Manual Pharmaceutical Packaging Handbook

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No notes for slide. Pharmaceutical packaging hand book 1. Informa Healthcare is an Informa business No claim to original U. Government works Printed in the United States of America on acid-free paper 10 9 8 7 6 5 4 3 2 1 International Standard Book Number Hardcover International Standard Book Number Hardcover This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequence of their use.

No part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www. CCC is a not-for-profit organization that provides licenses and registration for a variety of users.

For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Bauer p. Includes bibliographical references and index.

Serialization Process for the Pharmaceutical Packaging Line

ISBN hardcover : alk. Drugs— Packaging—Handbooks, manuals, etc. Drug Packaging. QV Bp ] RS B38 Visit the Informa Web site at www. Preface Pharmaceutical packaging is a subject that rarely comes to mind when thinking of drugs, medical devices, or other divisions of the health care industry. Packaging done well provides protection, sterility, and safety. Health care professionals and patients hardly give it a thought. Packaging done poorly usually means a package that is hard to open. Pharmaceutical products, or more appropriately biopharmaceutical prod-ucts, and health care in developed countries are wonders of the modern world.

Recent trends and future of pharmaceutical packaging technology - Semantic Scholar

Pharmaceutical products and health care in developing countries and remote parts of the world seems like magic. Diseases that were once fatal and chronic conditions that destroyed lives have slowly been conquered by modern medicine. Views of the body, unimaginable for most of the last century with X rays, are now possible with new imaging techniques that let us see the body in exquisite detail.

We have come to expect a steady stream of new technology that cures or vaccinates us from ailments and potentially deadly viruses. We take for granted that new and better diagnostic techniques will improve our ability to understand and fix our bodies. We have grown accustomed to transplants, angioplasty, stents to open clogged arteries, joint replacements, and other devices that fix and repair our parts of our body.

The packaging and protection of these modern wonders of pharmaceutical and medical technology are almost as important as the drugs themselves. Without packaging, drugs and medical devices would never leave a factory or a laboratory.

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Packaging provides containment, protection, and safe delivery of products everywhere health care is needed and makes possible the availability and use of drugs, vaccines and medical devices in hostile environments. It iii 5. Labels and information contained in packaging communicates and explains to doctors, pharmacists, nurses, health care workers, and patients about how to use a product. It warns you of dangers and communicates how and when to take a drug, what is safe, what precautions to take, and what to avoid when undergoing treatment.

This is an amazing set of packaging tasks that few, if any, notice. Packaging is an emerging science and engineering discipline that touches people everywhere. A combination of natural sciences, engineering, materials science, and other social disciplines contribute to the design, development, and delivery of products, not pharmaceuticals alone. It is a high-technology field that we count on everyday to deliver billions of safe, sterile, and easy-to-open packages that touch every part of our lives.

This book was written as an introduction to pharmaceutical packaging. It has been kept simple and accessible to the average reader with some technical training in chemistry, physics, and engineering. It attempts to introduce you to the many things beyond packaging that are part of the drug, dosage, and regulatory environment. It highlights many of the problems a packaging engineer must face when developing a package for a new product. It uses short explanations of drug composition and interaction with the body to help explain how these issues answer many questions about packaging a drug or medical device.

It introduces many issues that are part of the normal compromises and questions surrounding different drugs.

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It tries to highlight regulatory difficulties by explaining some of the concerns and safeguards various regulations introduce into the package, the product, and the process by which it is made. It provides a short introduction to package-manufacturing processes and the many materials used in pharmaceutical packaging. Hopefully, the book will help you understand the role packaging technol-ogy plays in pharmaceutical and medical device design and development.

It tries to introduce you to several basic concepts of packaging. The book highlights concepts in chemistry, polymer science, packaging and other disciplines to help you understand the product, its composition, what the package must do to protect the product. It provides examples on how the product can change depending on its chemistry and the environment the package must withstand prior to delivery to the patient.

It tries to provide you with a practical sense of how the package, the product, and the way it is manufactured all play an important role in producing a safe sterile product. The book attempts to highlight the whats, whys, and hows that go into pharmaceutical packaging, and attempts to do this while explaining the inter-actions between the drug or device and the package. It is an introduction to the many diverse skills and needs of pharmaceutical packaging.

It highlights the diverse and complimentary skills employed by packaging professionals who are great scientific generalists, that is, people who can combine science, engineering, materials, manufacturing, consumer issues, and societal issues like 6. Preface v environmentalism into packaging. All of these factors are part of the input needed to deliver a drug or medical device in a safe and responsible way.

Packaging has become a new stand-alone scientific and engineering discipline within corporations. Regulation of drugs and medical devices by governments around the world is a big part of packaging. Many reading this book will be surprised to discover the FDA and other regulatory agencies around the world are as critical of the packaging and its performance as they are in examining the efficacy of the drug product. One liberty taken while writing this book is the use of the words drug and pharmaceutical as synonyms.

Technically drug refers to the active pharma-ceutical ingredient in a product, and pharmaceutical refers to the finished product. This means that the pharmaceutical is the product being packaged, not the drug. Hopefully, this book will provide some basic insight into an exciting and challenging science that goes unnoticed by so many. Edward J. Bauer 7. Contents Preface. Introduction to the Pharmaceutical Industry: An Overview. Vaccines and Biologically Produced Pharmaceuticals. Medical Foods. Contents ix Formulas for Metabolic or Genetic Disorders.

