Pharmaceutical Packaging Handbook (Hardcover)

Preface Introduction to the Pharmaceutical Industry: An Overview Introduction General Aspects of Drug Packaging Brief History General Business Overview of the Pharmaceutical Industry General Industry Challenges and Trends The Evolution and Structure of the Pharmaceutical Business Therapeutic Areas of Concentration General Worldwide Pharmaceutical Trends Cost and Pricing Trends Generic Products OTC Products Definition of a Drug The Differences between Pharmaceutical and Food Packaging Drug Regulations The Function of Packaging Trends in Pharmaceutical Packaging Current Trends in Packaging Influences Impacting Packaging Summary References Pharmaceutical Dosage Forms and Their Packaging Requirements Introduction Stability Chemical Change Thermal Protection Chemical Reactions Moisture Protection?Protecting the API from Hydrolysis Oxidation?Reactions with Oxygen Light Protection Mathematical Methods and Accelerated Methods for Assessing Shelf Life Purity and Sterility Drug Purity Quality Assurance Drug Sterility Drug Physiology Oral Administration of Drug Products?Gastrointestinal Methods Direct Injection of Drug Products Topical Administration of Drugs, Transdermal Methods Topical Administration Administration of Drugs through Mucus Membranes, Inhalation, and Nasal Administration Rectal Administration of Drugs Dosage Forms of Drugs Solids Liquids Gases Summary Further Reading References Vaccines and Biologically Produced Pharmaceuticals Introduction Biologic Products Biologic Drugs Vaccines Types of Vaccines Summary Further Reading References Medical Foods Introduction History of Medical Foods Regulatory Requirements of Medical Foods Medical Foods Composition and Formulation of Medical Nutritional Products Nutritionally Complete Products Nutritionally Incomplete Products Formulas for Metabolic or Genetic Disorders Oral Rehydration Solutions Enteral Packaging Medical Food Administration to the Patient Tube Feeding Parenteral Nutrition Parenteral Formulations for Intravenous Feeding Infant Formulas Prenatal Nutritional Products Juvenile Nutritional Products Medical Foods: Legislative Overview and Regulations Infant Formula Regulation Manufacture of Infant Formula and Medical Nutritional Products Retort Processing Aseptic Processing Cold Aseptic Sterilization?Aseptic Filtration Aseptic Manufacturing Equipment Aseptic Package Sterilization Mechanical Processes Thermal Processes Irradiation Processes Chemical Processes Combination Processes Aseptic Packaging Systems Fill and Seal Erect, Fill, and Seal Form, Fill, and Seal Thermoform, Fill, and Seal Blow Mold, Fill, and Seal Bulk Storage and Packaging Basic Principles of Thermal Processing Thermobacteriology Heat Exchange/Heat Transfer Deaeration Aseptic Surge Tanks Processing Authority The U.S. FDA/CFSAN Grade A Pasteurized Milk Ordinance USDA Requirements Sterilization Technologies under Development Future Trends Further Reading References The Regulatory Environment Introduction Stages in the Identification and Qualification of a Drug Drug Discovery Preclinical Testing Investigational New Drug Review Clinical Trials Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials FDA Approval Post-Marketing Surveillance and Phase IV Studies The Regulatory Arena The United States Food and Drug Administration A General Overview of the Drug Approval Process The Drug Packaging Approval Process Current Good Manufacturing Practices Validation Electronic Data Submission, Electronic Specifications Systems, Elimination of Paper Records 21 CFR Part 11 Electronic Records Change Control Structured Product Labeling: Enterprise Content Management, Digital Asset Management The United States Pharmacopeia-National Formulary The United States Pharmacopeia Dictionary Consumer Product Safety Commission Summary Further Reading References Pharmaceutical Packaging Materials Introduction Glass Pharmaceutical Packaging Glass Composition Types of Glass Used for Pharmaceutical Packaging USP Type I Glass USP Type II Glass USP Type III Glass USP Designation NP Glass Glass as a Pharmaceutical Packaging Material Metal Pharmaceutical Packaging Tinplate Can Coatings for Tinplate and Aluminum Cans Aluminum Metals as Pharmaceutical Packaging Materials Aerosol Cans Plastic Pharmaceutical Packaging Plastics Overview and Definition Introduction to Plastics A Plastic Primer Polymer Descriptions Classes of Polymers Determinants of a Polymer’s Properties Chemical Attributes of Polymers Chemical Bonding Molecular Shape and Intramolecular Forces Viscoelastic Behavior Physical Properties of Polymers Temperature Dependence on Reaction Rates Plastics as Drug Packaging Materials Density Differences/Consumer Preference for Plastic/Easy Handling Design Freedom Plastic Disadvantages Chemical Inertness/Stress Cracking/Additives/Electrical Properties Common Plastic Pharmaceutical Packaging Materials Polyethylene Polymers High-Density Polyethylene Low-Density Polyethylene Linear Low-Density Polyethylene