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OverviewFull Product DetailsAuthor: Frank A. Paine , H. LockhartPublisher: Chapman and Hall Imprint: Chapman and Hall Edition: 1996 ed. Dimensions: Width: 15.50cm , Height: 1.90cm , Length: 23.50cm Weight: 1.100kg ISBN: 9780751401677ISBN 10: 0751401676 Pages: 211 Publication Date: 31 December 1995 Audience: Professional and scholarly , General/trade , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of Contents1 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.ReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |