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Cosmetic Microbiology A Practical Approach Third Edition Edited by Philip A. Geis Geis Microbiological Quality, Affiliated with Advanced Testing Laboratory, The Villages, Florida Third edition published 2021 by CRC Press 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487- 2742 and by CRC Press 2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN © 2021 Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, LLC This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author(s) nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors, or contributors are personal to them and do not necessarily reflect the views/ opinions of the publishers. 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ISBN: 978- 1- 138- 73357- 2 (hbk) ISBN: 978- 0- 429- 11369- 7 (ebk) Contents Preface ........................................................................................................................................................v About the Editor ........................................................................................................................................vi List of Contributors ..................................................................................................................................vii 1. Basic Microbiology ............................................................................................................................1 Peter J. King 2. Preservatives and Preservation.......................................................................................................15 Philip A. Geis 3. Natural Preservatives ......................................................................................................................31 Terry L. Amoroso 4. Multifunctional Ingredients ............................................................................................................45 Steven F. Schnittger 5. Preservative Resistance ...................................................................................................................53 Donald J. English 6. Antimicrobial Preservative Efficacy and Microbial Content Testing .........................................67 Scott V.W. Sutton with Philip A. Geis 7. Rapid Methods in Cosmetic Microbiology ....................................................................................95 Michael J. Miller 8. Prevention of Microbial Contamination during Manufacturing ..............................................113 Donald J. English 9. Microbial Monitoring of a Manufacturing Facility ....................................................................143 Donald J. English 10. Hazard Analysis and Critical Control Point (HACCP) Protocols in Cosmetic Microbiology ..................................................................................................................157 Laura M. Clemens and Harry L. Schubert 11. Manufacturing Microbiology—A View of the Future ................................................................165 Neil J. Lewis 12. Consumer Safety Considerations of Cosmetic Preservation .....................................................181 Corie A. Ellison, Alhaji U. N’jai, and Donald L. Bjerke 13. Global Regulation of Preservatives and Cosmetic Preservatives ..............................................195 David C. Steinberg Index ......................................................................................................................................................207 iii To parents Bob and Virginia, mentors Flavin and Paul—and to Carol. Preface In the context of corporate entities, the cosmetic industry was born in the early 20th century with companies such as the California Perfume Company (Avon) and the Safe Hair Dye Company of France (L’Oreal). Concern for microbiological quality followed soon after with efforts to reduce contamination risks using preservative parabens and benzoic acid as well as product pasteurization. Formaldehyde preservation was applied largely in the 1930s with the development of synthetic shampoos. Though attention to the quality of the cosmetic product category in the United States was addressed in the Federal Food, Drug, and Cosmetic Act of 1936, cosmetic microbiological quality received little regulatory attention until after World War II. At that time, manufacturing quality and preservation were clearly insufficient to ensure microbiological quality in the context of greatly ramped-u p production to satisfy the demands of post- war economies. Shelf surveys in the United States and Europe found that up to 40% of the products on shelves were heavily contaminated with bacteria and fungi. With the additional realization of consumer contamination of products during use came heightened regulatory attention, including development by the FDA (Food and Drug Administration) of methods for preservative testing. Through the latter half of the 20th century, the cosmetic industry prioritized microbiological quality. Hygienic manufacturing guidelines and methods for finished product quality and preservative efficacy testing and package design were developed and codified in compendia such as the CTFA (Cosmetics, Toiletries, and Fragrance Association) Guidelines. Development and application of new preservatives profoundly expanded the stable of useful chemicals during this period with the introduction of organic alcohols, formaldehyde releaser, and isothiazolinone preservatives. These critical quality elements were developed, documented, and applied by a small group of industrial microbiologists whose arcane expertise established decades of excellent microbiological quality and consumer safety as recognized by industry and regulators. With the dawn of the 21st century came increasing consumer interest and demand for “green” products. This growing category niche is characterized by rejection of traditional preservative systems, including parabens and formaldehyde preservatives, and conversion to alternative preservative systems, especially the so called natural preservatives. These alternative preservative systems have been applied often without adequate understanding of accompanying contamination risks. In recent years, this lack of understanding of risk has led to compromised product quality. Although major marketers invested efforts in the development of compliant products and found alternative systems to be feasible, most found the accompanying compromise in preservative efficacy insufficient to satisfy business demands and risk assessment protocols especially as applied to short- cycle product development and high- speed, high- volume manufacturing demands. However, many small- and medium- sized companies targeted this consumer demand. Production in the context of lesser expertise in product quality demands resulted in increased microbiological contamination-b ased recalls of cosmetics to levels not seen for many decades. Examination of relevant enforcement reports typically finds these microbiological quality excursions among smaller companies pursuing alternative preservative or preservative- free systems. Regulatory attention to these quality concerns has confirmed risks associated with application of alternative systems. The