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Handbook of Aseptic
Processing and Packaging
SECOND EDITION
Handbook of Aseptic
Processing and Packaging
SECOND EDITION

Jairus R.D. David


Ralph H. Graves
Thomas Szemplenski

Boca Raton London New York

CRC Press is an imprint of the


Taylor & Francis Group, an informa business
CRC Press
Taylor & Francis Group
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© 2013 by Taylor & Francis Group, LLC


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Version Date: 20121003

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Dedication
In memory of
V.R. (Bob) Carlson
Dr. Walter Dunkley
Robert Graves
David R. Dass, Priscilla Juliet Dass, and Rufus David
Lynn Joel Zylstra
Contents
Foreword......................................................................................................... xvii
Preface................................................................................................................xix
Acknowledgments...........................................................................................xxi
Authors........................................................................................................... xxiii
Contributing Authors.................................................................................. xxvii

Chapter 1 Aseptic processing and packaging:


Past, present, and future............................................................. 1
Jairus R.D. David
1.1 Framework and current state.................................................................. 1
1.2 Departures from optima and challenges.............................................. 3
1.3 Current and future opportunities for optimization............................ 4
References............................................................................................................ 8

Chapter 2 United States history and evolution........................................ 9


Ralph H. Graves
2.1 Early pioneers............................................................................................ 9
2.2 The Graves era......................................................................................... 11
2.3 Jack Stambaugh....................................................................................... 12
2.4 The first commercial aseptic plant....................................................... 13
2.5 The real fresh company......................................................................... 13
2.6 The first aseptic form–fill–seal packages............................................ 13
2.7 Early aseptic packers.............................................................................. 14
2.8 Restrictions for growth.......................................................................... 15
2.9 Trends for the future.............................................................................. 16
References.......................................................................................................... 17

Chapter 3 The U.S. markets for aseptic packaging................................ 19


Thomas Szemplenski
3.1 Development........................................................................................... 19
3.2 Aseptic metal can market...................................................................... 20
3.3 Aseptic bag-in-box.................................................................................. 21
3.4 Aseptic paperboard market.................................................................. 25

vii
viii Contents

3.5 Aseptic plastic cup market.................................................................... 28


3.6 Aseptic pouch market............................................................................ 29
3.7 Aseptic plastic bottle market................................................................ 31

Chapter 4 Aseptic processing equipment and systems........................ 33


Thomas Szemplenski
4.1 Introduction............................................................................................. 33
4.2 Aseptic processing equipment............................................................. 34
4.2.1 Basic requirements of aseptic processing equipment......... 34
4.2.2 Blending vessel, balance surge, formulation of product..... 35
4.2.3 Timing pump............................................................................ 36
4.2.3.1 Pumping of foods containing particulates.......... 37
4.2.4 Heat exchangers........................................................................ 39
4.2.4.1 Heating: Sterilization of the products................... 39
4.2.4.2 Steam injection or infusion heaters....................... 39
4.2.4.3 Plate heat exchangers.............................................. 41
4.2.4.4 Tubular heat exchangers......................................... 42
4.2.4.5 Regeneration............................................................. 44
4.2.4.6 Scraped surface heat exchangers........................... 47
4.2.4.7 Ohmic heating.......................................................... 48
4.2.4.8 Microwave heating.................................................. 49
4.2.5 Continuous holding tubes....................................................... 51
4.2.6 Deaerator.................................................................................... 51
4.2.7 Controls...................................................................................... 52
4.2.8 Aseptic surge tanks, barrier seals, and automatic air-
operated valves......................................................................... 54
4.2.8.1 Aseptic surge tanks................................................. 54
4.2.8.2 Barrier seals.............................................................. 55
4.2.8.3 Valves......................................................................... 55
4.2.9 Homogenizers........................................................................... 57
4.2.10 Ingredients................................................................................. 58
4.2.11 Clean-in-place (CIP).................................................................. 59
4.2.11.1 Clean-in-place solutions.......................................... 59
4.3 Plant layout considerations................................................................... 61
4.3.1 Preparation and processing equipment and systems......... 61
4.3.2 Packaging system area (bacteriological conditions)............ 61
4.4 Utilities..................................................................................................... 63
4.4.1 System sterilization water....................................................... 63
4.4.2 Preparation water..................................................................... 64
4.4.3 Heating/cooling water............................................................. 65
4.4.4 Refrigerated water.................................................................... 66
4.4.5 Steam.......................................................................................... 67
4.4.6 Air............................................................................................... 68
Contents ix

