Pharmaceutical Packaging Handbook

Pharmaceutical Packaging Handbook

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Description

Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods.


Features:












Discusses how packaging is designed and integrated into the product development cycle
Provides an overview of the regulatory environment procedures
Describes the materials used to package pharmaceuticals, including glass, metal, plastics, flexible films, rubber, and elastomers
Examines new hybrids used for packaging
Explores the processing techniques used with the materials to produce pharmaceutical containers
Discusses some of the strengths and weaknesses of the processes used for container fabrication
Explains retort, aseptic, gas, and radiation sterilization of product
Reviews labeling and design for pharmaceuticals, including how labels are produced, materials used, and production techniques









Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.
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Product details

  • Hardback | 608 pages
  • 152.4 x 231.14 x 38.1mm | 612.35g
  • CRC Press Inc
  • Bosa Roca, United States
  • English
  • 1587161516
  • 9781587161513

Table of contents

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
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