third edition of this series brings the 21st- century understanding of microbiology and the critical applied elements of cosmetic microbiological quality. Progress in the context of regulatory controls and human safety understanding, effective development and application of conventional and alternative preservative systems in this field since the last edition of this book was published is also discussed. Testing protocols too are updated and expanded to include rapid method, and hygienic manufacturing is discussed both as a quality concept and in its application and monitoring. Philip A. Geis v About the Editor Philip A. Geis is a native Texan who earned bachelor and doctor of philosophy degrees in microbiology from the University of Texas. His career in microbiology began in the US Army, which awarded him the Army Medal of Commendation for his service to its 45th Field Hospital. Geis subsequently worked in commercial media production and joined the Procter & Gamble Company (P&G) following graduate school. Through three decades with P&G, Geis managed global preservative and disinfectant development, studies of household and skin microbial ecologies, and hygienic manufacturing. He was the first recipient of P&G’s namesake award—Dr. Philip Geis Microbiology Quality Award. While at P&G, he also carried responsibilities for state and federal regulatory compliance and policy matters as well as formulation and product development for which he is co- inventor for a number of domestic and international products. Geis published, lectured, and represented P&G’s technical interests on subjects of applied microbiology and environmental policy. He edited the second edition of Cosmetic Microbiology: A Practical Handbook and served as trustee of the Ohio Academy of Science, chairing its Science Policy Committee. In 2011, Geis retired from P&G, establishing Geis Microbiological Services in affiliation with Advanced Testing Laboratory. His domestic and international clients range from the French Ministry of Culture to Dow 50 companies. He currently serves as the editor of the journal International Biodeterioration and Biodegradation journal and as instructor at the Microbiology and Cell Science department at the University of Florida. Dr. Geis possesses unique global expertise and experience in diverse regulatory, manufacturing, and product quality disciplines and knowledge of consumer preferences for a broad range of products from OTC (over- the- counter) drugs to fabric softeners to dog food and cultural/ historic properties. vi newgenprepdf Contributors Terry L. Amoroso, PhD, Director, Corporate Quality Assurance, The Procter & Gamble Co., Mason Business Center, Mason OH Donald L. Bjerke, PhD/D ABT, Global Product Stewardship, The Procter & Gamble Co., Mason Business Center, Mason, OH Laura M. Clemens, BS, Regional Industrial Microbiologist, The Procter & Gamble Co., Swisher, IA Corie A. Ellison, PhD, The Procter & Gamble Co., Cincinnati, OH Donald J. English, MS, Donald J. English Microbiological Quality Consulting LLC, Florham Park, NJ Peter J. King, PhD, College of Natural Sciences, University of Texas at Austin, Austin, TX Neil J. Lewis, BS, Global Technical Leader, Microbiology Delivery, The Procter & Gamble Co., Mason Business Center, Mason, OH Michael J. Miller, PhD, Microbiology Consultants, LLC, Lutz, FL Alhaji U. N’jai, PhD, Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin- Madison, Madison WI Steven F. Schnittger, MS, Vice President, Global Microbiology and Fermentation, The Estée Lauder Companies Inc., Melville, NY Harry L. Schubert, BS, Retired, Sardinia, OH David C. Steinberg, BS, MBA, FRAG, Steinberg & Associates, Inc., Pompton Plains, NJ Scott V.W. Sutton, PhD, deceased vii newgenprepdf 1 Basic Microbiology Peter J. King Introduction to Microbiology .....................................................................................................................1 The Prokaryotes .........................................................................................................................................1 The Bacteria ...............................................................................................................................................2 The Fungi .................................................................................................................................................11 Common Contaminants in the Cosmetics Industry .................................................................................12 References ................................................................................................................................................14 Introduction to Microbiology This chapter will serve as a primer for those new to microbiology and as an updated reference for those familiar with the science. The discipline of microbiology has advanced rapidly since the refinement of Galileo’s light microscope by Van Leeuwenhoek (1674), the disproving of spontaneous generation by Pasteur (1861), the elucidation of the links between specific microbes and human diseases by Koch (1876), and the discovery of viruses by Ivanovsky and Beijerinck (1892). The rate of discovery since the early 1800s represents a mirror of the development of the microbiological techniques used to culture, identify, and characterize microorganisms of all classes. Collectively, the combination of microbiologic techniques and the resulting description of the properties of microbes led to the evolution of impactful techniques of detection of microbes and development of methods for the prevention and treatment of human infectious diseases. While modern microbiology focuses on bacteria (living prokaryotic organisms) and viruses (non- living biologic entities), prions (infectious proteins), protozoa (unicellular eukaryotes), fungi (unicellular and multicellular eukaryotes), and helminths (multicellular eukaryotic worms) are generally studied under the microbiology umbrella. This chapter will focus on bacteria and fungi and the methods to detect the presence of bacterial and fungal organisms. The Prokaryotes All living cells on the planet can be separated into having either a eukaryotic or a prokaryotic cell structure. Prokaryotes (“before the nucleus”) have a simple cell structure comprising a cell membrane and an internal fluid environment called the cytosol. Eukaryotic cells (“true nucleus”) have these components as well as multiple membrane- enclosed “organelles” evolved for specific functions just like the nucleus. While eukaryotes can be subdivided into plant-l ike and animal- like cell types, extant prokaryotes can be classified into two major phylogenetic groups based on genomic sequencing, specifically that of 16S ribosomal RNA (rRNA) genes (Figure 1.1) (1). The first prokaryotic group, which appears to have given rise evolutionarily to eukaryotic cells, belongs to the domain Archaea, the archaebacteria. These organisms appear to represent more ancient forms of prokaryotic cells, many of which evolved to occupy extreme niches such as hydrothermal vents and extreme acid and alkali environments. Although these organisms are fascinating due to their mechanisms of adaptation to these environments and their 1