Validation of Food Preservation Processes based on Novel Technologies

Front Cover
Validation of Food Preservation Processes Based on Novel Technologies
Copyright Page
Dedication
Contents
List of contributors
Preface
Introduction
1 History of thermal process validation and verification
1.1 Approaches to thermal process validation
1.2 Establishment of the preservation process
2 Nonthermal technologies and challenges of validation of novel processes compared to thermal processing
2.1 Review of fundamental principles
2.2 Challenges and perspectives of commercial implementation
2.3 Production benefits
3 Validation and verification as requirements of food safety regulations
3.1 New definition of pasteurization
References
Further reading
1 General principles and approaches of food process validation
1.1 General principles and approaches of food process validation
1.1.1 Validation concept and terminology
1.1.2 Verification versus validation versus monitoring
1.1.3 Validation at different phases of process development
1.1.4 Scale-up process
1.1.5 Key components of validation procedures
1.1.6 Physical validation
1.1.6.1 Process uniformity evaluation
1.1.7 Microbiological validation
1.1.7.1 Challenge studies
1.1.7.1.1 Pertinent pathogen(s) selection
1.1.7.2 Microbiological methods
1.1.7.2.1 Inoculum Levels
1.1.7.2.2 Model systems
1.1.7.3 Microbial validation in process scale-up and use of surrogate organisms
1.1.7.4 Criteria for selecting pathogen surrogates
1.1.8 Quality validation
1.1.8.1 Quality, nutritional content, shelf-life and sensory studies, packaging
1.1.8.2 Chemical and physical safety
1.1.9 Equipment validation
1.1.10 Cleaning and sanitation validation
1.1.11 Facility requirements
1.1.12 Documentation
1.1.13 Role of process authority in the era of emergent novel and nonthermal preservation technologies
1.1.14 Requirements for processing authorities [21 CFR113.83 and 113.89]
1.1.14.1 Novel and nonthermal processing technologies
1.1.14.1.1 Process adherence
1.2 Conclusions
References
2 Validation of high hydrostatic pressure process
2.1 History and introduction to high-pressure processing technology for foods
2.2 Fundamentals of HHP
2.2.1 HHP principle of operation
2.2.1.1 Types of high-pressure processing
2.2.1.1.1 High-pressure pasteurization
2.2.1.1.2 Pressure-assisted thermal processing or pressure-assisted thermal sterilization
2.2.2 HHP commercial applications
2.2.2.1 HHP-enabled product innovation
2.2.3 HHP microbiological effects
2.2.3.1 Mode of inactivation of microbes by HHP
2.2.3.2 HHP barotolerance
2.2.3.3 Matrix effects on barotolerance of bacterial cells
2.2.3.4 Pretreatment culture conditions on barotolerance
2.2.3.5 Posttreatment storage and recovery
2.2.4 HHP quality effects
2.2.5 HHP effects on allergens
2.2.6 HHP effects on patulin mycotoxin
2.2.7 HHP effects on enzymes
2.3 HHP critical product and process parameters
2.3.1 Product parameters
2.3.1.1 pH
2.3.1.2 Water activity
2.3.1.3 Fat or oil content of the food
2.3.1.4 Physical properties of foods under high pressure
2.3.1.5 Compressibility
2.3.1.6 Thermal conductivity
2.3.1.7 Specific heat
2.3.1.8 Density
2.3.2 Process parameters
2.3.2.1 Time
2.3.2.2 Temperature
2.4 Packaging
2.4.1 Requirements and types of packages
2.4.1.1 Requirements for plastic packaging materials
2.4.2 Food contact compliance
2.4.3 Packaging validation
2.5 HHP commercial systems
2.5.1 Design
2.5.2 Pressure vessels
2.5.3 Commercial HHP manufacturers
2.5.3.1 Semicontinuous HHP for beverages
2.5.3.2 Continuous “in-bulk” HHP
2.5.4 Scalability of pilot and commercial-scale HHP processes
