Disinfection and Decontamination

A Practical Handbook

Jeanne Moldenhauer

• Publisher: CRC Press
• Year: 2018
• ISBN:
  9781351217002
• Edition: 1
• Topic: Medicine
• Subtopic: Biotechnology in Medicine

This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

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• Explores new technologies that may be useful in the battle for decontamination

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• Examines various methods of decontamination and how the methods work

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• Addresses contamination issues for a variety of manufacturing processes and industries

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• Describes how to detect contaminants as well as how to deal with contaminants that are present

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• Includes methods for both decontamination (reaction) and preventing contamination (proactive)

1	Introduction

Jeanne Moldenhauer

CONTENTS

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

1.1 Background

Most regulated industries have experienced problems with contamination. Contamination comes in many forms, e.g., microbial, viral, endotoxin, chemical, or particulate. This book is focused on many topics that describe types of microbial and viral contamination and how they may be addressed using disinfection procedures, sanitization procedures, sterilization procedures, and a variety of new technologies. There are even some technologies that can prevent contamination from specific types of organisms for specified periods of time.

While the types and levels of contamination may be different in foods, devices, drugs, and biologics, many of the ways to deal with the contamination are the same. Many of the issues in using these disinfection and decontamination processes are the same for each different type of product.

This book describes a variety of different ways to perform disinfection, how to qualify disinfectants and preservatives, new technologies for decontamination or sterilization, and sterilization methods. All of the chapters will provide guidance for the development of your contamination control program at your facility.

1.2 Regulatory Issues with Disinfection and Decontamination

In recent years, there have been many significant issues with contamination across the regulated industries. Some of the predominant cases are described below.

1.2.1 The New England Compounding Center (NECC)

There was a major meningitis outbreak that was attributed to the New England Compounding Center (NECC) in Massachusetts in 2012. There were reports of over 800 individuals sickened with meningitis and 76 deaths. This outbreak of meningitis affected multiple states and it was investigated by the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the state and local health departments. As a result, it was determined that the outbreak was linked to a contaminated steroid injection produced by NECC. This product was manufactured by NECC, which is designated as a compounding pharmacy. This company is only authorized to create specific formulations of drugs to meet the needs of individual patients and in response to individual prescriptions (Moldenhauer, 2017).

As a result of this outbreak, many different laws and requirements changed. Additionally, legal actions were taken against employees of NECC (Moldenhauer, 2017).

1.2.2 Food Recalls

There were numerous food recalls, and a few of them are listed here.

1.2.2.1 Fieldbrook Foods Corporation Announces a Voluntary Recall of Orange Cream Bars for Possible Health Risk (2018)

Fieldbrook Foods Corporation of Dunkirk, New York, issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. Pregnant women, the very young, elderly, and persons with compromised immune systems are the most susceptible. (FDA, 2018a).

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)

Hong Lee Trading Inc., New York, recalled its Chao Café Vietnamese Instant Coffee Mixed 3 In 1, 384 g containers coded June 6, 2018 due to it containing undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product (FDA, 2018a).

1.2.2.3 Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk (2018)

Evershing International Trading Company recalled its 16 ounce Coconut Tree Brand Frozen Shredded Coconut product because it had the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. No illnesses have been reported to date (FDA, 2018a).

1.2.2.4 T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed under Various Brands Due to Potential Listeria Contamination (2018)

T. Marzetti Company recalled “Best By” dates of various products that were distributed in Alabama, Florida, Georgia, Indiana...

Table of contents

• Cover
• Half-Title
• Title
• Copyright
• Contents
• Editor
• Contributors
• Chapter 1 Introduction
• Chapter 2 Disinfectants and Biocides
• Chapter 3 Disinfecting Agents
• Chapter 4 The Microbiome and Its Usefulness to Decontamination/Disinfection Practices
• Chapter 5 Disinfectant Qualification Testing Considerations for Critical Manufacturing Environments
• Chapter 6 Methods for Contamination Detection
• Chapter 7 Residue Removal in Cleanroom Environments
• Chapter 8 Microbiological Concerns in Non-Sterile Manufacturing
• Chapter 9 Preservatives and Why They Are Useful
• Chapter 10 The Problem of Burkholderia cepacia Complex (BCC) in Your Facility
• Chapter 11 What Is Mold and Why Is It Important?
• Chapter 12 Sterilization Methods
• Index