Disinfection and decontamination : a practical handbook

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Cover Half Title Title Page Copyright Page Contents Editor Contributors 1: Introduction Jeanne Moldenhauer 1.1 Background 1.2 Regulatory Issues with Disinfection and Decontamination 1.2.1 The New England Compounding Center (NECC) 1.2.2 Food Recalls 1.2.2.1 Fieldbrook Foods Corporation Announces a Voluntary Recall of Orange Cream Bars for Possible Health Risk (2018) 1.2.2.2 Hong Lee Trading Inc. Issues Allergen Alert on Undeclared Milk Allergens in Chao Café Vietnamese Instant Coffee Mixed 3 in 1 (2018) 1.2.2.3 Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk (2018) 1.2.2.4 T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed under Various Brands Due to Potential Listeria Contamination (2018) 1.2.2.5 Nodine’s Smokehouse Inc. Recalls Smoked Salmon 1.5 lb, 8 oz Packages Due to Possible Listeria monocytogenes Contamination (2017) 1.2.2.6 Fresh Pak Inc. Recalls Lot-Specific Sliced Apple Products Because of Possible Health Risk (2017) 1.2.2.7 Piller’s Fine Foods Recalls Ready-to-Eat Salami and Speck Products Due to Possible Salmonella Adulteration (2017) 1.2.3 Recent Drug Recalls 1.2.3.1 Compounded Injectables 1.2.3.2 Linezolid Injection 1.2.3.3 Pantoprazole Sodium Injection 1.2.3.4 Alcohol Prep Pads 1.2.3.5 Riomet® (MetFormin Hydrochloride Oral Solution) 1.2.3.6 Amiodarone HCl 1.2.4 Comments 1.3 Why This Book Is Important 1.4 Conclusion Literature Cited 2: Disinfectants and Biocides Tim Sandle 2.1 Introduction 2.2 Terms and Definitions 2.3 Killing, Inactivating, and Inhibiting Microorganisms 2.4 The Importance of Pre-Cleaning 2.5 Types of Disinfectants 2.5.1 Common Non-Sporicidal Disinfectants 2.5.2 Alcohols 2.5.3 Aldehydes 2.5.4 Amphoterics 2.5.5 Acid Anionics 2.5.6 Biguanides 2.5.7 Phenolics 2.5.8 Quaternary Ammonium Compounds (QACs) 2.5.9 Sporicidal Agents 2.5.9.1 Examples of Sporicides 2.5.10 Hand Sanitization 2.6 What Determines Disinfection Success? 2.7 Selection Criteria 2.8 Disinfectant Formats 2.8.1 Concentrates 2.8.2 Spray Bottles 2.8.3 Wipes 2.9 Disinfectant Rotation 2.10 Application of Disinfectants 2.10.1 Cleaning and Disinfection Schedules 2.10.2 Mops and Wipes 2.10.3 Double or Triple Bucket System Two-Bucket Technique Three-Bucket Technique 2.10.4 Cleaning and Disinfection Techniques 2.10.5 Rinsing Disinfectant Residues 2.10.6 Disposal of Agents 2.10.7 Sterile Disinfectants 2.10.8 Hand Sanitizers and Antiseptics 2.10.9 Other Good Practices 2.11 Disinfectant Efficacy Testing 2.11.1 Approaching Disinfectant Validation 2.11.2 Suspension or Surface Testing? 2.11.3 Selection of the Microbial Test Panel and Assessing Microbial Kill 2.11.4 The Validation Approach 2.11.5 Additional Testing 2.11.6 Revalidation 2.11.7 Regulatory Concerns 2.12 Environmental Monitoring 2.13 Alternatives to Disinfectant Practices 2.14 Cleaning Validation 2.15 Conclusion References 3: Disinfecting Agents: The Art of Disinfection Arthur Vellutato, Jr. 3.1 Introduction 3.2 Disinfection Process at a Glance 3.3 Terminology—Sanitizers, Disinfectants, Sporicides, and Sterilants 3.3.1 Sanitizer 3.3.2 Disinfectant 3.3.3 Specific Sporicidal Product 3.3.4 Sporicide/Cold Sterilant 3.4 Contamination