Practical Guide to Validation of Aseptic Processing and Packaging
Editat de Dharmendra K. Mishra, Patnarin Benyathiar, Ferhan Ozadali, Jairus R. D. Daviden Limba Engleză Hardback – 18 feb 2027
Key Features:
- Covers qualification and commissioning of the aseptic processing systems
- Includes microbiological validation of sterilization system, aseptic tank, and aseptic filling machine
- Covers regulatory crieteria for aseptic food manufacturing
- Outlines the requirements to maintain the sterile conditions and commercialization
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Specificații
ISBN-13: 9781041133377
ISBN-10: 1041133375
Pagini: 264
Ilustrații: 134
Dimensiuni: 178 x 254 mm
Ediția:1
Editura: CRC Press
Colecția CRC Press
ISBN-10: 1041133375
Pagini: 264
Ilustrații: 134
Dimensiuni: 178 x 254 mm
Ediția:1
Editura: CRC Press
Colecția CRC Press
Public țintă
Professional Practice & DevelopmentCuprins
Chapter 1 – Fundamentals of Establishing Validated State for Aseptic Processing and Packaging Systems
By Dharmendra K. Mishra, Patnarin Benyathiar, Ferhan Ozdali, and Jairus R. D. David
Chapter 2 – Regulatory Aspects of Validation: Industry Due Diligence for Compliance
By Jairus R. D. David, Dharmendra K. Mishra, and Nathan M. Anderson
Chapter 3 – Master Validation Plan
By Dharmendra K. Mishra and Ferhan Ozdali
Chapter 4 – Building and Utilities
By Eric Woodworth and Pablo M. Coronel
Chapter 5 – Controls Validation
By Kaan Ozdali, Ben Paxson, and Eric Woodworth
Chapter 6 – Kinetics of Spore Inactivation in Aseptic Processing for Validation
By Manoj Sawale, Kirk D. Dolan, and Dharmendra Mishra
Chapter 7 – Validation of Sterilization Equipment and Process
By Pablo Coronel, Corpus Perez, and Dharmendra Mishra
Chapter 8 – Validation of Aseptic Tank and End-of-Line Valve Cluster
By Dharmendra Mishra and Ferhan Ozdali
Chapter 9 – Sterile Barriers Design and Validation: Aseptic Barrier Design, Operational Controls, and Deviation Management
By Ferhan Ozdali and Eric Woodworth
Chapter 10 – Aseptic Filler Machine Pre Production Sterilization and Aseptic Zone Validation
By Corpus Perz, Patnarin Benyathiar, and Dharmendra Mishra
Chapter 11 – Aseptic Packaging Qualification and Validation
By Patnarin Benyathiar and Dharmendra Mishra
Chapter 12 – Particulate Aseptic Process Validation
By Dharmendra K. Mishra, Pablo Coronel, and Josip Simunovic
Chapter 13 – Validation of Cleaning and Sanitation
By Rahul Kamath and Jeffrey Merritt
Chapter 14 – FDA Fiing for Aseptically Processed Low-Acid Foods (LACF): Process Filing Logic, Documentation, and Practical Examples
By Ferhan Ozdali and Dharmendra Mishra
Chapter 15 – Qualification and Validation of Incoming Materials
By Jairus R. D. David, Tyler Dixon, and Dharmendra K. Mishra
Chapter 16 – Validation of Food Safety and Quality Methodologies
By Tyler Dixon and Manoj Sawale
Chapter 17 – Development of Positive Release Criteria and Audit Readiness
Chapter 18 – Process Deviation Analysis & Investigation of Food Spoilage Caused by Microorganisms
By Jairus R> D. David, Dharmendra K. Mishra, Pablo Coronel, and Corpus Perez
Chapter 19 – Validated State and Operational Readiness
By Amandeep Singh, Harneel Kaur, and Corpus Perez
Chapter 20 – Conclusion and Perspectives
By Dharmendra Mishra, Patnarin Benyathiar, Ferhan Ozdali, and Jairus R. D. David
By Dharmendra K. Mishra, Patnarin Benyathiar, Ferhan Ozdali, and Jairus R. D. David
Chapter 2 – Regulatory Aspects of Validation: Industry Due Diligence for Compliance
By Jairus R. D. David, Dharmendra K. Mishra, and Nathan M. Anderson
Chapter 3 – Master Validation Plan
By Dharmendra K. Mishra and Ferhan Ozdali
Chapter 4 – Building and Utilities
By Eric Woodworth and Pablo M. Coronel
Chapter 5 – Controls Validation
By Kaan Ozdali, Ben Paxson, and Eric Woodworth
Chapter 6 – Kinetics of Spore Inactivation in Aseptic Processing for Validation
By Manoj Sawale, Kirk D. Dolan, and Dharmendra Mishra
Chapter 7 – Validation of Sterilization Equipment and Process