The Regulatory Environment. Pharmaceutical Packaging Materials. Contents xi Classes of Polymers. Medical Device Packaging. Container Fabrication. Sterilization Technology. Contents xiii Heat Sterilization Techniques. Labels and Labeling. Issues Facing Modern Drug Packaging. Municipal Solid Waste: An Overview. It differs substantially from food packaging and is equally as challenging. It requires the application of a large amount of scientific and engineering expertise to deliver a product for a world market. Its practice focuses on information and knowledge from a wide range of scientific disciplines, including chemistry, engineering, material science, physical testing, sales, marketing, environmental science, and regulatory affairs to name just a few.

This broad general background is needed for the design and development of each and every product produced by the pharmaceutical industry. Packaging is responsible for providing life-saving drugs, medical devices, medical treatments, and new products like medical nutritionals nutraceuticals in every imaginable dosage form to deliver every type of supplement, poultice, liquid, solid, powder, suspension, or drop to people the world over.

It is transparent to an end user when done well and is open to criticism from all quarters when done poorly. Everyone is a packaging expert, and this is particularly true when one evaluates how something designed to help a person hinders his or her ability to use the product. This book will discuss in detail the many forms of pharmaceutical packaging. It will provide an introduction to some of the chemistry of pharmaceutically active molecules and how they must be protected from the environment and from the package itself.

It will touch upon the packaging of nutritional products and supplements that are 1 Packaging for biologic products can involve a slightly different set of requirements, and some of the unique differences and problems for packaging genetically modified biologically produced products are noted. Pharmaceuticals use a wide variety of sterilization techniques that vary significantly from those used for foods.

An introduction to some of these con-cepts will touch upon the multiple sterilization processes and the problems they present to the design of drug and device packaging. Distribution of products is now more global than ever. Mass customization of packaging to permit its use in multiple markets is a topic that needs exposition and discussion.

Environmental issues, including sustainability, will always be a subjective dimension to any packaging design. These topics and many others highlight the breath of knowledge a packaging engineer must master when developing and producing a widely acceptable product. This is a lot of ground for any book to cover. Hopefully it will provide you with a ready reference replete with examples that provide a starting point for design, development, testing, and execution of a new package for any pharmaceutical product.

Pharmaceutical Packaging Handbook

The book also provides an introduction to over-the-counter OTC pack-ages and products. These are the medicines we keep in our homes and many times carry with us to relieve unpleasant symptoms of things we think of as annoyances to everyday life, like the common cold, or for treatment of common conditions, including rashes, cold sores, dry eyes, and other minor problems. It will discuss labeling, and how copy and artwork are prepared for all types of packaging. So many different requirements, so many facets to packaging, so many scientific, cultural, sociological, and environmental needs.

Oh, and by the way, it also has a large regulatory and legal requirement that is outside all of the things mentioned above. Packaging is an emerging science, an emerging engineering discipline, and a success contributor to corporations. Surprisingly it is something that few corporations have singled out as a stand-alone department or organization. For the majority of products produced in the food and pharmaceutical industries it is probably the single largest aggregate purchase made by a company of materials critical to the protection, distribution, and sale of the product.

Hopefully the contents of this text will provide a new appreci-ation of how important and complex pharmaceutical packaging is, not just the traditional expectations of product protection. For most of the 20th century, the pharmaceutical business paralleled developments in synthesis, catalysis, and manufacturing that were outgrowths of the larger chemical business.

Before World War II, advances in chemistry and chemical engineering from Europe, particularly from Germany, drove both the worldwide chemical industry and the smaller pharmaceutical companies. The United States developed its own group of companies that, with only a few notable exceptions, concentrated on the U. The United States and Europe became the two centers of the chemical industry and developed in parallel, as they expanded to meet the growing demand for chemical products in the markets of concentration.

Two examples of European influence on U. Another example of European influence is seen in one of the largest, best-known products in the United States, aspirin, which came from Bayer1, another German company.


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In fact, aspirin was probably the first of what we would today call a blockbuster drug. At the end of World War II, the American chemical industry emerged as the dominant force in the world. The U. The pharmaceutical companies followed the same path of expansion, while beginning to develop the unique chemical, chemical engineering, and manu-facturing knowledge necessary to produce pharmaceutical ingredients and bring these unique products to market. The world war also produced a burst of knowledge about the production and manufacture of biologic products, notably penicillin.

During this period, the United States also began to produce world-class scientific talent necessary to build and sustain the pharmaceutical industry and develop world-class facilities for the development of scientific knowhow in both industry and the universities. The new technology was a combination of biology, chemistry, biochemistry, and new cell modification and manufacturing tech-nologies called biotech.

This breakthrough technology challenged the traditional way of identifying and developing pharmaceutical products. Genentech was the first company to establish an identity in biotech. It was founded by a geneticist, Amgen, located in Thousand Oaks California, followed shortly after and was the first of the new biotech companies to introduce a biologically derived pharmaceutical product.

These two early leaders not only changed the way pharmaceuticals were developed, they also ushered in a new way of developing pharmaceutical products using genetics, molecular biology, and biochemistry that when combined produced a genetic engineering approach to the treatment of disease. They have transformed themselves into biopharmaceutical companies.