Polyethylene Restrictions in Drug Packaging Other Ethylene Polymers Ethylene Vinyl Acetate Ethylene Acrylic Acid Ionomers Ethylene Vinyl Alcohol Polyvinyl Alcohol Polypropylene Catalyst Background for Ethylene and Propylene Polymers Polyvinyl Chloride Polyvinylidene Chloride Copolymers Fluoropolymers Polystyrene Other Styrene-Modified Copolymers Polyamides (Nylon) Polyester Polyethylene Terephthalate Amorphous PET Crystallized PET PET Films Glycol-Modified Polyester Polyethylene Naphthalate Polycarbonate Polyurethane Acrylonitrile Polymers Rubbers and Elastomers Summary Further Reading References Medical Device Packaging Introduction Regulation of Medical Devices Medical Device Definitions and Testing Standards 510 (k) Pre-market Notification Pre-market Approval of a Medical Device Good Manufacturing Compliance (CGMP) Establishment Registration Medical Device Reporting Harmonization of Standards for Terminally Sterilized Medical Device Packaging?United States and Europe An Overview of a Package Validation Major Elements of a Package Validation Validation Testing, Process Sampling, and Validation Reporting Sample Size Testing Test Methods Distribution Testing Accelerated Aging ISO Standards References Container Fabrication Introduction Glass Containers Blow Molding of Glass Containers Annealing and Treating?Glass Finishing Tubular Glass Fabrication?USP Type I Glass Metal Containers?Cans Draw?Redraw Cans Draw and Iron Cans Welded Cans?Three-Piece Cans Metal Tubes Plastic Containers Bottles and Vials Thermoforming of Pharmaceutical Containers Blister Packaging Large Thermoformed Packages?Strip, Tray, and Clamshell Packages for Medical Devices Pouches Form, Fill, and Seal Bottles Plastic Tubes Laminated Tubes Summary Further Reading References Sterilization Technology Introduction Overview of Sterilization Requirements Heat Sterilization Techniques Sterilization Using Steam and Pressure (Autoclave) Sterilization by Boiling Dry Heat Other Heat Sterilization Methods Chemical Sterilization EtO Sterilization Other Chemical Sterilants Radiation Sterilization g-Ray Sterilization X-Rays and Electron Beam (E-Beam) Sterilization UV Light Sterile Filtration Regulatory Overview Monitoring Sterilization Processes Mechanical, Chemical, and Biologic Indicators Summary References Container Closure Systems: Completing All Types of Filled Pharmaceutical Containers Introduction Closure Functions Protection Containment Complete and Positive Sealing Access (The Ability to Open and Close a Package Repeatedly and Safely) Consumer Communication Display Metering and Measuring Types of Closures Closures for Metal Cans Bottles and Jars Threaded Closures Friction-Fit Closures Crown Closures Snap-Fit Closures Press-on Vacuum Caps Vial Stoppers Flanged Plug Elastomeric Stoppers Flanged Hollow Plug with Cutouts for Lyophilized Products Flanged Elastomeric Plug with Plastic Overseal Metal Closure with an Elastomeric Disk Elastomeric Closure Performance Tube Closures Specialty Closures Dispensing Closures and Closures with Applicators Fitment Closures Spray and Pump Dispensers Single-Dose Closures Compliance (Adherence) Closure Liners Composition of Closure Liners Linerless Closures Child-Resistant Closures Child-Resistant Testing of Closures?An Overview Design of Child-Resistant Closures Combination Closures Aerosol Closures Non-Reclosable Packages Pouches Tamper-Evident Packaging Closures Ease of Opening Capsule Problems Heat Sealing Peelable Seals Summary References Labels and Labeling Introduction History of Drug Labels Labeling Requirements Prescription Drug Labeling Label Information Drug Facts Labeling?OTC Pharmaceutical Products NDC Number?The National Drug Code Label Construction Types of Labels Label and Package Printing Overview of Bar Code Administration: GS1 Designations Universal Product Code Numbers The Global Trade Item Number Bar Codes GS1 Standards Organization EAN International Article Numbering Association and UCC Two Dimensional Codes (2-D Data Matrix and other Matrix Codes) RSS Codes RSS-14 RSS Limited RSS Expanded Composite Components of the Codes Composite Code A (CC-A) Composite Code B (CC-B) Composite Component C (CC-C) Code Category Overview Narrow-Width Bar Code Symbologies Pulse-Width Modulated Bar Code Multi-Width Modular Codes References Issues Facing Modern Drug Packaging Introduction Compliance or Adherence to Drug Regimens Unit Dose Packaging Anticounterfeiting Packaging Detailed Product Information Transaction Details Environmental Issues Packaging and the Environment United States Recycling Programs Collection Methods for Recycling European Recycling Programs Plastic Packaging and the Environment Recycling Rates for Plastic Packaging U.S. Municipal Solid Waste: An Overview Infectious Waste Biodegradable Plastics Biodegradable Materials Starch-Based Plastics Lactic Acid Polymers Polyesters Other Biodegradable Polymers Naturally Occurring Biodegradable Polymers Other Pharmaceutical Packaging Issues References Glossary of Terms Bibliography Index