By Pablo Coronel, Corpus Perez, and Dharmendra Mishra
Chapter 8 – Validation of Aseptic Tank and End-of-Line Valve Cluster
By Dharmendra Mishra and Ferhan Ozdali
Chapter 9 – Sterile Barriers Design and Validation: Aseptic Barrier Design, Operational Controls, and Deviation Management
By Ferhan Ozdali and Eric Woodworth
Chapter 10 – Aseptic Filler Machine Pre Production Sterilization and Aseptic Zone Validation
By Corpus Perz, Patnarin Benyathiar, and Dharmendra Mishra
Chapter 11 – Aseptic Packaging Qualification and Validation
By Patnarin Benyathiar and Dharmendra Mishra
Chapter 12 – Particulate Aseptic Process Validation
By Dharmendra K. Mishra, Pablo Coronel, and Josip Simunovic
Chapter 13 – Validation of Cleaning and Sanitation
By Rahul Kamath and Jeffrey Merritt
Chapter 14 – FDA Fiing for Aseptically Processed Low-Acid Foods (LACF): Process Filing Logic, Documentation, and Practical Examples
By Ferhan Ozdali and Dharmendra Mishra
Chapter 15 – Qualification and Validation of Incoming Materials
By Jairus R. D. David, Tyler Dixon, and Dharmendra K. Mishra
Chapter 16 – Validation of Food Safety and Quality Methodologies
By Tyler Dixon and Manoj Sawale
Chapter 17 – Development of Positive Release Criteria and Audit Readiness
Chapter 18 – Process Deviation Analysis & Investigation of Food Spoilage Caused by Microorganisms
By Jairus R> D. David, Dharmendra K. Mishra, Pablo Coronel, and Corpus Perez
Chapter 19 – Validated State and Operational Readiness
By Amandeep Singh, Harneel Kaur, and Corpus Perez
Chapter 20 – Conclusion and Perspectives
By Dharmendra Mishra, Patnarin Benyathiar, Ferhan Ozdali, and Jairus R. D. David
Notă biografică
Dr. Dharmendra Mishra
Associate Professor, Purdue University
Dr. Mishra is an associate professor and Director of Food Entrepreneurship and Manufacturing Institute at the Department of Food Science, Purdue University. Dr. Mishra's extension and applied research are focused on commercial food manufacturing to advance food safety and quality for existing and novel thermal and non-thermal manufacturing technologies. Through a highly effective, self-sustaining extension model, Dr. Mishra integrates real-world industry challenges into academic training, preparing students while delivering measurable impact to stakeholders. He works closely with commercial food manufacturers and provides them operational guidance and design training courses for the workforce. The training includes topics such as Better Process Control School (required by the FDA), Aseptic Processing and Packaging, and Validation of Food Processes. He also works with the entrepreneurs and scales their product formulation to commercial production. The entrepreneurs are provided guidance on equipment selection, building design, installation, validation, plant sanitation, and regulatory filing.
Internationally recognized for his expertise in aseptic processing and packaging, Dr. Mishra is among a select group of researchers conducting microbiological validation for low-acid shelf-stable foods. Dr. Mishra earned his B.S in Agricultural Engineering from Tamil Nadu Agricultural University and received his M.S. and Ph.D. from Agricultural and Biosystems Engineering at Michigan State University. He worked in the food industry over eight years as a process engineer and process authority (Nestle Nutrition and Mead Johnson Nutrition) before joining Purdue University in 2016. He also serves on the Board of the Institute for Thermal Processing Specialists (IFTPS). He has several journal article publications, book chapters, patents, and invited presentations from international organizations.
Dr. Mishra’s work has had a transformative impact on the food industry, contributing to large manufacturing investments and enabling companies to scale operations and innovate new products. His leadership has strengthened partnerships with major food and equipment manufacturers while advancing workforce development.
