Cosmetic Microbiology: A Practical Approach

Cover
Title Page
Copyright Page
Table of contents
Dedication
Preface
About the Editor
Contributors
1 Basic Microbiology
Introduction to Microbiology
The Prokaryotes
The Bacteria
Bacterial Cell Structure
Bacterial Cell Wall
Bacterial Genetics
DNA Transfer in Bacteria
Vertical Gene Transfer
Horizontal Gene Transfer
The Genetics of Bacterial Antimicrobial and Preservative Resistance
Bacterial Metabolism
Fermentation
Major Nutritional Types of the Bacteria
The Fungi
Fungal Structure
Fungal Reproduction
Fungal Divisions
Common Contaminants in the Cosmetics Industry
Bacteria
Fungi
References
2 Preservatives and Preservation
Introduction
Scope of Preservations and Microbiological Targets of Preservation
Targets of Preservation
Rationale for Preservative Use
Chemical Preservatives
Commonly Used Cosmetic Preservatives
Preservative Combinations
Preservative Adjuncts/Helpers
Preservation during Manufacturing
Overview
References
3 Natural Preservatives
Introduction
The Need for Cosmetic Preservation
Consumer Perspective
Natural Preservative Regulation
Categories of Natural Preservatives
Botanical Extracts
Introduction
Perspectives on Use
Sustainable Application
Effective Concentrations
Major Drivers of Antimicrobial Activity
Terpenes/Terpenoids
Phenolics
Selected Botanical Extracts
Tea Tree Oil
Neem Oil
Spice/Herbal Extracts and Essential Oils
Organic Acids
Enzymes
Introduction
Lactoperoxidase and Glucose Oxidase
Antimicrobial Peptides
Final Thoughts
References
4 Multifunctional Ingredients
Introduction
Conventional Preservative Systems
Multifunctional Ingredients
Preservative Potentiators
Low-Risk Formulations
Manufacturing and Production Conditions
Microbiological Risk Assessment
Packaging and Product Protection
Conclusion
References
5 Preservative Resistance
Introduction
Mechanisms for the Development of Preservative Resistance
Enzymatic Degradation
Exposure to Sub-Inhibitory and/or Sub-Lethal Preservative Concentrations
Outer Membrane Changes
Efflux Pump
Mutation
Inhibiting the Development of Preservative Resistant Strains
Confirming the Presence of a Preservative-Resistant Microorganism
in a Product Formulation
Elimination of Preservative-Resistant Isolates from a Manufacturing Facility
Antibiotics Resistance to Preservative Resistance
Summary
References
6 Antimicrobial Preservative Efficacy and Microbial Content Testing*
Introduction
Preservative Efficacy Methods
Current Preservative Efficacy Test Methods
Preservation Efficacy Testing: General Procedure
PCPC Method
Challenge Organism Inoculum
Conducting Test
Neutralization and Recovery
ASTM Method
Challenge Organism Inoculum
Conducting Test
Neutralization and Recovery
Criteria for Passing
USP Method
Challenge Organism Inoculum
Conducting Test
Criteria for Passage
Comparison of Methods
Challenge Microorganisms
Maintenance and Harvesting of Organisms
Preparation and Standardization of Inoculum
Pure versus Mixed Cultures
Incubation Conditions, Interpretation, Rechallenge
Other Published Methods
D-Value Methods
Capacity Tests
Tests Predictive of Consumer Contamination
Tests for Factors Affecting Preservative Efficacy
Inoculum Preparation and Handling
Recovery Conditions
Plating Concerns
Neutralizer Evaluation
Functions of Neutralizers
Types of Neutralization
Chemical Neutralization
Dilution and Membrane Filtration
Methods for Testing Biocide Neutralizers
Rapid Methods Used in Preservative Testing
General Considerations for Formulating Preserved Products
Interactions of Preservatives
Water Activity
Container Considerations
Alternative Tests
Risk Assessment
Microbial Content Testing
General Product and Raw Materials Tests
USP Tests
Chapter 61—Microbial Enumeration Tests
Chapter 62—Tests for Specified Microorganisms
1111—Microbiological Contamination Limits for Nonsterile Products
Package Tests
Environmental Tests and Monitoring
Identification of Microbes
Summary
References
7 Rapid Methods in Cosmetic Microbiology
Introduction
Rapid Microbiological Methods
Applications
Implementation Strategy
Review of RMM Technologies
Growth-Based Methods
Cellular Component-Based Technologies
Viability-Based Technologies
Spectroscopic-Based Technologies
Nucleic Acid Amplification-Based Technologies
Micro-Electro-Mechanical Systems (MEMS)
Validation of RMMS
Return on Investment
Summary
References
8 Prevention of Microbial Contamination during Manufacturing
Introduction
Facility
Design and Overall Layout
Facility HVAC Systems