2.5.5 Calibration and maintenance of HHP systems
2.6 International regulatory requirements
2.6.1 Australia and New Zealand
2.6.2 Canada
2.6.3 European Union
2.6.4 United States
2.7 Microbiological challenge testing
2.7.1 Shelf-life validation
2.7.1.1 Product
2.7.1.2 Process
2.7.1.3 Test
2.7.2 Safety validation
2.7.3 Surrogate organisms
2.8 Commercial HHP trials
2.8.1 Juices
2.8.2 Meats
2.8.3 Deli salads, hash browns, herbs, and gravy base
2.9 Responsibilities for contract of HHP facility
2.9.1 Deviation from the validated process
2.10 Future prospects and gaps in HHP technology development
References
Further reading
3 Case study of validation of high hydrostatic pressure processing of fruit and vegetable smoothies in PET bottles
3.1 Product description
3.2 Packaging
3.3 HPP unit
3.4 Methodology
3.5 Sampling plan
3.6 Test procedures
3.7 Source of pathogens
3.8 Cultivation, enumeration, and enrichment protocols for model microbes
3.9 HPP operation procedure
3.10 Results
3.11 Conclusion
References
4 Validation of light-based processes
4.1 History and introduction to fundamentals of ultraviolet light and pulsed light technology for food applications
4.2 Continuous UV, pulsed, and LED light sources
4.3 International regulatory requirements
4.3.1 US Food and Drug Administration: food additive approach
4.3.1.1 Continuous UVC light
4.3.1.1.1 Juice products
4.3.1.1.2 Surface and potable water
4.3.1.1.3 UV-pasteurized water for dairy industry
4.3.1.1.4 Baking yeasts
4.3.1.2 Pulsed UV light in the production, processing, and handling of food
4.3.2 Novel food regulations
4.3.2.1 Canada
4.3.2.1.1 Apple juice and cider
4.3.2.2 European Union
4.3.2.2.1 Milk
4.3.2.2.2 Bread
4.4 Validation of UV light technologies for surface treatment
4.4.1 UV disinfection efficiency of surfaces and limiting factors
4.4.2 Advantages and disadvantages of high-intensity pulses
4.4.2.1 Factors affecting interaction between high-intensity pulses and materials
4.4.3 Establishing steps and validation of surface treatment process
4.4.4 Critical process and control parameters
4.4.5 Commercial UV and pulsed light systems for surface treatment
4.4.6 Case studies of pulsed and continuous UV surface treatment
4.5 Validation of UV light preservation processes for liquid products and beverages
4.5.1 Requirements for UVC preservation of beverages
4.5.2 Establishment of preservation reduction equivalent UVC dose
4.5.2.1 Physico-chemical and optical properties of opaque liquids
4.5.2.2 pH, Brix, UV transmittance, turbidity, and viscosity
4.5.3 Principles of validation of UVC preservation process for liquids and beverages
4.5.3.1 UV energy, fluence, and germicidal dose in water and opaque liquids
4.5.3.2 UV Batch system
4.5.3.3 UV Continuous systems
4.5.3.4 Terminology and evaluation of UV dose in water treatment practices
4.5.3.5 Biodosimetry studies and challenges for low-UV transmittance liquids
4.5.3.6 Surrogate or indicator organisms
4.5.3.7 UVC impact on quality, composition, and sensory
4.5.3.8 Chemical and physical safety
4.5.3.9 Chemical actinometry
4.5.3.10 Mathematical modeling
4.5.3.11 Hydraulic considerations
4.5.3.12 Design of commercial UVC systems
4.5.4 Validation of commercial UV equipment and process controls
4.5.4.1 Critical process parameters and ways of their monitoring
4.5.4.2 UV transmittance
4.5.4.3 Turbidity
4.5.4.4 Flow rate and pattern
4.5.4.5 Fluid dynamics and Reynolds number
4.5.4.6 Pressure
4.5.4.7 Process and product temperature
4.5.4.8 UV lamp intensity
4.5.4.9 UV sensors
4.5.4.10 Validation of commercial UV systems for low-UV transmittance liquid products
4.6 Conclusion
