Table of Contents

1 Introduction to the packaging of pharmaceuticals and healthcare products.- Definition.- Types of product.- Ethical medicines.- Proprietary medicines.- Other classifications.- Drug development and design.- The design process.- Newer drug delivery systems.- Inhalation therapies.- References.- 2 Spoilage mechanisms.- Spoilage agents.- The effects of moisture.- The effects of light and oxygen.- The effect of heat.- Other factors.- Mechanical hazards of transport.- Climatic hazards of distribution.- Biological hazards of distribution.- Good distribution practice (GDP).- Other hazards.- References.- 3 Packaging requirements of pharmaceuticals.- The origin of drugs.- Drugs of vegetable and animal origin.- Synthetic drugs.- Materials of mineral origin.- Solid preparations.- Moisture protection of solid oral preparations.- Abrasion of solid oral preparations.- Selection of containers.- Unit dose packaging.- Semi-solid (UK) or semi-liquid/viscous (USA) preparations.- Packages for semi-solid preparations.- Liquid pharmaceutical preparations.- Aqueous oral preparations.- Aqueous non-oral preparations.- Non-aqueous liquids.- References.- 4 Developing packaging for medical preparations.- The packaging decision making process.- Materials and structure of the package.- Sterilisation of materials.- Package structure.- Packaging line engineering.- Line efficiency.- Labelling, text and graphics requirements.- Legislative requirements for the packaging of medical preparations.- Statutory requirements.- General manufacturing considerations.- The packaging specification.- References.- Trouble-shooting on-line.- Introduction: Limitations of the human eye/brain system in high-speed inspection.- Practical applications.- Summary.- 5 Licensing considerations regarding the immediate packaging ofpharmaceuticals for human use.- Sources of official guidance.- Licence applications.- Influence of pharmacopoeias.- Plastic containers.- Rubber components of the container.- The application dossier.- Container — brief description (Part II.A. 2).- Development pharmaceutics (Part II.A.4).- Packaging material (Part II.C.3).- Stability tests on the finished product (Part II.F.2).- Master files.- Medicinal formulation/packaging compatibility.- Stresses from manufacturing procedures.- Toxicological investigations.- Prior use.- Environmental issues — implications for packaging.- Labelling.- Variations.- Medical devices.- Problem solving.- Pre-filled syringes.- Dry powder inhalers.- Form-fill-seal technique.- Other plastic packaging/medicinal formulation interactions.- Glass packaging/medicinal formulation interaction.- Closures.- Metered-dose inhalers.- Topical metered dosing.- Pumps for nebulisers.- Transdermal patches.- Printing inks and adhesives.- Two-compartment syringes.- Two-compartment syringe.- Moisture ingress.- References.- 6 Primary and intermediate packages.- Major packaging types used.- Primary packaging.- Glass.- Plastic containers.- Use of plastics in pharmaceutical packaging.- Methods of producing plastic forms.- Closures for glass and plastic containers.- The general requirements for a good seal.- Secondary functions of closures.- Metal and plastic collapsible tubes.- Methods of production.- Types of collapsible tube.- Sealing tubes.- Types of closure and methods of closing.- Intermediate packages.- Common carton styles.- Folding boxboard cartons.- 7 Quality Assurance for packaging in the pharmaceutical industry.- Quality assurance — the component specifications.- Quality assurance — the QC test specification.- Conformance testing.- Sampling.-Supplier audits.- 8 Child-resistant packaging.- Historical background.- Testing procedures.- Definitions.- Some typical styles of CR packaging.- References.- Appendix 1 Extracts from European Protocol prEN862.- Appendix 2 Revision of US Protocol.- 9 Tamper-evident packaging.- Definition.- History of tamper-evident packaging.- The Tylenol case.- Open or closed retail systems.- Is tampering a societal problem?.- Performance standards.- Conclusions.- Appendix Extracts from the FDA Compliance Policy Guides.- 10 Packaging of healthcare products.- Definition of a medical device.- Package types.- Pouches.- Vented bags.- Preformed tray/lid packages.- Thermoform/fill/seal (blister) packages.- Sterilisation.- Packaging materials.- Closure.- Opening healthcare packaging.- Summary.- Further reading.

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