4.5 Filters........................................................................................................ 69
4.5.1 Gases........................................................................................... 69
4.5.2 Liquids........................................................................................ 71
4.5.3 HEPA filters............................................................................... 71
4.5.4 General information on filtration........................................... 72
4.6 Chemicals used as sterilizing agents (equipment)............................ 72
4.6.1 Chlorine and iodine................................................................. 73
4.6.2 Oxonia........................................................................................ 74
4.6.3 Food acids.................................................................................. 74
4.6.4 Ozone.......................................................................................... 75
4.6.5 Hydrogen peroxide................................................................... 75
4.6.6 Ultraviolet.................................................................................. 75
References.......................................................................................................... 76

Chapter 5 Aseptic filling and packaging equipment............................ 77


Thomas Szemplenski
5.1 Development of aseptic packaging...................................................... 77
5.2 Dole aseptic canning system................................................................. 79
5.2.1 Can sterilizing unit.................................................................. 79
5.2.2 The filling section..................................................................... 80
5.2.3 Lid sterilizer.............................................................................. 80
5.2.4 The sealer................................................................................... 81
5.3 Aseptic bag-in-box.................................................................................. 81
5.4 Aseptic paperboard fillers..................................................................... 85
5.4.1 Tetra Pak..................................................................................... 85
5.4.2 SIG Combibloc........................................................................... 88
5.5 Aseptic plastic cups................................................................................ 88
5.5.1 Bosch and Erca.......................................................................... 88
5.5.2 OYSTAR Hassia, Erca, Gasti, and Hamba............................. 89
5.5.3 Ampack Ammann, Benco, and Metal Box............................ 89
5.6 Coffee creamers...................................................................................... 91
5.7 Aseptic pouches...................................................................................... 91
5.7.1 Bosch........................................................................................... 92
5.7.2 DuPont/Liqui-Box and Inpaco............................................... 92
5.7.3 Fres-co........................................................................................ 93
5.7.4 OYSTAR Hassia......................................................................... 93
5.7.5 Cryovac...................................................................................... 93
5.8 Aseptic plastic bottle fillers................................................................... 94
5.8.1 Ampack Ammann.................................................................... 95
5.8.2 Bosch........................................................................................... 95
5.8.3 Krones........................................................................................ 95
5.8.4 OYSTAR Hamba....................................................................... 95
5.8.5 Procomac.................................................................................... 97
5.8.6 Serac............................................................................................ 98
x Contents

5.8.7 Shibuya Kogyo.......................................................................... 99


5.8.8 Sidel/Tetra Laval....................................................................... 99
5.9 Stork........................................................................................................ 101

Chapter 6 Aseptic packaging materials and sterilants....................... 103


Robert Fox
6.1 Product requirements.......................................................................... 103
6.2 Materials................................................................................................ 103
6.2.1 Nonbarrier sheeting............................................................... 105
6.2.2 Barrier sheeting....................................................................... 105
6.3 Sterilizing Agents................................................................................. 105
6.3.1 Heat........................................................................................... 106
6.3.2 Hot water................................................................................. 106
6.3.3 Neutral aseptic system (NAS)............................................... 106
6.3.4 Chemical sterilants................................................................. 109
6.3.5 Radiation.................................................................................. 109
6.4 Packaging systems.................................................................................110
6.4.1 Dole aseptic canning...............................................................110
6.4.2 Preformed thermoformed containers...................................110
6.4.3 Form–fill–seal (FFS).................................................................110
6.5 Environmental considerations.............................................................115

Chapter 7 Aseptic bulk packaging.......................................................... 119


Thomas Szemplenski
7.1 Aseptic bag-in-box.................................................................................119
7.2 Aseptic bulk container......................................................................... 121
7.3 Aseptic bulk storage............................................................................. 122
7.4 Aseptic ocean liner transportation and storage............................... 125