Driven by a vision to bridge the gap between research and commercialization, Dr. Mishra continues to lead initiatives aimed at developing state-of-the-art pilot facilities and educational programs. His work not only enhances food safety and manufacturing innovation but also shapes the next generation of leaders in the global food industry.
Patnarin Benyathiar, Ph.D.
Dr. Patnarin Benyathiar is currently a Clinical Assistant Professor of Food Packaging in the Department of Food Science, Purdue University. She earned her M.S. and Ph.D. from Michigan State University and worked in the food industry for several years (Nestle Nutrition and Mead Johnson Nutrition) as a packaging engineer for aseptic processing and packaging projects.
After her food industry work, Dr. Benyathiar returned to her alma mater, Mahidol University, where she served as an Assistant Professor in the Department of Food Science. Her role involves both teaching and research, and she has become a prominent figure in the field of food packaging. Dr. Benyathiar’s research interests are centered on aseptic processing and packaging, a critical area in ensuring the safety and longevity of food products. Her work addresses challenges such as improving the efficiency of aseptic processing techniques and developing new packaging materials that enhance food preservation while reducing environmental impact. She has published numerous articles in leading scientific journals and has been invited to present her findings at international conferences.
Dr. Benyathiar is renowned for her innovative approach to food packaging and her dedication to advancing food safety practices. Her research has led to practical applications that benefit both consumers and the food industry, including improvements in packaging materials and processing methods. In addition to her research, Dr. Benyathiar is committed to education and mentorship. She is known for her engaging teaching style and for inspiring the next generation of food scientists and engineers. Her students appreciate her practical insights and the real-world applications of her research. Dr. Benyathiar’s commitment to her field extends beyond the classroom and laboratory. She actively collaborates with industry partners and participates in various professional organizations to stay at the forefront of emerging trends and technologies in food packaging.
Ferhan Ozadali, Ph.D.
Dr. Ferhan Ozadali is Vice President of Technical Affairs at Trilliant Food and Nutrition, specifically, accountable for R&DI, Regulatory, Engineering, and Process Authority Services. Until recently, Ferhan was working as a Director of Global R&D at Mead Johnson Nutrition, a Division of Reckitt Nutrition, and looking after Global Engineering, Process Authority Services, and Clinical Manufacturing.
With his nearly 30 years of experience and ability to recruit top talents from the industry and academia, Ferhan successfully created top performing teams and took the accountability of leading major processing and packaging capital initiatives. He was instrumental for the justification, design, and installation of processing and packaging technologies that provides companies world-class capabilities globally. His active roles in the industry and academia allow him to utilize his connections and lead business-critical partnerships/collaborations in innovative technology areas. Ferhan has always kept his close connection to the academia. He is an Adjunct Professor and Departmental Advisory Board Member at the Food Science Department, Purdue University.
Before joining Mead Johnson Nutrition, Ferhan led North America Quality and Food Safety Excellence and Contract Manufacturing Quality at Ocean Spray, Lakeville, MA.
Ferhan worked as a Global Process Authority and led the Strategic Technology and Process Development at Nestlé Nutrition, Product Technology Center and served as Nestlé Aseptic and Thermal Process Expert in Global network core teams. He led research projects in Thermal and Aseptic Strategic Processes with the focus on Alternative product and packaging sterilization technologies. His expertise are in new technology/process development, regulatory compliance, qualification, validation, and quality management systems. During his tenure at Nestle, he served as Adjunct Faculty at the Michigan State University, Food Science and Human Nutrition and Biosystems Engineering Departments with dual appointments.
Prior to joining Nestlé/Gerber, Ferhan worked as the Corporate Director of R&D and Quality at the Hirzel Canning Company which is a farming, canning, and food processing company, located in Toledo, Ohio. During his tenure at HCC, he served as Adjunct Faculty at the Bowling Green State University, Food and Nutrition Department.
Ferhan previously worked for The Ohio State University, Food Science and Technology Department with the research focus in Aseptic Processing and Packaging. He received his MS in Food Science and Technology and Ph.D. in Food Science and Technology and Chemical Engineering degrees with studies in industrial fermentation processes at Iowa State University, Ames, Iowa. He received his BS degree in Food Engineering from the Middle East Technical University (METU) in Ankara, Turkey. Ferhan has several peer-reviewed publications, book and book chapters, and patents.