Control 3.5 Cleaning versus Disinfection 3.6 Worldwide Regulatory Requirements for Agents and Good Manufacturing Practice (GMP) 3.7 Antimicrobial Effectiveness 3.8 Assay of Disinfecting Agents 3.9 Sterility of Disinfecting Agents 3.10 Available Sanitizers, Disinfectants, and Sporicides for GMP Operation 3.10.1 Isopropyl Alcohol, Ethyl Alcohol, Ethanol Solutions 3.10.2 Phenols 3.10.3 Quaternary Ammonium Compounds 3.10.4 Sodium Hypochlorite 3.10.5 Hydrogen Peroxide 3.10.6 Peracetic Acid and Hydrogen Peroxide 3.10.7 Glutaraldehyde 3.10.8 Formaldehyde 3.11 Antimicrobial Effectiveness Testing Conducted on GMP Environmental Isolates and ATCC Cultures at VAI Laboratories 3.12 Resistance Theories to Germicidal Agents 3.13 Conclusion 3.14 Special Acknowledgment BIBLIOGRAPHY 4: The Microbiome and Its Usefulness to Decontamination/Disinfection Practices Jeanne Moldenhauer 4.1 What is the Human Microbiome? 4.2 Introduction – The Human Microbiome Project (HMP) 4.3 Testing and Results of the Human Microbiome Project 4.3.1 Work Completed for the Human Microbiome Project 4.4 Applications of the Human Microbiome Project to Regulated Industries 4.4.1 Applicable Regulatory Requirements 4.4.2 Uses of the Human Microbiome Project for Decontamination and Disinfection Procedures Literature Cited 5: Disinfectant Qualification Testing Considerations for Critical Manufacturing Environments Dave Rottjakob and Christine Chan 5.1 INTRODUCTION 5.2 THE IMPORTANCE OF DISINFECTION QUALIFICATION STUDIES 5.2.1 Control of Microbiological Contamination 5.2.2 Disinfection Efficacy 5.2.3 Excerpts from FDA Form 483 Warning Letters 5.3 Difference Between Disinfection Qualification and Validation 5.3.1 Disinfection Qualification 5.3.2 Disinfection Validation 5.3.3 Cleaning Validation 5.4 The FDA Requires Disinfection Qualification Studies 5.4.1 When to Conduct Disinfection Qualification Studies 5.5 Deciding How to Perform Disinfection Qualification Studies 5.5.1 Suspension-Based Testing versus Coupon-Based Testing 5.5.2 Scope of Qualification Testing 5.6 Overview of Study Design 5.7 Conclusion 5.8 About the Authors References 6: Methods for Contamination Detection Jeanne Moldenhauer 6.1 Introduction 6.2 A Complete Environmental Monitoring Program – What Does It Encompass? 6.3 Are There Gaps in Your Program? 6.4 The Environmental Monitoring Committee 6.4.1 Types of Documents Reviewed by the Committee 6.4.2 Managing the Environmental Monitoring Committee 6.4.3 What Type of Outputs Should Come from the Environmental Monitoring Committee? 6.4.4 Responsibility of the Committee 6.5 The Microbiological Master Plan 6.6 Risk Assessments to Determine the Sampling Locations 6.6.1 How Many Sample Sites Should Be Selected? 6.6.1.1 Non-Viable Particulates 6.6.1.2 Viable Active Air Sampling 6.6.1.3 Passive Air Sampling (Settle Plates) 6.6.1.4 Surface Samples 6.6.2 Where Should I Sample? 