Handbook Of Aseptic Processing And Packaging

Cover
Half Title
Title Page
Copyright Page
Table of Contents
Foreword
Preface
Acknowledgments
Editors
Contributors
PART I Fundamentals and Frontiers, Framework for Regulations, and Marketing
Chapter 1 Aseptic Processing and Packaging: Fundamentals and Frontiers
1.1 Introduction
1.2 Framework and Current State
1.3 Departures from Optima and Challenges
1.4 Current and Future Opportunities for Optimization
1.5 Summary
References
Chapter 2 US Federal Regulations for Aseptic Processing and Packaging of Food
2.1 Introduction
2.2 US FDA Regulations
2.2.1 Facility Registration and Product Filing
2.2.2 Better Process Control School
2.2.3 Process Authority
2.2.4 Low-Acid Foods Packaged in Hermetically Sealed Containers
2.2.5 Pasteurized Milk Ordinance
2.2.6 Acidified Foods
2.2.7 Process Filing Forms
2.2.8 Preventive Controls for Human Foods
2.2.9 Aseptic Packaging Materials as Indirect Food Additives
2.3 USDA Regulations
2.4 Conclusion
References
Chapter 3 The US Markets for Aseptically Processed and Packaged Products
3.1 Development
3.2 Aseptic Metal Can Market
3.3 Aseptic Bag-In-Box
3.4 Aseptic Paperboard Market
3.5 Aseptic Plastic Cup Market
3.6 Aseptic Pouch Market
3.7 Aseptic Plastic Bottle Market
PART II Science and Engineering Aspects of Aseptic Processing and Packaging Technologies
Chapter 4 Processing System and Thermal Process Design
4.1 Introduction
4.2 Aseptic Processing Establishment
4.2.1 Considerations for Process Calculations
4.2.2 HACCP and Documentation of Control Points
4.3 Aseptic Processing Equipment
4.3.1 Mixing and Cooking Vessel
4.3.2 Pumps
4.3.3 Heat Exchangers
4.3.3.1 Steam Injection or Infusion Heaters
4.3.3.2 Plate Heat Exchangers
4.3.3.3 Tubular Heat Exchangers
4.3.3.4 Scraped Surface Heat Exchangers
4.3.3.5 Ohmic Heating
4.3.3.6 Microwave Heating
4.3.4 Regeneration
4.3.5 Continuous Holding Tubes
4.3.6 Controls
4.3.7 Sterile Surge Tanks, Barrier Seals, and Automatic Valves
4.3.7.1 Sterile Surge Tanks
4.3.7.2 Barrier Seals
4.3.7.3 Valves
4.3.8 Homogenizers
4.3.9 Filters
4.3.9.1 Filter for Gases
4.3.9.2 Filters for Liquids
4.4 Utilities
4.4.1 Formulation Water
4.4.2 System Sterilization Water
4.4.3 Heating/Cooling Water
4.4.4 Refrigerated Water
4.4.5 Steam
4.4.6 Air
4.5 Aseptic Processing Operations
4.5.1 Presterilization of the Processing System
4.5.2 Loss of Sterility
4.5.3 Cleaning
4.5.4 Preventive Maintenance
4.6 Concluding Remarks
Nomenclature
Bibliography
Chapter 5 Thermal Processing Equipment for Heating and Cooling
5.1 Introduction
5.2 Direct Heating
5.2.1 Direct Heating–Steam Injection
5.2.2 Direct Heating–Steam Infusion
5.3 Flash Evaporative Cooling
5.4 Indirect Heat Exchangers
5.4.1 Plate Heat Exchangers
5.4.2 Tubular Heat Exchanger
5.4.2.1 Double-Tube Tubular Heat Exchanger
5.4.2.2 Triple-Tube Heat Exchanger
5.4.2.3 Multitube Heat Exchanger
5.4.2.4 Coil Tube Heat Exchangers
5.4.3 Regeneration
5.4.4 Scraped Surface Heat Exchanger
5.5 Advanced Heating and Cooling Technologies
5.5.1 Advanced Heating Systems
5.5.1.1 Microwave Heating
5.5.1.2 Ohmic Heating
5.5.2 Advances in Cooling Technology
5.6 Holding Tube
5.7 Temperature Indicating Device and Temperature Recording Device