Jairus R. D. David, Ph.D.
Jairus R. D. David, Ph.D., is an expert on food preservation science, food safety, and quality. His industrial experience spans family-owned small companies and large corporations—highly regulated baby foods, infant formula, consumer-packaged goods, and food service. Jairus has worked with the food industry in developing microbiology and thermal processing food safety objectives and compliance for canning and aseptic processing for over 38 years, balancing applied research with process and quality optimization, and launch of innovative products. He has developed natural and clean label ingredients systems, especially antimicrobial preservatives for designing minimally processed foods.
Jairus earned his Ph.D. in microbiology with emphasis on thermal processing from the University of California at Davis. A Fellow of the Institute of Food Technologists (IFT, 2008), he is the recipient of IFT’s Industrial Scientist Award (2006).
Jairus has participated in the leadership programs at the Kellogg School of Management, Center for Creative Leadership, Stephen Covey Leadership Forum, the Philip Crosby Quality College, Rollins School of Public Health, and the Massachusetts Institute of Technology. Jairus is a Certified Quality Manager (CQM) and Certified Quality Engineer (CQE), from American Society for Quality (ASQ).
Associate Professor, Purdue University
Dr. Mishra is an associate professor and Director of Food Entrepreneurship and Manufacturing Institute at the Department of Food Science, Purdue University. Dr. Mishra's extension and applied research are focused on commercial food manufacturing to advance food safety and quality for existing and novel thermal and non-thermal manufacturing technologies. Through a highly effective, self-sustaining extension model, Dr. Mishra integrates real-world industry challenges into academic training, preparing students while delivering measurable impact to stakeholders. He works closely with commercial food manufacturers and provides them operational guidance and design training courses for the workforce. The training includes topics such as Better Process Control School (required by the FDA), Aseptic Processing and Packaging, and Validation of Food Processes. He also works with the entrepreneurs and scales their product formulation to commercial production. The entrepreneurs are provided guidance on equipment selection, building design, installation, validation, plant sanitation, and regulatory filing.
Internationally recognized for his expertise in aseptic processing and packaging, Dr. Mishra is among a select group of researchers conducting microbiological validation for low-acid shelf-stable foods. Dr. Mishra earned his B.S in Agricultural Engineering from Tamil Nadu Agricultural University and received his M.S. and Ph.D. from Agricultural and Biosystems Engineering at Michigan State University. He worked in the food industry over eight years as a process engineer and process authority (Nestle Nutrition and Mead Johnson Nutrition) before joining Purdue University in 2016. He also serves on the Board of the Institute for Thermal Processing Specialists (IFTPS). He has several journal article publications, book chapters, patents, and invited presentations from international organizations.
Dr. Mishra’s work has had a transformative impact on the food industry, contributing to large manufacturing investments and enabling companies to scale operations and innovate new products. His leadership has strengthened partnerships with major food and equipment manufacturers while advancing workforce development.
Driven by a vision to bridge the gap between research and commercialization, Dr. Mishra continues to lead initiatives aimed at developing state-of-the-art pilot facilities and educational programs. His work not only enhances food safety and manufacturing innovation but also shapes the next generation of leaders in the global food industry.
Patnarin Benyathiar, Ph.D.
Dr. Patnarin Benyathiar is currently a Clinical Assistant Professor of Food Packaging in the Department of Food Science, Purdue University. She earned her M.S. and Ph.D. from Michigan State University and worked in the food industry for several years (Nestle Nutrition and Mead Johnson Nutrition) as a packaging engineer for aseptic processing and packaging projects.
After her food industry work, Dr. Benyathiar returned to her alma mater, Mahidol University, where she served as an Assistant Professor in the Department of Food Science. Her role involves both teaching and research, and she has become a prominent figure in the field of food packaging. Dr. Benyathiar’s research interests are centered on aseptic processing and packaging, a critical area in ensuring the safety and longevity of food products. Her work addresses challenges such as improving the efficiency of aseptic processing techniques and developing new packaging materials that enhance food preservation while reducing environmental impact. She has published numerous articles in leading scientific journals and has been invited to present her findings at international conferences.
