Radiation Sterilization for Health Care

Focusing on how the radiation process works and how it is applied for sterilization of medical devices and healthcare products, this book provides the latest developments in radiation technology for product sterilization in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency offering the reader practical insights into current uses and cost concerns for this critical step in healthcare product manufacturing. Radiation Sterilization for Health Care Products discusses all the elements of the use of radiation for sterilization.

Foreword

ix

Preface

xi

Historical Perspective

1

(8)

Processes

1

(1)

Sources

2

(2)

Facilities

4

(1)

Regulations

5

(1)

Absorbed Dose

6

(1)

Process Controls

7

(2)

Basic Principles

9

(12)

Gamma Rays

9

(1)

Sources of Gamma Rays

9

(1)

Fabrication of Sources

10

(2)

Interaction of Gamma Rays with Matter

12

(2)

Electrons

14

(1)

Sources of Electrons

15

(1)

Interaction of Electrons with Matter

15

(2)

Sources of X-Rays

17

(4)

Dosimetry

21

(8)

Types of Dosimetry Systems

21

(3)

Calibration of Dosimetry Systems

24

(1)

Selection and Use of Routine Dosimetry Systems

25

(2)

Uncertainty in the Measurement Process

27

(1)

Estimate of Overall Uncertainty

27

(1)

Use of Uncertainty

28

(1)

Effects of Radiation

29

(14)

Materials

29

(7)

Inactivation of Microorganisms

36

(7)

Gamma Irradiators

43

(14)

Classifications and Regulatory Aspects

43

(1)

Different Types of Irradiators

44

(6)

Engineering and Operational Aspects of Gamma Irradiators

50

(7)

Electron Beam Irradiators

57

(16)

Regulatory Aspects

57

(1)

Different Types of Accelerators

58

(11)

Engineering-Operational Aspects of Electron Beam Irradiators

69

(4)

X-Ray Irradiators

73

(10)

Regulatory Aspects

73

(1)

Different Types of X-Ray Irradiators

73

(2)

Engineering-Operational Aspects of X-Ray Irradiators

75

(8)

Sterilization Process Validation

83

(16)

Qualification of an Irradiator

83

(3)

Product Qualification

86

(10)

Process Qualification

96

(1)

Maintenance Program

97

(1)

Documentation

97

(2)

Processing with Irradiators

99

(8)

Tracking

100

(1)

Scheduling

100

(2)

Process Control and Monitoring

102

(1)

Release Mechanisms

103

(2)

Documentation

105

(2)

Commercial Aspects

107

(20)

Costs

107

(2)

Summary of Capital Costs

109

(4)

Summary of Recurring Costs

113

(1)

Operational Considerations

114

(13)

Conclusion

127

(6)

References

133

(6)

Index

139

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

FREE SHIPPING

Amazon no longer offers textbook rentals. We do!

Radiation Sterilization for Health Care Products: X-Ray, Gamma, and Electron Beam

Summary

Table of Contents

Supplemental Materials