Chapter 8 Regulations for aseptic processing and


packaging of food.................................................................... 129
Ralph H. Graves
8.1 U.S. Food and Drug Administration requirements
and approval..................................................................................... 129
8.1.1 European versus U.S. approach............................................ 129
8.1.2 U.S. Food and Drug Administration
and U.S. Department of Agriculture................................... 129
8.1.3 Pasteurized milk ordinance.................................................. 130
8.1.4 State regulations..................................................................... 130
8.1.5 Hazard analysis critical control point approach................ 130
8.2 Code of Federal Regulations (CFR).................................................... 131
8.3 Low-acid food regulations and definitions...................................... 131
8.4 U.S. Food and Drug Administration: Specific concerns................. 133
Contents xi

8.5 Other requirements.............................................................................. 135


References........................................................................................................ 137

Chapter 9 Validation and establishment of aseptic processing


and packaging operations...................................................... 139
Jairus R.D. David and V.R. (Bob) Carlson
9.1 Some considerations............................................................................. 139
9.2 Decision process................................................................................... 140
9.3 Equipment selection............................................................................. 140
9.4 Process schematic and process and instrument
diagrams (P&IDs)..................................................................................141
9.4.1 Process schematic....................................................................141
9.4.2 P&ID schematic........................................................................141
9.5 Preinstallation review.......................................................................... 142
9.5.1 Sterilization, operation, clean-in-place,
and maintenance................................................................... 143
9.5.2 Interlocks.................................................................................. 144
9.5.3 Hold tube................................................................................. 144
9.5.4 Timing pump.......................................................................... 145
9.5.5 Controls.................................................................................... 145
9.6 Postinstallation review........................................................................ 146
9.7 Equipment testing and validation...................................................... 146
9.7.1 Aseptic processing system.................................................... 147
9.7.2 Aseptic surge tank.................................................................. 148
9.7.3 Aseptic packaging system..................................................... 150
9.7.3.1 Filler and filler bowl sterilization tests and
sterile gas lines and fiber sterilization tests....... 150
9.7.3.2 Aseptic zone sterilization tests............................ 151
9.7.3.3 Container and lid sterilization tests.................... 152
9.7.3.4 Conveyor chain sterilization tests....................... 152
9.8 Thermal process design for products containing particles
(principles applicable to homogenous fluid foods).......................... 153
9.8.1 Scraped surface heat exchangers with straight
hold tubes................................................................................ 153
9.8.2 Microbiological validation.................................................... 154
9.8.2.1 Microbiological aspects......................................... 154
9.8.2.2 Quality and optimization considerations.......... 155
9.8.3 Process filing........................................................................... 155
9.9 Factors other than temperature contributing to nonsterility......... 156
9.10 Summary............................................................................................... 157
Acknowledgments.......................................................................................... 158
References........................................................................................................ 158
xii Contents

Chapter 10 Aseptic processing operations.............................................. 161


Thomas Szemplenski
10.1 Introduction............................................................................................161
10.2 Presterilization of the processing system..........................................162
10.3 Loss of sterility...................................................................................... 163
10.4 Water-to-product separation............................................................... 163
10.5 Product-to-water separation................................................................ 164
10.6 Cleaning................................................................................................. 165
10.7 Control.................................................................................................... 165

Chapter 11 Thermal processing and optimization................................ 167


Jairus R.D. David
11.1 Thermal processing and optimization...............................................167
11.1.1 Introduction..............................................................................167
11.1.2 Principles of thermal process calculations..........................167
11.1.3 Thermal process design and commercial sterility............ 170
11.1.4 Economic spoilage.................................................................. 170
11.1.5 Thermal destruction of enzymes, nutrients, and
quality factors.......................................................................... 171
11.1.6 Optimization of thermal processes for nutrients and
quality retention..................................................................... 172
11.1.6.1 Agitated retort........................................................ 172
11.1.6.2 The “Flash 18” process.......................................... 172
11.1.6.3 Ultra-high temperature (UHT) processing
and aseptic packaging........................................... 173
11.2 Comparison of conventional canning and aseptic processing
and packaging of foods........................................................................174
11.2.1 ................................................................................................
Comparison of conventional canning and aseptic
processing and packaging of foods......................................174
11.2.2 Some advantages of aseptic processing and
packaging of foods................................................................. 175
11.2.2.1 Nutritional quality................................................. 175
11.2.2.2 Sensory quality...................................................... 175
11.2.2.3 Microwaveability................................................... 175
11.3 Comparison of processing methods.................................................. 178
11.3.1 Pasteurization.......................................................................... 178
11.3.2 Ultra-pasteurization............................................................... 179
11.3.3 Conventional canning............................................................ 179
11.3.4 Refrigerated aseptic products............................................... 180
11.3.5 Comparison of continuous processing methods based
on optimization hierarchy..................................................... 180
Contents xiii

