematic for Visual Identification Checklist Summary References
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QUALIFICATION OF CULTURE-BASED ENVIRONMENTAL MONITORING METHODS Introduction General Considerations Settle Plates Considerations for the Use of Active Air-Samplers Surface Methods: Swabs and Contact Plates Example of Surface Validation: Swab Recovery Contact Plates A Risk Assessment Approach to Environmental Monitoring Methods Rapid Microbiological Methods
233 234 235 236
241 241 242 245 247 249 250 251 260 261
265 265 266 268 270 277 279 280 280
283 283 285 288 296 300 301 306 307 312
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Summary References
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INCUBATION STRATEGIES FOR ENVIRONMENTAL MONITORING Introduction Temperatures of Incubation and Microbial Recovery General Purpose Culture Media Incubation Strategies Incubation Time Summary References
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CULTURE MEDIA FOR STERILITY TESTING Introduction Culture Based Sterility Test Methods (Pharmacopeial Methods) Culture Media used for the Sterility Test Media Used for the Test for Sterility Media Used for Environmental Monitoring Manufacture of Culture Media Quality Control of Culture Media Summary References
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CULTURE MEDIA FOR MEDIA SIMULATION TRIALS Introduction Defining a Media Simulation Trial Objectives of a Media Simulation Trial Types of Culture Media Preparation of Culture Media Incubation of Filled Media Units Inspection of Media Containers Laboratory Confirmation of Media Suitability Environmental Monitoring Investigating Media Fills Media Residues and Cleaning Validation Summary References
321 321 324 325 325 336 337 338
343 343 344 347 349 352 354 355 362 363
365 365 367 368 373 377 377 378 379 379 380 380 381 381
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Microbiological Culture Media
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CULTURE MEDIA FOR MICROBIAL CONTROLS DURING PHARMACEUTICAL MANUFACTURE Introduction Risks of Microorganisms During Pharmaceutical Manufacture Microbiological Examination of Non-sterile Products: Total Viable Aerobic Count Total Viable Count Method Validation Sample Preparation Microbiological Assay of Antibiotics Antibiotic Turbidimetric Assays Antimicrobial Preservative Efficacy Testing Culture Media for Microbial Identification Summary References
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ASSESSMENT OF CULTURE MEDIA FOR WATER TESTING Introduction Cultural Methods Rapid Microbiological Methods for Water Analysis References
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CULTURE MEDIA FOR CELL CULTURE WORK Introduction Brief History of Cell Culture Starting a Cell Culture Maintaining Cell Cultures Cell Culture Media Contamination of Cell Culture Media and Maintaining Medium Quality Summary References
383 383 383 385 387 389 398 401 401 405 407 407
409 409 410 423 426
431 431 432 433 434 434 436 442 442
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DILUENTS AND NEUTRALIZERS REQUIRED FOR THE PHARMACEUTICAL MICROBIOLOGY LABORATORY Introduction Sterility Testing Antimicrobial Effectiveness Test Disinfectant Testing Neutralizers Added to Culture Media Release Testing Summary References
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DATA INTEGRITY, COMPUTERIZED SYSTEMS AND MICROBIOLOGICAL CULTURE MEDIA Introduction Data Integrity Definitions of Data Importance of Microbiological Data Regulatory Findings Variability and Microbiological Data Key Factors for a Robust Data Integrity System Controls for Manual Systems Computerized Systems Barcoding Environmental Monitoring Software Automated Colony Counters Computerized System Risk Assessment Summary References
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AUDITING CULTURE MEDIA SUPPLIERS Introduction Culture Media Manufacture Quality Standards The Audit Process Scope of Audits Key Focal Points for Auditing Culture Media Manufacturing Facilities Post-Tour and the Examination of Specific Areas in Further Detail Summary References
445 445 446 449 451 453 453 455 455
459 459 460 462 464 465 466 467 469 472 474 474 475 479 487 487
489 489 490 492 494 495 503 510 510
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Microbiological Culture Media
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INDUSTRY PRACTICES RELATING TO CULTURE MEDIA USE Introduction About the Study Survey Results Summary References
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513 514 514 538 538
GROWTH AND CULTURE BASED RAPID MICROBIOLOGICAL METHODS Introduction Changing World of Microbiology Advantages of Rapid Methods Regulatory Acceptance Types of Rapid Microbiological Methods Growth-based Methods Selection of Rapid Microbiological Methods Summary References
INDEX
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541 541 543 545 547 547 548 552 562 563
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About the Book This book is about microbiological culture media as applied to pharmaceutical microbiology. The central aim of this book is to look at how media is used in the modern pharmaceutical microbiology setting. It takes into account that innovations continue to arise with new media recipes being formulated for the selection of new strains to the application of media in conjunction with rapid microbiological methods. To do this requires an acknowledgement of the outcomes of the human microbiome research, which highlight that the vast extent of the microbial world is non-culturable; and an understanding of how rapid and alternative microbiological methods are altering the approach to testing and assessment. Tim Sandle takes into account the fact that 90 percent of quality control microbiology remains reliant upon culture based methods. While the core pharmacopeia tests remain culture-dependent and many of the emergent rapid methods are culture-based as well, it also stands that reviews of the seemingly well understood (how to undertake growth promotion testing, for instance) and the less well understood (determining the incubation parameters for environmental monitoring, for example) are needed. This unique text is dedicated to the use of culture media in the pharmaceutical microbiology setting and recaps the past, signals the future, and helps interpret the present. About the Author Dr. Tim Sandle is Head of Microbiology at Bio Products Laboratory, UK and visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. He serves on several national and international committees related to pharmaceutical microbiology and cleanroom contamination control including Pharmig and PDA technical working groups. He is a member of several editorial boards, the author of over 500 book chapters, peer-reviewed technical articles and several books published including Aseptic and Sterile Processing co-edited with Edward C. Tidswell co-published by PDA and DHI Publishing.
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