5.8 Automatic Flow Diversion
5.9 Back Pressure Valve
5.10 Preproduction System Sterilization
5.11 Differential Pressure
5.12 Heat Transfer Media
5.12.1 Steam
5.12.2 Hot Water
5.12.3 Cooling Media
5.13 Concluding Remarks
Nomenclature
Latin Letters
Greek Letters
Subscripts
References
Chapter 6 Flow and Residence Time Distribution for Homogeneous and Heterogeneous Fluids
6.1 Basic Considerations of Residence Time and Flow Profile
6.2 Newtonian Fluids
6.3 Non-Newtonian Fluids
6.4 Flows with Particulates
6.4.1 Residence Time Distribution Measurement of Particulate Flows
6.4.2 Simulated Particle Design and Application for Conservative (Worst-Case or Cold-Spot Carrier) Validation
6.4.2.1 Sensors, Data Capture, and Analysis for RTD Calculations
6.5 Concluding Remarks
Nomenclature
Latin Letters
Greek Letters
Subscripts
References
Chapter 7 Thermal Process and Optimization of Aseptic Processes Containing Solid Particulates
7.1 Introduction
7.2 Optimization of Thermal Processes
7.2.1 Thermal Process of Homogeneous Aseptic Products
7.2.2 Quality of Aseptic Products
7.2.3 The HTST Paradigm and Homogeneous Flow Optimization
7.3 Comparison of Conventional Canning and Aseptic Processing and Packaging of Foods
7.3.1 Comparison of Conventional Canning and Aseptic Processing and Packaging of Foods
7.3.2 Some Advantages of Aseptic Processing and Packaging of Foods
7.3.2.1 Nutritional Quality
7.3.2.2 Sensory Quality
7.3.2.3 Sustainability in Storage and Distribution
7.3.2.4 Package Convenience and Microwaveability
7.3.3 Comparison of Processing Methods
7.3.3.1 Pasteurization
7.3.3.2 Ultra-Pasteurization
7.3.3.3 Conventional Canning
7.3.3.4 Refrigerated Aseptic Products
7.3.3.5 Comparison of Continuous Processing Methods Based on Optimization Hierarchy
7.4 Aseptic Process Calculations for Particulate Flows
7.4.1 Calculating Cumulative Thermal Process in Fluids and Particulates
7.4.2 Thermal Treatments for Heterogeneous Products
7.5 Aseptic Quality Optimization
7.5.1 Ingredients
7.5.2 Batching
7.5.3 Heating
7.5.4 Holding Tube
7.5.5 Cooling
7.5.6 Aseptic Storage
7.5.7 Minimizing Shear Damage
7.6 Aseptic Cost Optimization
7.6.1 Ingredient Sourcing
7.6.2 Factorywide Optimization
7.6.3 Optimal Control Strategies
7.6.4 Run-Length Extension
7.7 Future Trends
Nomenclature
References
Chapter 8 Aseptic Filling and Packaging for Retail Products and Food Service
8.1 Introduction
8.2 Aseptic Packaging
8.2.1 Packaging Material
8.2.2 Retail Packaging
8.2.3 Packaging for Retail Food Service
8.2.4 Tamper Proof
8.3 Sterilizing Mechanisms
8.3.1 Heat
8.3.1.1 Wet Heat
8.3.1.2 Dry Heat
8.3.1.3 Heat Extrusion Process
8.3.2 Chemical
8.3.3 Radiation
8.3.3.1 Ultraviolet Radiation
8.3.3.2 Infrared Radiation
8.3.3.3 Pulsed Light
8.3.3.4 Cold Plasma
8.3.4 Irradiation
8.4 Filler Types
8.4.1 Retail Fillers
8.4.1.1 Aseptic Paperboard
8.4.1.2 Aseptic Plastic Cup
8.4.1.3 Bottle Packaging
8.4.1.4 Pouch Packaging
8.4.2 Aseptic Filler for Food Service
8.5 Packaging Integrity Test
8.6 Regulations for Packaging
8.7 Smart Packaging for Aseptic Products
8.8 Sustainability in Aseptic Packaging
References
Chapter 9 Aseptic Packaging Materials and Sterilants
9.1 Product Requirements
9.2 Materials
9.2.1 Non-Barrier Sheeting