11.4 Definitions............................................................................................. 183


11.5 Nomenclature........................................................................................ 185
References........................................................................................................ 186

Chapter 12 Quality assurance and food protection for


aseptically processed and packaged food........................... 187
Jairus R.D. David
12.1 Introduction and concepts.................................................................. 187
12.1.1 Quality control........................................................................ 188
12.1.2 Quality assurance................................................................... 188
12.2 Quality assurance for aseptically processed and packaged food..... 188
12.2.1 Preprocess assurance............................................................. 189
12.2.1.1 Raw materials......................................................... 189
12.2.2 In-process assurance.............................................................. 190
12.2.2.1 Batch preparation................................................... 190
12.2.2.2 Thermal processing operations........................... 191
12.2.2.3 Aseptic filling and packaging operations.......... 193
12.2.3 Postprocess assurance............................................................ 196
12.2.3.1 Incubated product evaluation.............................. 197
12.2.3.2 Microbiological testing for sterility and
sample size consideration..................................... 197
12.2.3.3 Distribution, handling, and storage.................... 198
12.2.3.4 ASTM drop test...................................................... 198
12.2.3.5 Cumulative assurance and product release....... 199
12.3 Hazard analysis critical control point (HACCP) program............. 199
12.3.1 Principles of HACCP.............................................................. 199
12.3.2 Categories of hazards............................................................. 200
12.4 Others..................................................................................................... 200
12.4.1 Consumer complaints............................................................ 200
12.4.2 Recalls and spoilage............................................................... 201
References........................................................................................................ 201

Chapter 13 Failure mode and effect analysis, and spoilage


troubleshooting........................................................................ 203
Jairus R.D. David
13.1 Failure mode and effect analysis........................................................ 203
13.2 Failure mode and effect analysis, and troubleshooting.................. 203
13.2.1 Systems analysis and bioburden.......................................... 204
13.2.1.1 Canning or retorting............................................. 204
13.2.1.2 Aseptic processing and packaging..................... 204
13.2.2 Failure modes, analysis of their effects, and controls....... 207
13.2.2.1 Type 1: Incoming raw ingredients, handling,
storage, and batching............................................ 207
xiv Contents

13.2.2.2 Type 2: Equipment preparation and setup......... 208


13.2.2.3 Type 3: Thermal process design and
delivery—Heat cycle.............................................. 209
13.2.2.4 Type 4: Thermal process design and
delivery—Cool cycle............................................. 210
13.2.2.5 Type 5: Incoming packaging material and its
sterilization............................................................. 210
13.2.2.6 Type 6: Aseptic zone integrity and
environmental load................................................211
13.2.2.7 Type 7: Package seal integrity.............................. 213
13.2.3 Cause-and-effect relationships............................................. 213
13.2.3.1 Microbiological and package integrity
testing for troubleshooting................................... 213
13.2.4 Summary..................................................................................214
13.3 Nomenclature........................................................................................ 215
Acknowledgments...........................................................................................216
References.........................................................................................................216

Chapter 14 Aseptic processing of particulate foods.............................. 217


Pablo M. Coronel, Josip Simunovic, and Kenneth R. Swartzel
14.1 Introduction........................................................................................... 217
14.2 Considerations for equipment design............................................... 221
14.2.1 Heat exchangers...................................................................... 221
14.2.2 Novel heating technologies................................................... 223
14.2.3 Transport of liquids with particulates................................. 227
14.3 Validation of aseptic processes with particulates............................ 229
14.3.1 Available technologies and alternatives for validation......233
14.3.2 Practical considerations for validation of continuous
flow sterilization treatments of particulate foods
based on conservatively designed fabricated carrier
particles and residence time and thermosensitive
implants................................................................................... 238
14.3.3 Fabricated carrier particles: Selection, design, and
relevant property adjustments............................................. 238
14.3.4 Achieving conservative thermal characteristics of
carrier particle enclosures..................................................... 240
14.3.5 Experimental confirmation and adjustment of
conservative thermal properties.......................................... 244
14.3.6 Thermal property adjustments for advanced heating
applications.............................................................................. 244
14.3.7 Tags and implants used within the carrier particle
cavities for residence time and time–temperature
history measurements............................................................ 249
Contents xv

