Pharmaceutical Packaging Handbook  book cover
1st Edition

Pharmaceutical Packaging Handbook

ISBN 9781587161513
Published March 24, 2009 by CRC Press
608 Pages

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USD $210.00

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Book 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.


  • 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.

Table of Contents


Introduction to the Pharmaceutical Industry: An Overview


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



Pharmaceutical Dosage Forms and Their Packaging




Chemical Change

Thermal Protection

Chemical Reactions

Moisture Protection—Protecting the API from


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


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





Further Reading


Vaccines and Biologically Produced Pharmaceuticals


Biologic Products

Biologic Drugs


Types of Vaccines


Further Reading


Medical Foods


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


Heat Exchange/Heat Transfer


Aseptic Surge Tanks

Processing Authority

The U.S. FDA/CFSAN Grade A Pasteurized Milk


USDA Requirements

Sterilization Technologies under Development

Future Trends

Further Reading


The Regulatory Environment


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


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


Further Reading


Pharmaceutical Packaging Materials


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


Can Coatings for Tinplate and Aluminum Cans


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


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


Ethylene Vinyl Alcohol

Polyvinyl Alcohol


Catalyst Background for Ethylene and Propylene Polymers

Polyvinyl Chloride

Polyvinylidene Chloride Copolymers



Other Styrene-Modified Copolymers

Polyamides (Nylon)


Polyethylene Terephthalate

Amorphous PET

Crystallized PET

PET Films

Glycol-Modified Polyester

Polyethylene Naphthalate



Acrylonitrile Polymers

Rubbers and Elastomers


Further Reading


Medical Device Packaging


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


Container Fabrication


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


Form, Fill, and Seal Bottles

Plastic Tubes

Laminated Tubes


Further Reading


Sterilization Technology


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



Container Closure Systems: Completing All Types of Filled

Pharmaceutical Containers


Closure Functions



Complete and Positive Sealing

Access (The Ability to Open and Close a Package Repeatedly and Safely)

Consumer Communication


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


Tamper-Evident Packaging Closures

Ease of Opening

Capsule Problems

Heat Sealing

Peelable Seals



Labels and Labeling


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 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


Issues Facing Modern Drug Packaging


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


Other Biodegradable Polymers

Naturally Occurring Biodegradable Polymers

Other Pharmaceutical Packaging Issues


Glossary of Terms



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