9.2.2 Barrier Sheeting
9.3 Sterilizing Agents
9.3.1 Heat
9.3.2 Hot Water
9.3.3 Neutral Aseptic System (NAS
9.3.4 Chemical Sterilants
9.3.5 Radiation
9.4 Packaging Systems
9.4.1 Dole Aseptic Canning
9.4.2 Preformed Thermoformed Containers
9.4.3 Form–Fill–Seal
9.5 Environmental Considerations
Chapter 10 Aseptic Bulk Packaging
10.1 Aseptic Bag-In-Box
10.2 Aseptic Bulk Container
10.3 Aseptic Bulk Storage
10.4 Aseptic Ocean Liner Transportation and Storage
Chapter 11 Design of Facility, Infrastructure, and Utilities
11.1 Basic Considerations of Hygienic Design
11.2 Plant Design and Site Selection
11.2.1 Exterior Considerations
11.2.1.1 Landscaping
11.2.1.2 Exterior Walls
11.2.1.3 Roof
11.2.1.4 Loading Docks
11.2.1.5 Entry Points
11.2.2 Interior
11.2.2.1 Floors
11.2.2.2 Walls
11.2.2.3 Ceiling
11.2.2.4 Drains
11.2.2.5 Equipment Anchoring
11.2.2.6 Personnel Facilities: Locker Rooms and Bathrooms
11.2.3 Equipment Design
11.2.3.1 Materials of Construction
11.2.3.2 Hygienic Design Standards
11.3 Zoning and Flow of Materials and Personnel
11.4 Air-Handling
11.5 Concluding Remarks
References
Chapter 12 Cleaning and Sanitization for Aseptic Processing Operations
12.1 Introduction
12.2 Equipment Preparation and Set Up (EPSU
12.3 Principles of Sanitation
12.3.1 Principles of Sanitation
12.3.2 Personal Hygiene
12.4 CIP (Clean-In-Place
12.4.1 Flow (Scrubbing or Mechanical Force to Remove the Soil) for UHT Systems
12.4.2 Chemical Concentration
12.4.2.1 UHT Processor
12.4.2.2 Sterile Tank
12.4.2.3 Fillers
12.4.3 Time
12.4.4 Temperature for Cleaning UHT Systems
12.4.5 For Sterile Tanks
12.4.6 For Fillers
12.4.6.1 For ESL Fillers
12.4.7 Pulsing of Valves
12.4.8 Ingredients
12.5 Clean-Out-of-Place (COP
12.6 SIP (Sterilization-In-Place
12.7 Aseptic Intermediate Clean (AIC
12.7.1 Concentration of Chemical
12.7.2 Sterile Tanks
12.7.3 Fillers
12.8 Validation and Verification
12.8.1 Validation
12.8.2 Verification
12.9 Passivation
12.9.1 Passivation Process
12.9.1.1 Some Preliminary Considerations
12.9.1.2 Passivation Process
12.9.1.3 Cleaning and Passivation
12.10 Maintenance
12.10.1 Preventive Maintenance
12.10.2 Breakdown Maintenance
12.11 Change Control Management Program (CCM-P
12.11.1 Program Change
12.11.2 Ingredient Change
12.11.3 Procedure Change
12.11.4 Chemical Change
12.12 Environmental Cleaning
12.12.1 Environmental Monitoring
12.12.2 Air Quality
12.12.3 Zoning and Segregation
12.12.4 Other Items
12.13 Summary
12.14 Definitions
12.15 Acronyms
References
Part III Risk-Based Analyses for Attaining “Validated State” for Production of Commercially Sterile Shelf-Stable Products and Guidance for Quality Assurance, Microbiological Food Safety, and Regulatory Compliance
Chapter 13 Microbiology of Aseptically Processed and Packaged Products
13.1 Introduction
13.2 Microbiological Risks Associated with Aseptically Processed Food
13.2.1 Food Safety Risks
13.2.1.1 Spore-Forming Bacterial Pathogens
13.2.1.2 Non-Spore-Forming Bacterial Pathogens
13.2.2 Spoilage Risks
13.2.2.1 Spore-Forming Spoilage Bacteria
13.2.2.2 Non-Spore-Forming Spoilage Bacteria
13.2.2.3 Spoilage Fungi
13.3 Mitigation of the Microbiological Risks Associated with Aseptically Processed Foods