6.7 Developing Test Methods 6.8 Selecting the Appropriate Incubation Conditions and Media 6.8.1 Historical Approaches 6.8.2 A Protocol to Justify Incubation Conditions Used 6.8.2.1 Phase One – Laboratory Testing 6.8.2.2 Phase Two – Comparative study 6.9 Setting Action and Alert Levels 6.10 Determining the Objectionable Organisms 6.11 Qualifying Your Environmental Monitoring Program 6.12 Selecting Routine Sampling Locations 6.13 Establishing a Library of Environmental Isolates 6.14 Handling Microbial Data Deviations 6.15 Conducting Product Impact Assessments 6.16 Documentation 6.17 Environmental Monitoring Is a Living System 6.18 Conclusion Acknowledgments Literature Cited 7: Residue Removal in Cleanroom Environments Jim Polarine and Beth Kroeger 7.1 Background 7.2 Regulatory Expectations and Guidance 7.3 Why Residue is a Major Concern 7.4 Drains in Cleanrooms and Controlled Areas 7.5 Residue Sources 7.6 Case Study: Removal of Residue from Drug Product Interaction with Disinfectant Solution 7.7 Recommended Procedure for Residue Removal 7.8 Residue Remediation – An In Situ Case Study 7.9 Best Practices 7.10 Conclusion References 8: Microbiological Concerns in Non-Sterile Manufacturing Jim Polarine, Jr. and Joe McCall 8.1 Introduction 8.1.1 The Special Case of Non-Sterile Manufacturers 8.1.2 What Is Sound Science? 8.2 Origins of Microbial Contaminants 8.3 Evaluating the Possible Effects of Microbial Content 8.4 Microbial Growth and Characteristics 8.5 Detection Methods and Capabilities 8.6 Evaluating Recovered Organisms 8.7 How to Perform a Risk Assessment Using Compendial Guidance 8.8 The Use of the Product: Hazard Varies According to the Route of Administration (Eye, Nose, Respiratory Tract) 8.9 The Method of Application 8.10 The Intended Recipient: Risk May Differ for Neonates, Infants, and the Debilitated 8.11 Use of Immunosuppressive Agents, Corticosteroids 8.12 Presence of Disease, Wounds, Organ Damage 8.13 Microbiological Control 8.14 People 8.15 Raw Materials and Other Components 8.16 Equipment 8.17 Environment References 9: Preservatives and Why They Are Useful Jeanne Moldenhauer 9.1 Introduction 9.2 What Is a Preservative? 9.3 Classification of Preservatives 9.3.1 Classification of Preservatives Based upon the Mode of Action 9.3.1.1 Antioxidants 9.3.1.2 Antimicrobial Agents 9.3.1.3 Chelating Agents 9.3.2 Classification of Preservatives Based Upon the Preservative Source 9.3.2.1 Natural Preservatives 9.3.2.2 Artificial Preservatives 9.4 Choosing the Right Preservative 9.4.1 Common Preservatives and Route of Administration 9.4.2 Oral Suspensions and Issues with Preservative Effectiveness 9.4.2.1 Formulation pH 9.4.2.2 Micelles 9.4.2.3 Hydrophilic Polymers 9.4.2.4 Use of Plastic Containers 9.4.2.5 Factors That Can Result in Loss of Preservative Action 9.4.3 Preservative Modes of Action 9.4.3.1 Preservatives Affecting the Cell Wall 9.4.3.2 Preservatives Affecting the Cytoplasmic Membrane 9.4.3.3 Preservatives Affecting the Cytoplasm 9.5 Regulatory Expectations for Use of Preservatives 9.5.1 Performance Expectations for Preservatives 9.5.2 Preservative Effectiveness Testing (PET) AKA AntiMicrobial Effectiveness Testing (AET) 9.6 Products without Preservatives 9.7 Typical Considerations/Concerns with Use of Preservatives 9.7.1 Is the Addition of a Known Preservative Sufficient to Control Contamination? 9.7.2 Is Packaging a Concern with Preservative Use? 9.7.3 Does the Storage Conditions Affect Preservatives? 