Air Filtration
Air Treatment
Air Exchange
Energy Conservation
Makeup Air
Floors
Types of Flooring Systems
Drains
Walls, Ceilings, Windows and Doors
Equipment Placement
Traffic and Material Flow
Manufacturing Systems
Compressed Air Systems
Design
Vacuum Systems
Process Water Systems
Overall Design Considerations
Microbial Design Considerations
Possible Sources of Microbial Contamination
Sources of Microbial Growth Requirements in Process Water
Microbial Contamination in Process Water Systems
Reasons for Microbial Contamination Issues in Process Water System Components
Microbial Control Measures
Microbial Control Methods
Equipment
Sanitary Design Considerations
Types of Equipment
Processing Tanks/Vessels/Mixers
Valves
Pumps
Storage Vessels
Filters, Strainers and Sieves
Transport Piping
Piping Joints
Gaskets
Hoses
Filling Equipment
Gauges and Meters
Cleaning and Sanitization
Cleaning
Considerations for Cleaning
Equipment Surface Considerations
Application Cleaning Methods
Types of Cleaning Equipment Procedures
Cleaning Equipment and Systems
Selection of Cleaning Agents
Validation of Cleaning Procedures
Cleaning Acceptance Criteria
Cleaning Operator Training
Sanitization
Types of Chemical Sanitizers
Types of Physical Sanitizers
Considerations for Sanitization
Sanitization Acceptance Criteria
Sanitization Process Operator Training
Rotation of Sanitizers
Summary
References
9 Microbial Monitoring of a Manufacturing Facility
Introduction
Microbial Air Monitoring
Air Sampling Methods
Location, Frequency, and the Number of Air Sampling Sites
Alert and Action Levels
Identification of Recovered Air Microbial Isolates
Microbial Monitoring of the Facility
Floors
Walls and Ceilings
Microbial Monitoring of Manufacturing Systems
Compressed Air
Process Water
Water Sampling
Enumeration Methods
Identification of Recovered Microbial Isolates
Alert and Action Levels
Microbial Monitoring of Equipment Surfaces after Sanitization
Sampling Methods
Direct Contact Method
Swab Method
Rinse Water Method
ATP Bioluminescence Method
Frequency of Microbial Monitoring of Sanitized Equipment
Microbial Test Specifications for Sanitized Equipment
Summary
References
10 Hazard Analysis and Critical Control Point (HACCP) Protocols in Cosmetic Microbiology
Introduction
Why Apply HACCP to Cosmetics?
Wastewater Removal and CIP Systems
Selecting Critical Control Points
Parameters of an Effective HACCP Program
Losses Preventable via an Effective HACCP Program
Tri-Blender Operation
Retention of Diluted Product in Low-Point Strainer
Susceptible Premix Operation
Inoculating CIP System and Multiple Processing Flow Paths
Conclusion
References
11 Manufacturing Microbiology
A View of the Future
Introduction
The Changing Business Demands/Business Model—Speed
Microbiological Quality by Design
Test Faster—The Use of Rapid Microbiological Test Methods
Innovations and New Concepts
Control Factors for Real-Time Release (RTR)
References
12 Consumer Safety Considerations of Cosmetic Preservation*
Introduction
Use of Existing Information
Trade Associations
Regulatory Considerations
External and Technical Considerations
Consumer Safety Considerations for Preservatives
Fundamentals of Toxicology
Hazard Identification
Dose–Response Assessment
Exposure Considerations
Risk Characterization
Toxicity Studies Grouped by Exposure Duration
Acute Toxicity Studies
Subacute and Subchronic Toxicity Studies
Chronic Toxicity Studies
Toxicity Studies Grouped by Toxic Endpoint
Ocular Irritation Tests
Introduction to Skin
Skin Responses to Preservatives
Irritant Responses
Skin Sensitization
Provocative Use Testing for Sensitization
Genotoxicity and Carcinogenicity Testing
Reproductive and Developmental Toxicity Testing
Post-Marketing Surveillance
Conclusion
References
13 Global Regulation of Preservatives and Cosmetic Preservatives
Introduction
United States Regulations
Regulation of Preservatives
Regulation of Biocides
Regulation of Antimicrobial Ingredients
Efficacy Tests
Safety Tests
Topical Acne Drugs
Antifungal Drugs (see Table 13.4)
Dandruff, Seborrheic Dermatitis, and Psoriasis Drugs (see Table 13.5)
Regulation of Cosmetic Microbiology
European Union Regulations
Annex V–Approved Preservatives
Requirements for Annex V Submissions
Prohibited Preservatives
Japan Regulations
Approved Preservatives for Cosmetics
Requirements for New Preservatives
Prohibited Preservatives
Non-Regulatory Considerations
Non-Preservative Preservatives
Concluding Comments
References
Index