13.3.1 Thermal Treatment
13.3.1.1 Kinetics of Microbial Destruction
13.3.1.2 Industry Standard Thermal Treatments (F-Value Concept
13.3.1.3 Designing a Thermal Treatment
13.3.2 Chemical Sterilants
13.4 Causes of Microbiological Failure in Aseptic Processing and Packaging
13.4.1 Hermetic Seal Failures
13.4.2 Failure Caused by Poor Valve Design or Malfunction
13.4.3 Failure Caused by Poor Design or Inappropriate SIP/CIP Practices for Product Lines
13.4.4 Failure of Sterile Air Overpressure or Unidirectional Sterile Airflow to Protect Filler
13.4.5 Failure Due to Plugged Sterilization Nozzles in Aseptic Filler
13.4.6 Failures Caused by the Presence of Highly Heat-Resistant Microorganisms
13.4.7 Failure Due to Poor Hydration of Critical Ingredients
13.4.8 Other Potential Causes of Microbiological Failures and General Observations
13.5 Summary
References
Chapter 14 Risk-Based Analyses and Methodologies
14.1 Introduction and Background
14.2 Risk-Based Approach
14.2.1 Why Do We Need Standardization
14.2.1.1 Why Do We Need This While It Is Not a Regulatory Requirement in Some Counties/Regions
14.2.2 What Is The Risk
14.2.3 Why Do We Need Risk Analyses of the Aseptic Systems
14.2.4 Risk-Averse Culture Development for Food Systems Should be the Focus of Company-Wide Mission and Vision
14.3 What Should be the Approach to Mitigate Risks
14.3.1 Determination of Food Safety Objectives (FSO) as Part of the Risk Management
14.3.1.1 What Is The PC and How Do We Calculate the Required Log Reduction
14.3.1.2 Log Reduction Calculation
14.4 Systematic Approach is the Key
14.4.1 Operational Readiness and Risk Management
14.5 Failure Mode and Effect Analysis
14.6 Additional Risk Analysis Methodologies
14.6.1 Statistical Methodologies for the Production Data Analyses and Better Decision-Making
14.6.2 Preliminary Hazard Analysis (PHA
14.6.3 Hazard Operability Analysis (HAZOP
14.6.4 Hazard Analysis and Critical Control Point (HACCP
14.6.5 Failure Mode Effects and Criticality Analysis
14.6.6 Fault Tree Analysis (FTA
14.7 Summary
Case Studies
Glossary
References
Chapter 15 Establishing “Validated State” of Aseptic Processing and Packaging Systems
15.1 Introduction
15.2 Validation Master Plan (VMP
15.2.1 Microbiological Validation Plan
15.2.2 Acceptance Criteria
15.2.2.1 Hydration of Dry Ingredients
15.2.2.2 Effectiveness of Particle Distribution
15.2.2.3 Batching Time and Temperature
15.2.2.4 Aseptic Filler Operations
15.2.2.5 Aseptic Processing Operations
15.3 Aseptic System Specifications
15.3.1 Process Schematic
15.3.2 P&ID Schematic
15.3.3 Design Review
15.3.4 Sterilization, Operation, Clean-in-Place, and Maintenance
15.4 Factory Acceptance Test
15.5 Qualification and Commissioning
15.5.1 Installation Qualification (IQ
15.5.2 Operational Qualification
15.5.2.1 Controls Validation
15.5.2.2 CIP Validation
15.5.3 Performance Qualification
15.6 Steps toward “Validated State” of the Aseptic System
15.6.1 Commercial Sterility and System Operation
15.6.2 Selection of Surrogate Organism
15.6.3 UHT Validation
15.6.4 Aseptic Tank Validation
15.6.5 Pre-Production Sterilization of Aseptic Filler
15.6.6 Validation of Aseptic Packaging Material Sterilization
15.6.7 Conveyor Chain Sterilization Test