Dr. Benyathiar is renowned for her innovative approach to food packaging and her dedication to advancing food safety practices. Her research has led to practical applications that benefit both consumers and the food industry, including improvements in packaging materials and processing methods. In addition to her research, Dr. Benyathiar is committed to education and mentorship. She is known for her engaging teaching style and for inspiring the next generation of food scientists and engineers. Her students appreciate her practical insights and the real-world applications of her research. Dr. Benyathiar’s commitment to her field extends beyond the classroom and laboratory. She actively collaborates with industry partners and participates in various professional organizations to stay at the forefront of emerging trends and technologies in food packaging.
Ferhan Ozadali, Ph.D.
Dr. Ferhan Ozadali is Vice President of Technical Affairs at Trilliant Food and Nutrition, specifically, accountable for R&DI, Regulatory, Engineering, and Process Authority Services. Until recently, Ferhan was working as a Director of Global R&D at Mead Johnson Nutrition, a Division of Reckitt Nutrition, and looking after Global Engineering, Process Authority Services, and Clinical Manufacturing.
With his nearly 30 years of experience and ability to recruit top talents from the industry and academia, Ferhan successfully created top performing teams and took the accountability of leading major processing and packaging capital initiatives. He was instrumental for the justification, design, and installation of processing and packaging technologies that provides companies world-class capabilities globally. His active roles in the industry and academia allow him to utilize his connections and lead business-critical partnerships/collaborations in innovative technology areas. Ferhan has always kept his close connection to the academia. He is an Adjunct Professor and Departmental Advisory Board Member at the Food Science Department, Purdue University.
Before joining Mead Johnson Nutrition, Ferhan led North America Quality and Food Safety Excellence and Contract Manufacturing Quality at Ocean Spray, Lakeville, MA.
Ferhan worked as a Global Process Authority and led the Strategic Technology and Process Development at Nestlé Nutrition, Product Technology Center and served as Nestlé Aseptic and Thermal Process Expert in Global network core teams. He led research projects in Thermal and Aseptic Strategic Processes with the focus on Alternative product and packaging sterilization technologies. His expertise are in new technology/process development, regulatory compliance, qualification, validation, and quality management systems. During his tenure at Nestle, he served as Adjunct Faculty at the Michigan State University, Food Science and Human Nutrition and Biosystems Engineering Departments with dual appointments.
Prior to joining Nestlé/Gerber, Ferhan worked as the Corporate Director of R&D and Quality at the Hirzel Canning Company which is a farming, canning, and food processing company, located in Toledo, Ohio. During his tenure at HCC, he served as Adjunct Faculty at the Bowling Green State University, Food and Nutrition Department.
Ferhan previously worked for The Ohio State University, Food Science and Technology Department with the research focus in Aseptic Processing and Packaging. He received his MS in Food Science and Technology and Ph.D. in Food Science and Technology and Chemical Engineering degrees with studies in industrial fermentation processes at Iowa State University, Ames, Iowa. He received his BS degree in Food Engineering from the Middle East Technical University (METU) in Ankara, Turkey. Ferhan has several peer-reviewed publications, book and book chapters, and patents.
Jairus R. D. David, Ph.D.
Jairus R. D. David, Ph.D., is an expert on food preservation science, food safety, and quality. His industrial experience spans family-owned small companies and large corporations—highly regulated baby foods, infant formula, consumer-packaged goods, and food service. Jairus has worked with the food industry in developing microbiology and thermal processing food safety objectives and compliance for canning and aseptic processing for over 38 years, balancing applied research with process and quality optimization, and launch of innovative products. He has developed natural and clean label ingredients systems, especially antimicrobial preservatives for designing minimally processed foods.
Jairus earned his Ph.D. in microbiology with emphasis on thermal processing from the University of California at Davis. A Fellow of the Institute of Food Technologists (IFT, 2008), he is the recipient of IFT’s Industrial Scientist Award (2006).
Jairus has participated in the leadership programs at the Kellogg School of Management, Center for Creative Leadership, Stephen Covey Leadership Forum, the Philip Crosby Quality College, Rollins School of Public Health, and the Massachusetts Institute of Technology. Jairus is a Certified Quality Manager (CQM) and Certified Quality Engineer (CQE), from American Society for Quality (ASQ).
Descriere
This guide provides aseptic validation techniques for the food and pharmaceutical industry. The contents follow the well-established Purdue Aseptic Processing and Packaging Validation Workshop. Readers will be able to follow the steps outlined in different chapters and learn about qualification and validation of aseptic processing lines.