When Glass meets Pharma

Contents

Preface

1. The nature of glass

1.1 Structure of glass

1.2 Chemical composition

1.3 Type I and Type III glass

1.4 Production of tubular and molded containers

2. Glass and heat

2.1 Viscosity

2.2 Stress

2.3 Coefficient of thermal expansion (CTE)

2.4 Thermal conductivity

2.5 Thermal shock resistance

2.6 Lyophilization

3. Glass and radiation and gases

3.1 Light transmission

3.2 Light protection

3.3 Gamma radiation

3.4 Permeability

4. Glass and liquids—chemical resistance

4.1 Reactions with acidic solutions

4.2 Reactions with basic solutions

4.3 Reactions with water

4.4 Testing methods for hydrolytic resistance

4.5 pH shift

4.6 Reactions with organic acids

4.7 Extractables and leachables

5. Glass surface reactions

5.1 Surface layer

5.2 Charge of the glass surface

5.3 Water contact angle

5.4 Weathering

5.5 Roughness

5.6 Sulfate surface treatment

5.7 Chemical toughening

5.8 Delamination

5.9 Protein adsorption

6. Glass strength

6.1 Ductile and brittle materials

6.2 Elasticity and plasticity

6.3 Stress and strain

6.4 Stiffness and modulus of elasticity

6.5 Hardness

6.6 Damage to glass

6.7 Crack growth

6.8 Breakage

References

Preface

Talking with pharmaceutical companies and giving technical seminars about glass for pharmaceutical packaging, I was faced by a huge curiosity for this material “glass”. Up to now, glass has always been taken for granted because it has been used for centuries. Therefore, it never really was in the spotlight of interest for pharmaceutical companies. However, with the increase in quality awareness, the development of new packaging materials, and the growing development of biopharmaceuticals, the possible interactions of the drug with the container have increasingly come into focus.

Several good books about glass chemistry, glass physics and its applications are available. On the other side, there are several good books on the market summarizing the various pharmaceutical packaging choices.

In order to close this gap, the book sets out to combine the world of inorganic glass chemistry with the world of organic drug molecules. Therefore, it focuses exclusively on pharmaceutical applications and endeavors to make the complicated chemical and physical fundamentals accessible to everyone, including non-scientists. This book was written especially for manufacturers, suppliers, and personnel working in regulatory affairs in the pharmaceutical industry but should also be of interest to all others who would like to dive into those parts of the glass world that are relevant for pharmaceutical applications. The topics covered in this book arose from the numerous fruitful discussions with staff of pharmaceutical companies over the past years.

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