Pharmaceutical Packaging Handbook: 1st Edition (Hardback) book cover

Pharmaceutical Packaging Handbook

1st Edition

By Edward Bauer

CRC Press

608 pages

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Hardback: 9781587161513
pub: 2009-03-24
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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.

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General