References
5 Case study of validation of ultraviolet light pasteurization of sugar syrups
5.1 Evaluation of ultraviolet dose in commercial ultraviolet system
5.1.1 Experimental approach
5.1.1.1 UV light treatment unit
5.1.1.2 UV lamps
5.1.1.3 UV light unit experimental configurations
5.1.1.4 Test products
5.1.1.5 Physical and optical characteristic measurements
5.1.1.6 Inoculum preparation
5.1.1.7 Preliminary experiments to determine stability of spores in syrups
5.1.1.8 Product inoculation
5.1.1.9 UV treatment
5.1.1.10 Sampling
5.1.1.11 Enumeration of B. subtilis
5.1.1.12 Fastest moving particle studies
5.1.2 Results
5.1.2.1 Absorptive and physical properties of liquid sucrose and HFCS
5.1.2.2 Flow dynamics
5.1.2.3 Residence time evaluation
5.1.2.4 Spore recovery from sugar syrups
5.1.2.5 B. subtilis spores inactivation
5.1.3 Mathematical modeling of UV fluence rate
5.1.3.1 Single-lamp UV reactor
5.1.3.2 Multiple-lamp UV reactor
5.1.3.3 Decimal reduction UV dose evaluation
5.1.3.4 Mathematical calculations
5.1.3.5 Biodosimetry approach of UV dose evaluation in the multiple-lamp UV reactor
5.1.3.6 Numerical simulation of distribution of sucrose velocity and spores’ survivors in a 7-lamp UV reactor configuration
5.1.4 Conclusions
5.2 UV dose verification studies in commercial-scale system
5.2.1 Background
5.2.2 Materials and methodologies
5.2.2.1 UV processing equipment
5.2.2.2 Specifications of UV reactor
5.2.2.3 UV lamp
5.2.2.4 Measurements of UV fluence rate on the surface of UV lamps
5.2.2.5 Pump flow rate calibration
5.2.2.6 Test product
5.2.2.7 Optical and physical product parameters
5.2.2.8 Test microorganisms
5.2.2.9 Inoculum preparation
5.2.2.9.1 Bacillus subtilis
5.2.2.9.2 Product inoculation
5.2.2.10 Processing parameters
5.2.2.11 Sampling
5.2.2.12 Enumeration procedures
5.2.3 Results
5.2.3.1 Sucrose absorbance
5.2.3.2 UV fluence determination
5.2.3.3 UV inactivation kinetics of B. subtilis spores
5.2.3.4 UV dose delivered by the pilot-scale 7-lamp UV reactor
5.2.3.5 Modeling of UV inactivation kinetics of B. subtilis spores
5.2.3.6 First-order inactivation model
5.2.3.7 Series-event inactivation model
5.2.4 Conclusion
5.3 UV inactivation of pathogenic and spoilage organisms in liquid sucrose
5.3.1 Methodology
5.3.1.1 Test organisms
5.3.1.2 Preliminary experiments to determine stability of pathogens in sucrose syrup
5.3.1.3 Preliminary experiments to determine distribution of mold spores in sucrose syrup
5.3.1.4 Pathogens
5.3.1.5 Yeast and molds
5.3.1.6 Recovery of test microorganisms from sucrose syrup (preliminary studies)
5.3.2 Results
5.3.3 Conclusions
References
6 Overview of other novel processes and validation approaches
6.1 Introduction
6.2 Radiation, regulations, and validation
6.2.1 Gamma rays
6.2.2 X-rays and e-beams
6.2.3 Safety of irradiation
6.2.4 Validation and verification of food irradiation process
6.2.5 Irradiation facility
6.2.6 International regulations and standards
6.3 Advanced radiative and electromagnetic heating technologies
6.3.1 Infrared
6.3.2 Ohmic
6.3.3 Magnetic induction
6.3.4 Microwave
6.3.5 Radiofrequency
6.3.6 Validation principles of microwave and radiofrequency heating
6.3.6.1 Microwave process lethality
6.3.6.2 Microwave heating characteristics
6.3.6.3 Validation testing
6.4 Cold atmospheric plasma
6.4.1 Validation challenges
6.4.2 Regulations and commercialization
References
Conclusions
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Step 8
Step 9
Step 10
Verification
Step 11
Other considerations
Step 12
Process deviations
Index
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