15.6.8 Maintenance of Aseptic Zone Sterility
15.6.9 Commercial Sterility Test
15.7 Management of Change (MOC) Program
15.7.1 Structure of the MOC Program
15.7.2 Structure of the Committee of MOC
15.7.3 Impact Assessment of a Change
15.7.4 Change Request Process
15.7.5 Change and Urgency Classification
15.7.5.1 Types of Change
15.7.5.2 Level of Urgency
15.7.6 Implementation Plan, Final Disposition, and Closeout
15.7.7 Conclusion and Recommendations
15.8 Regulatory Requirements, Filing, and Standards
15.8.1 Regulations for Aseptic Systems
15.8.2 Regulatory Filing of Aseptic Lines and Products
15.8.3 Standards for Aseptic Equipment
15.9 Summary and Recommendations
15.10 Frequently Asked Questions
Glossary
References
Chapter 16 Quality and Food Safety Management System (QFSMS) for Aseptic and ESL Manufacturing Companies
16.1 Introduction
16.1.1 Concepts
16.1.2 Quality Control (QC
16.1.3 Quality Assurance
16.2 Quality Assurance for Aseptically Processed and Packaged Foods
16.2.1 Quality and Safety by Design
16.2.2 Quality and Safety Risk Management
16.2.3 Corrective and Preventive Action (CAPA
16.2.3.1 Triggers for CAPA
16.2.4 Change Control
16.2.4.1 Need for Change
16.2.4.2 Leadership Support
16.2.4.3 Expert Advice
16.2.4.4 Executing Change Control
16.2.4.5 Monitoring and Verification
16.2.5 Process Authority Roles in the Food Industry
16.2.5.1 Thermal Process Review
16.2.6 External Certification Schemes (GFSI—BRC, SQF, FSSC2200
16.3 The Quality Management Systems Model
16.3.1 Preprocess Assurance
16.3.2 Raw Materials
16.3.3 In-Process Assurance
16.3.4 Postprocess Assurance
16.3.5 Incubated Product Evaluation
16.3.6 Shelf-Life Determination and Stability of Aseptic and ESL Products
16.3.6.1 Storage Protocol
16.3.6.2 Sensory Analysis
16.3.7 Microbiological Testing for Sterility and Sample Size Consideration
16.3.8 Distribution, Handling, and Storage
16.3.9 ASTM Drop Test
16.3.10 Cumulative Assurance and Product Release
16.4 System Requirements for Prerequisite Programs
16.4.1 Facilities and Equipment
16.4.1.1 Grounds and Environment
16.4.1.2 Facility Layout
16.4.1.3 Production Equipment
16.4.1.4 Thermal Processing Operations
16.4.1.5 Aseptic Filling and Packaging Operations
16.4.2 Utilities
16.4.3 Inline Inspection Requirements
16.4.4 Internal Assessments and Auditing
16.4.5 Human Resources and Personnel Development
16.4.5.1 Management Responsibility
16.4.5.2 Plan Creation
16.4.5.3 Implementation
16.4.5.4 Review
16.4.5.5 Sustainability
16.4.5.6 Summary
16.5 The Food Safety Management Systems Models
16.5.1 Hazard Analysis Critical Control Point (HACCP) Program
16.5.1.1 Principles of HACCP
16.5.1.2 Categories of Hazards
16.5.2 Hazard Analysis and Risk-Based Preventive Control
16.5.2.1 Supporting Programs for Food Safety Management
16.5.2.2 Process Controls
16.5.2.3 Current Good Manufacturing Practices
16.5.2.4 Allergen Program
16.5.2.5 Sanitation Program
16.5.2.6 CIP System Validation
16.5.2.7 Aseptic Intermediate Cleanings (AIC
16.5.2.8 Recall
16.5.2.9 Consumer Complaints
16.5.2.10 Supply Chain
16.6 Conclusions and Final Recommendations
Glossary
References
Part IV Frontiers and R&D Opportunities and Challenges