14.3.8 Insertion, unobstructed flow, and retrieval of


fabricated tag and implant-carrying particles.................... 254
14.4 Concluding remarks............................................................................. 259
References........................................................................................................ 260

Chapter 15 Industry research and development, and


management needs and challenges...................................... 263
Jairus R.D. David
15.1 Introduction........................................................................................... 263
15.2 Research and development needs and challenges.......................... 265
15.2.1 Raw product............................................................................ 265
15.2.1.1 Raw food quality.................................................... 265
15.2.1.2 Thermization.......................................................... 266
15.2.1.3 Enzyme blockers and biotechnology.................. 266
15.2.1.4 Economic spoilage and control............................ 266
15.2.2 Processing................................................................................ 267
15.2.2.1 12D “Bot Cook” for milk....................................... 267
15.2.2.2 Lethality credit for come-up time....................... 267
15.2.2.3 Control of hold time and temperature................ 268
15.2.2.4 Heat exchangers and product quality................ 269
15.2.2.5 Holding tubes......................................................... 269
15.2.2.6 Cooling cycle and leak detection......................... 271
15.2.2.7 Surge tank............................................................... 271
15.2.2.8 Aseptic processing of low-acid particulate
foods........................................................................ 271
15.2.2.9 Ohmic heating........................................................ 273
15.2.2.10 Microwave heating.................................................274
15.2.2.11 Other nonthermal processes.................................274
15.2.2.12 Additive and synergistic processes......................274
15.2.3 Aseptic filling and packaging................................................274
15.2.3.1 Line speed................................................................274
15.2.3.2 At-line and on-line measurements...................... 275
15.2.3.3 Packaging issues.................................................... 275
15.2.3.4 Bulk packaging....................................................... 276
15.2.3.5 Pulsed light technology........................................ 276
15.2.3.6 Seal integrity........................................................... 277
15.2.3.7 Aseptic filler or sterile work zone integrity
and validation........................................................277
15.2.3.8 Cleanup and extended run................................... 279
15.2.3.9 Defect rate or sterility assurance level (SAL)..... 279
15.2.4 Finished product and package............................................. 281
15.2.4.1 Flavor problems..................................................... 281
15.2.4.2 Gelation and other physical defects.................... 281
xvi Contents

15.2.4.3 Rapid microbiological methods........................... 281


15.2.4.4 Consumer education............................................. 282
15.2.4.5 “Aseptic” versus quality fresh............................. 282
15.2.4.6 Product development............................................ 283
15.3 Management and administrative challenges................................... 283
15.3.1 Capital cost.............................................................................. 283
15.3.2 Complexity.............................................................................. 283
15.3.3 Reliability................................................................................. 284
15.3.4 Repair and maintenance........................................................ 284
15.4 Future..................................................................................................... 285
15.5 Summary............................................................................................... 286
Acknowledgment............................................................................................ 287
References........................................................................................................ 287

Appendices Contract manufacturing for aseptic processing


and packaging......................................................................... 289
Thomas Szemplenski
Appendix A: Aseptic filler profiles.............................................................. 291
Appendix B: Aseptic contract packers in the United States..................... 349
Foreword
This book is a good resource for people who currently aseptically package
and process foods, as well as for people who might wish to get involved
in aseptic packaging and processing of foods. The book is based upon the
extensive experience and knowledge of the authors in the aseptic food
processing and equipment industry. The authors have a wide range of
experience encompassing production, quality assurance, research and
development, and sales in the aseptic packaging and processing indus-
tries. The information provided is very practical and can be used as a
guide to develop or review current day-to-day procedures for a number
of different aseptic processing and packaging applications.
This book is an updated and reorganized version of the previous
book Aseptic Processing and Packaging of Food: A Food Industry Perspective
(CRC Press, 1996). Chapters on aseptic packaging materials and steril-
ants, aseptic bulk packaging, aseptic processing operations, failure mode
effect analysis and spoilage troubleshooting, aseptic processing of par-
ticulate foods, and contract manufacturing have been added. These chap-
ters encompass current information and practical applications so that
those in need have a valuable useful resource. The appendices have a
list of aseptic packaging equipment including those currently accepted
by the U.S. Food and Drug Administration (FDA) and a list of manu-
facturers that do contract packaging. The chapter on aseptic packaging
of particulate foods (Chapter 14) has current information on the use of
microwave to heat particulate foods as well as the most recent technol-
ogy available to monitor and develop processes for this special category
of foods. Chapter 13 on failure mode analysis provides some examples
of failure modes and their effects on food safety. Chapter 10 on asep-
tic processing operations discusses the totality of the operation includ-
ing the processing of the product, including the operation of the aseptic
packaging system. Chapter 7 on aseptic bulk packaging, provides not
only a historical perspective but also an update on the state of bulk pack-
aging in container sizes of several gallons to several millions of gallons
of product. The chapter on aseptic packaging materials and sterilants