9.8 Conclusion Literature Cited 10: The Problem of Burkholderia cepacia Complex (BCC) in Your Facility Jeanne Moldenhauer 10.1 What is BCC? 10.2 Regulatory Requirements for BCC Testing 10.2.1 History of Regulatory Recalls Due to BCC 10.2.2 What Is Expected of Drug Manufacturers 10.3 Controlling the Microbiological Quality of Your Products 10.3.1 Understanding the Risk to the Patient 10.3.1.1 Route of Administration 10.3.1.2 Patient Population 10.3.1.3 Dosage Form/Product Formulation 10.4 Sources of Microorganisms in Pharmaceutical Manufacturing 10.4.1 Raw Materials 10.4.2 Manufacturing Process 10.4.3 Manufacturing Environment 10.5 Microbiological Control Mechanisms 10.5.1 Aqueous and Multi-Dose Products 10.5.2 Burkholderia cepacia Complex (BCC) 10.6 Case Studies with BCC 10.6.1 Oral Mouthwash Products 10.6.1.1 Background on the Organism Cupriavidus pauculus 10.6.1.2 Health Risks Associated with Cuprividus pauculus (Ralstonia paucula and Wautersia paucula) 10.6.1.3 Conclusion of the Investigation 10.6.2 Aqueous Non-Sterile Products 10.6.2.1 Health Concerns with This Organism 10.6.2.2 Changes to Manufacturing Practices during the Investigation 10.6.2.3 Results of Ozonated Water for Decontamination 10.7 Conclusion Literature Cited 11: What Is Mold and Why Is It Important? Brian G. Hubka and Jeanne Moldenhauer 11.1 Defining Mold 11.2 Why Are Molds Important? 11.2.1 Pathogenicity 11.2.2 Mycotoxin Production 11.2.3 Allergic Reactions 11.2.4 Invasiveness of Mold 11.3 Criteria for Mold Growth 11.3.1 Product Impact Analysis 11.4 Mold Detection and Identification 11.4.1 Mold Detection 11.4.2 Selective Media 11.4.3 Incubation Conditions 11.4.4 Mold Identification 11.5 Setting Limits for Mold Contamination 11.5.1 Aseptic Processes 11.5.2 Non-Sterile Processes 11.5.3 World Health Organization (WHO) 11.6 Mold Remediation Methods 11.6.1 Contaminated Building Facilities 11.6.2 Contaminated Equipment and/or Surfaces 11.6.3 Contaminated Product 11.7 Mold Prevention Methods Case Study on Mold (Falco 2017): 11.8 Conclusion Literature Cited 12: Sterilization Methods Jeanne Moldenhauer 12.1 Microbiological Control Strategies in the Manufacture of Regulated Products 12.2 Defining Sterilization 12.3 What is the Difference Between Sterilization and Sanitization? 12.4 Key Concepts for the Validation of Sterilization Processes 12.5 What Regulatory Requirements Must be Met for Sterilization Validation? 12.6 Types of Sterilization Processes 12.6.1 Sterilizing Filtration Frequently Misnamed as Aseptic Processing 12.6.2 Chemical Sterilization Methods – Also Known as Liquid Phase Sterilization 12.6.3 Gas Sterilization 12.6.3.1 Ethylene Oxide (EtO) 12.6.3.2 Ozone 12.6.3.3 Nitrogen Dioxide (NO2) 12.6.3.4 Chlorine Dioxide 12.6.3.5 Validating Gas Sterilization Processes 12.6.3.6 Vapor Sterilization 12.6.3.7 Radiation Sterilization 12.6.3.8 Gamma Sterilization 12.6.3.9 Moist Heat Sterilization 12.6.4 Dry Heat Sterilization 12.6.4.1 Dry Heat Ovens 12.6.4.2 Worst Case Conditions 12.6.4.3 Load Size and Configuration 12.6.4.4 Monitoring of Cycles 12.6.4.5 Dry Heat Depyrogenation (and Sterilization) Tunnels 12.6.4.6 Loading 12.6.4.7 Worst Case Challenges 12.6.4.8 Validating Dry Heat Sterilization Processes 12.7 Systems to Maintain Sterilizer Qualification 12.7.1 Personnel Training 12.7.1.1 Summary Report 12.7.1.2 Ongoing Activities 12.8 Conclusion References Index