Chapter 17 Computational and Numerical Models and Simulations for Aseptic Processing
17.1 Introduction
17.2 Computational Fluid Dynamics and Heat Transfer Modeling: General
17.2.1 Turbulent Flow Modeling
17.2.2 Non-Newtonian Flow Behavior
17.2.3 CFD Heat Transfer Models in Aseptic Processing
17.3 Examples
17.3.1 Example 1: Conventional Tube-in-Tube Cooling
17.3.1.1 Comparison of Cooling Between Annular and Inner Tube Product Flow for Counter-Current and Co-Current Heat Exchangers
17.3.1.2 Comparison of the Fastest-Moving and the Least-Cooled Fluid Particles
17.3.2 Example 2: Continuous-Flow Microwave Heating—First Generation
17.3.3 Example 3: Continuous-Flow Microwave Heating—Second Generation
17.3.4 Example 4: Continuous-Flow Heating of Products Containing Particles
17.3.5 Example 5: Using Spreadsheet-Based Models for Evaluating Thermal Processes
17.4 Conclusion
List of Symbols
References
Chapter 18 Frontiers and Research and Development: Challenges and Opportunities
18.1 Introduction
18.2 Research and Development Needs and Challenges
18.2.1 Raw Product
18.2.1.1 Raw Food Quality
18.2.1.2 Thermization
18.2.1.3 Enzyme Blockers and Biotechnology
18.2.1.4 Economic Spoilage and Control
18.2.2 Processing
18.2.2.1 12D “Bot Cook” for Milk
18.2.2.2 Lethality Credit for Come-Up Time
18.2.2.3 Control of Hold Time and Temperature
18.2.2.4 Heat Exchangers and Product Quality
18.2.2.5 Holding Tubes
18.2.2.6 Cooling Cycle and Leak Detection
18.2.2.7 Surge Tank
18.2.2.8 Aseptic Processing of Low-Acid Particulate Foods
18.2.2.9 Ohmic Heating
18.2.2.10 Microwave Heating
18.2.2.11 Other Non-Thermal Processes
18.2.2.12 Additive and Synergistic Processes
18.2.3 Aseptic Filling and Packaging
18.2.3.1 Line Speed
18.2.3.2 At-Line and Online Measurements
18.2.3.3 Packaging Issues
18.2.3.4 Bulk Packaging (Chapter 10
18.2.3.5 Pulsed Light Technology
18.2.3.6 Seal Integrity
18.2.3.7 Aseptic Filler or Sterile Work Zone Integrity and Validation
18.2.3.8 Computational and Numerical Models and Simulations
18.2.3.9 Cleanup and Extended Run
18.2.3.10 Defect Rate or Sterility Assurance Level (SAL
18.2.4 Finished Product and Package
18.2.4.1 Flavor Problems
18.2.4.2 Gelation and Other Physical Defects
18.2.4.3 Rapid Microbiological Methods
18.2.4.4 Consumer Education
18.2.4.5 “Aseptic“ versus Quality Fresh
18.2.4.6 Product Development
18.2.5 Process Controls and Electronic Records
18.2.5.1 21 CFR Part 11
18.3 Management and Administrative Challenges and Opportunities
18.3.1 Capital Cost
18.3.2 Complexity
18.3.3 Reliability
18.3.4 Repair and Maintenance
18.3.5 Education and Continual Learning, and Funding for Research
18.4 Future
18.5 Summary
References
Part V Appendices
Appendix 1: United States History & Evolution
Appendix 2: Dr. William McKinley Martin—Father of Aseptic Canning
Appendix 3: Aseptic Filler Profiles
Appendix 4: Aseptic Contract Manufacturers in the United States
Appendix 5: Examples of Typical Thermal Process Design for Aseptically Processed Fluids and Purees
Appendix 6: Process Design and Microbial Validation of a Product with Large Particulates
Appendix 7: Process Design and Microbial Validation of a Product with Large Particulates of Multiple Types
Appendix 8: Thermal Processing Methods
Index