xvii
xviii Foreword

(Chapter 6) consolidates information on these subjects into one chapter


and provides up-to-date information.
This book is simple to use and understand with clear chapter head-
ings. The chapters are well organized and follow a logical sequence so
that topics are easy to locate. Once found, the information is understand-
able and can be put to immediate use. The information is current to the
time (2012) it was written and has been provided from the perspective of
individuals with experience in the subject.
The book provides an excellent update on the status of aseptic pro-
cessing and packaging and deserves a space in the library of anyone with
an interest in aseptic processing and packaging of foods.

Keith A. Ito
Laboratory for Research in Food Preservation
Food Science and Technology
University of California, Davis
Preface
This book provides a comprehensive treatment of aseptic processing and
packaging for people interested in the food and beverage processing indus-
try. It is based primarily on the extensive experience of the authors in
processing, marketing, business, quality assurance, and research and devel-
opment related to aseptically processed and packaged foods and beverages.
There have been dynamic changes that have occurred in the food
industry since the publication of our previous book in 1996 (David,
Graves, and Carlson). Our objective was to assemble in one volume the
large amount of information that has been published and to update
changes in food packaging, especially aseptic filling into plastic bottles,
one of the fastest growing areas in the retail sector, and bulk packaging of
value-added commodity products such as juice, concentrate, and puree.
Opportunities for the application of existing and novel food processing
methods and sensor technologies are also discussed in various chapters.
The three coauthors and the contributing authors have more than 150
years of combined food industry experience in aseptic processing and
packaging of foods, which is reflected in the 15 chapters and appendices.
We realize that there may be some duplication and overlap between chap-
ters but we think that readers can read and analyze specific chapters, and
obtain the information desired rather than having to read the entire book.
For many years, researchers recognized that the use of high tempera-
tures for short times had potential advantages over conventional thermal
processes at lower temperatures for longer times, but there were difficul-
ties in taking advantage of this information. Heat causes reactions in food,
some of which are undesirable; the rate of reaction approximately doubles
for every increase in temperature of 10C° (18F°). In contrast, typical rates
of destruction of bacteria and spores increase tenfold for the same temper-
ature increase. Therefore, processes using higher temperatures for shorter
times can achieve commercial sterility with improvements in quality with
respect to flavor, color, vitamin retention, and physical properties, as com-
pared to the quality of products from conventional heat processes.
Application of this principle was limited by the availability of processes
and equipment to apply it in commercial practice. Rapid heat transfer for

