Pharmaceutical Packaging
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- Ilene Freeman
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1 Pharmaceutical Packaging Section I: Introduction A. Pharmaceuticals defined B. Pharmaceutical packaging defined C. Study organization D. Methodology E. Geographic regions F. Conventions Section II: Technology A. Technology priorities 1 1. Drug safety and efficacy 2. Drug sensitivity 3. Drug delivery method 4. Regulations drug safety and efficacy 5. Packaging cost 6. Environment and health 7. Packaging requirements B. Devices vs. packages definition 1. Inhalers 2. Pen injection systems 3. Auto-injectors 4. Wearable devices C. Primary packaging 1. Ampules 2. Blister packs 3. Bottles 4. Canisters 5. Cartridges 6. Intravenous (IV) bags 7. Mini-jars 8. Pouches 9. Pre-fillable syringes Tubes Vials
2 Closures Innerseals D. Secondary packaging 1. Blister cards and wallets 2. Folding cartons 3. Trays 4. Other 5. Labels 6. Shrink bands E. Child-resistant packaging 1. Multi-dose packaging 2. Unit-dose packaging 3. Additional child-resistant technologies F. Compliance packaging 1. Calender blister pack 2. Dose indicators 3. Electronic compliance monitoring (ECM) 4. ECM closure 5. ECM blister pack 6. Wallet 7. Summary G. Tamper-evident packaging 1. Inherently tamper-evident packages 2. Not inherently tamper evident 3. Pre-filled syringes H. Unit-dose packaging I. Anti-counterfeit packaging 1. Existing solutions 2. Serialization J. Labeling K. Identification and tracking 1. Barcodes 2. Radio frequency identification (RFID) 3. Near field communications L. Active packaging M. Packaging processes for sterile drugs 1. Traditional aseptic packaging 2. Aseptic packaging with barrier isolation technology 3. Terminal sterilization (in-package sterilization) N. Packaging processes for non-sterile drugs O. Pharmaceutical packaging materials
3 1. Polymers 2. Glass 3. Aluminum foil 4. Paper 5. Paperboard 6. Other P. Pharmaceutical packaging structures 1. Blister pack structures 2. Bottles, vials, ampules, cartridges, and mini-jars 3. Pouch structures 4. Pre-filled syringes 5. IV bags 6. Tube structures 7. Secondary packaging 8. Other structures Q. Pharmaceutical packaging equipment technology 1. Filling equipment 2. Filling equipment suppliers Section III: Market Trends and Projections A. Pharmaceutical industry drivers and trends 1. Government policies6 2. Macro environment 3. New drugs 4. New drug delivery techniques 5. Biologics 6. Generic drugs 7. Delivery devices 8. New drug production techniques B. Pharmaceutical packaging industry drivers and trends 1. Underlying product trends 2. Regulatory environment 3. Government healthcare programs 4. Product differentiation 5. Drug safety 6. Conversions from prescription to OTC 7. Alternative drug delivery methods 8. Environmental 9. Drug protection requirements C. Global primary packaging volume by delivery method
4 1. Cutaneous 2. Inhaled 3. Nasal 4. Ocular 5. Oral delivery 6. Parenteral 7. Transdermal 8. Other D. Global primary packaging volume by package type 1. Ampules 2. Blister packs 3. Bottles 4. Can aerosol 5. Canisters 6. Cartridges 7. Inhaler dry powder 8. IV bags 9. Mini-jars Pouches Pre-fillable syringes Tubes Vials Closures Innerseals E. Global primary packaging value segmented by package type F. Asia primary packaging volume by package type G. China primary packaging volume by package type H. Europe primary packaging volume by package type I. Japan primary packaging volume by package type J. North America primary packaging volume by package type K. ROW primary packaging volume by package type L. Global primary packaging volume by geographic region 1. Asia 2. China 3. Europe 4. Japan 5. North America 6. Rest of World (ROW) M. Global primary packaging value by geographic region N. Global secondary packaging volume by package type 1. Blister cards and wallets
5 2. Folding cartons 3. Trays 4. Other 5. Labels 6. Shrink bands O. Global secondary packaging value by package type P. Primary packaging volume segmented by regulatory status 1. Over-the-counter pharmaceuticals 2. Prescription 3. Projection Q. Primary packaging volume by drug production process 1. Chemical 2. Biological 3. Projection R. Primary packaging volume by distribution channel 1. Institutional 2. Retail 3. Projection S. Primary packaging volume segmented by compliance features 1. Compliance T. Primary packaging volume segmented by anticounterfeiting 1. Anti-counterfeit U. Primary packaging volume by child resistance 1. Child resistance V. Primary packaging volume by tamper evidence 1. Tamper evidence W. Primary packaging volume segmented by material type 1. Primary packaging 2. Blister packs 3. Tubes 4. Pouches and strip packs 5. Secondary packaging Section IV: Packaging Producers
6 Section V: Equipment Suppliers Section VI: Glossary List of Tables 41 List of Figures 43
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