xix
xx Preface

heating and cooling is readily achieved in liquid foods but not in solid
foods, which depends on conduction heat transfer rather than convection.
Therefore, early work focused on liquid foods, especially milk and its prod-
ucts. Specialized equipment was developed for applying ultra-high temper-
ature (UHT) treatments using tubular or other heat exchangers, or steam
injection or infusion devices, which were usually coupled with vacuum
coolers. Commercial use of such equipment necessitated aseptic packaging
after sterilization, which proved to be the most serious limitation.
Early successes with milk and its products increased interest in adapt-
ing aseptic processing and packaging to other liquid foods. The book out-
lines progress with products such as soups, juices, and purees, and current
research and development directed toward the challenging problems with
foods containing solid particles. Introduction of new aseptic processing
and packaging technologies necessitated the evolution of a new body of
food laws and regulations, and new or expanded agencies to enforce them.
Innovations in the United States have been delayed by the industry’s justifi-
able cautious approach in developing validation procedures for compliance
with its own quality and safety standards, and those of regulatory agen-
cies. Collaboration among industry, industry organizations, public officials,
and agencies has been excellent in guiding the development of a rapidly
expanding industry based on aseptic processing and packaging.
The organization of the book permits readers to selectively choose
those sections in which they have the greatest interest. The sections
written by the different authors reflect their personal styles and areas
of expertise. The book provides a comprehensive update on this rapidly
developing technology for the food processing industry.
We wish to express our sincere appreciation to the four contributing
authors Dr. Robert Fox, Dr. Pablo Coronel, Dr. Josip Simunovic, and Dr. Kenneth
Swartzel, who, by giving freely of their expertise, have made this book pos-
sible. Many thanks are due to Steve Zollo, senior editor, Taylor & Francis/CRC
Press, Boca Raton, Florida, for his professionalism and unstinting support in
bringing this book to publication. Our appreciation to David Fausel and Linda
Leggio at Taylor & Francis/CRC Press for expediting the final stage of printing.
Jairus R.D. David
Omaha, Nebraska
Ralph H. Graves
Visalia, California
Thomas Szemplenski
San Diego, California
Note: References to commercial products and trade names are made with
the understanding that no discrimination and/or no endorsement by
the authors or the organizations that they are involved with are implied.
Acknowledgments
I would like to express my thanks to the following: my wife, Shelley, for
her loving encouragement of this work, and to our children, Adriana,
Brennan, and Blake, for “daring” me to write “another book.”
Dr. Al Bolles, Senior Executive Vice President of Research, Quality,
and Innovation (RQI), and Dr. Corey Berends, Vice President, Innovation,
RQI, for their visionary leadership and encouragement of this work.
Dr. Richard McArdle, Vice President, RQI, for espousing the value of
“Leader Level 5,” and active listening. Dr. Athula Ekanayake, Research
Fellow, at the Procter & Gamble Company, for introducing me to the
Minto pyramid principle and logic, and to the world of natural antimicro-
bials and delivery systems.
Dr. Kailash Purohit, President and CEO of Process Tek, Prospect
Heights, Illinois, who single-handedly coined and articulated the terms
“aseptic sterile work zone,” “maintenance sterility,” and “passive or
dynamic decontamination” in both the pharmaceutical and food indus-
tries. His review of Chapters 9, 11, 12, 13, and 15, and useful discussions
are acknowledged.

Jairus R.D. David

My family for their constructive criticism.


Jody and Robert Graves for their good memories and expertise.
My fellow authors—Jairus David and Thomas Szemplenski.

Ralph H. Graves

I would like to express my special appreciation to the following people:


Dr. Philip Nelson of Purdue University for giving me the opportunity
to participate in the development of aseptic bag-in-box and bulk storage,
and his mentoring over the course of my career.
Dr. Dilip Chandarana for being a very special friend and source of
aseptic and other food technology over the years.

xxi
xxii Acknowledgments

Darryl Wernimont, Director of the Haskell Co., for his longtime


friendship.
Malcom Knight, Vice President of Pom Wonderful, for his support
of me to facilitate his company’s aseptic processing and packaging
objectives, and experience hands-on installation of an aseptic rotary
bottle filler.

Thomas Szemplenski
Authors
Jairus R.D. David, M.Sc., Ph.D., is Senior Principal Research Scientist,
Innovation—Breakthrough Science, Research, Quality, and Innovation
(RQI), ConAgra Foods headquartered in Omaha, Nebraska. David’s
responsibilities include science leadership and development of inter-
vention technologies for food protection, and process and quality
optimization.
David is a Fellow of the Institute of Food Technologists (IFT), 2008,
and is the recipient of IFT’s prestigious Industrial Scientist Award, 2006.
He is recognized for developing and influencing public health food safety
policy on the use of honey in cereals and bakery products for the preven-
tion of infant botulism in infants under 12 months of age. Currently, all
honey and honey-containing food products in commerce carry a warning
label “Do not feed honey to infants less than one year of age.”
David has 20-plus years of food industry management and leadership
experience in the areas of food safety, thermal processing, aseptic technol-
ogy, quality assurance, and risk analysis. Prior to this, he worked at Real
Fresh Aseptic Operations in Visalia, California, and Gerber Baby Foods in
Fremont, Michigan.
David earned his Ph.D. in microbiology with emphasis in thermal pro-
cessing from the University of California at Davis, under the tutelage of
Dr. Richard Larry Merson. He is a Certified Quality Manager (CQM) and
Certified Quality Engineer (CQE), American Society for Quality. David has
participated in the leadership development program at the Kellogg School
of Management, Dr. Stephen Covey Leadership Center, Massachusetts
Institute of Technology, and Center for Creative Leadership.

Ralph H. Graves held the position of Senior Vice President for Real Fresh,
Inc., a company involved in the processing and sale of aseptically pack-
aged foods. His responsibilities included the research and development
of processing techniques, quality control, engineering, and maintenance
and warehousing of aseptically packaged dairy products. Prior to his
employment with Real Fresh, Graves was involved in the startup of several

xxiii
xxiv Authors

ultra-high temperature (UHT) milk processing plants for International


Milk Processors, Inc., one of the first U.S. companies devoted entirely to
aseptic packaging. He majored in animal science and dairy production at
Valparaiso and Michigan State universities. His interest in aseptic packag-
ing came from his father, who was one of the pioneers in the field of UHT
sterilization, holding several patents related to the process.
Graves’ career has taken him around the world, from working as
President of Graves Farm, Inc., in Maryland, to overseeing the produc-
tion and distribution of aseptically packaged foods overseas. Milestones
include assisting in the startup of a joint venture between Real Fresh and
the Murray Goldburn Dairy Cooperative in Australia, and overseeing the
distribution of Real Fresh milk for the first Saudi Arabian school lunch
program. Although now officially retired, he continues his work in this
field as a consultant for Real Fresh and other firms.
Graves’ involvement in professional organizations includes: Chair
of the Aseptic Packaging Committee of the National Food Processors
Association (now Grocery Manufacturers Association [GMA]); Past
President of the California Creamery Operators Association; Director
and Secretary–Treasurer of the California Dairy Institute; member of the
Scientific Affairs Committee of the National Food Processors Association;
President of Visalia Kiwanis Club; President of California Backcountry
Horsemen; and Treasurer and Director of Visalia, California Chamber
of Commerce.

Thomas Szemplenski is currently the owner of Aseptic Resources, Inc., a


consulting company dedicated to assisting food processors and equipment
manufacturers with aseptic processing techniques. He has more than four
decades of food processing and packaging experience. The vast majority
of those years have been dedicated to aseptic processing and packaging
techniques, commercial application, and marketplace dynamics.
Prior to starting Aseptic Resources in 1987, Szemplenski initially
worked for a frozen food manufacturer and after attending the University
of Nebraska, he went on to hold senior marketing positions with several
leading manufacturers of food processing equipment, affording world-
wide exposure to many different aseptic processing and packaging alter-
natives. In addition, while in these marketing positions, Szemplenski
was very fortunate to work and learn from Dr. Phil Nelson of Purdue
University and William Scholle with the initial development of aseptic
packaging of food products into bag-in-box. Subsequently, he has actively
participated in many commercial aseptic processing and packaging sys-
tems using bag-in-box fillers.
Authors xxv

A number of years ago, while continuing Aseptic Resources,


Szemplenski concurrently was a part owner of an aseptic processing facil-
ity located in the Midwest. This facility aseptically contract packaged both
high- and low-acid food products under FDA validation.
Szemplenski has published numerous papers during his professional
career primarily dealing with aseptic processing and packaging tech-
niques, and he has been invited to teach aseptic processing techniques
at several leading universities and major food processors. Additionally,
Szemplenski holds several patents centered on aseptic technology.
Contributing Authors
Pablo M. Coronel, Ph.D. Josip Simunovic, Ph.D.
R&D Department of Food Bioprocessing
Aseptia, Inc.   and Nutrition Sciences
Raleigh, North Carolina North Carolina State University at
  Raleigh
Robert Fox, Ph.D. Raleigh, North Carolina
Synergy Packaging, LLC
Williamsburg, Virginia Kenneth R. Swartzel, Ph.D.
William Neal Reynolds
  Distinguished Professor Emeritus
North Carolina State University at
  Raleigh
Raleigh, North Carolina

xxvii
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