Packaging of Pharmaceuticals and Healthcare Products

Transcription

1 Packaging of Pharmaceuticals and Healthcare Products H. LOCKHART Professor, School of Packaging Michigan State University Associate Director Center for Food Pharmaceutical Research Member of Packaging Sub-Committee Committee of Revision U.S. Pharmacopeial Convention and F.A. PAINE Adjunct Professor School of Packaging Michigan State University Consultant Packaging Technology & Management with invited contributions from M.I. ROBERTSON, R.R EVANS and J. GARBETT BLACKIE ACADEMIC & PROFESSIONAL An Imprint of Chapman & Hall London Glasgow Weinheim New York Tokyo Melbourne Madras

2 Contents 1 Introduction to the packaging of Pharmaceuticals and healthcare products 1 Introduction Definition 1 Types of product 2 Ethical medicines 2 Proprietary medicines 4 Other classifications 4 Drug development and design 6 The design process 7 Newer drug delivery systems i() Inhalation therapies '2 References ' 2 2 Spoilage mechanisms 13 Spoilage agents ' The effects of moisture '3 The effects of light and oxygen '5 The effect of heat 16 Other factors IX Mechanical hazards of transport '8 Climatic hazards of distribution -" Biological hazards of distribution 21 Good distribution practice (GDP) Other hazards References 3 Packaging requirements of Pharmaceuticals 25 The origin of drugs Drugs of vegetable and animal origin 25 Synthetic drugs 26 Materials of mineral origin -" Solid preparations - Moisture protection of solid oral preparations 2S Abrasion of solid oral preparations Selection of containers Unit dose packaging Semi-solid (UK) or semi-liquid/viscous (USA) preparations -V Packages for semi-solid preparations * Liquid pharmaceutical preparations - ^ Aqueous oral preparations Aqueous non-oral preparations - "

3 viii CONTENTS Non-aqueous liquids References 4 Developing packaging for medical preparations 42 Introduction T" The packaging decision making process 42 Materials and structure of the package ^3 Sterilisation of materials 43 Package structure ^2 Packaging line engineerin g " Line efficiency " Labelling, text and graphics requirements " Legislative requirements for the packaging of medical preparations 58 Statutory requirements ^8 General manufacturing considerations 62 The packaging specification 62 References 63 APPENDIX 64 Trouble-shooting on-line 64 Introduction: Limitations of the human eye/brain system in high-speed inspection 64 Practical applications 66 Summary 67 5 Licensing considerations regarding the immediate packaging of Pharmaceuticals for human use 68 Introduction 68 Sources of official guidance 68 Licence applications 69 Influence of pharmacopoeias 70 Plastic containers 71 Rubber components of the container 72 The application dossier 73 Container-brief description (Part II. A.2) 73 Development pharmaceutics (Part II. A.4) 73 Packaging material (PartU.C.3) 74 Stability tests on the finished product (Part II.F.2) 75 Master files 76 Medicinal formulation/packaging compatibility 78 Stresses from manufacturing procedures 78 Toxicological investigations 79 Prior use 80 Environmental issues - implications for packaging 80 Labelling 82 Variations 84 Medical devices 87 Problem solving 88 Pre-fillcd syringes 88 Dry powder inhalers 89 Form-fill-seal technique 89 Other plastic packaging/medicinal formulation interactions 90 Glass packaging/medicinal formulation interaction 91

4 CONTENTS IX Closures 91 Metered-dose inhalers 92 Topical metered dosing 92 Pumps for nebulisers 92 Transdermal patches 93 Printing inks and adhesives 93 Two-compartment syringes 93 Two-compartment syringe 94 Moisture ingress 94 References 95 6 Primary and intermediate packages 98 Introduction 98 Major packaging types used 98 ' Primary packaging 99 Glass 99 Plastic containers 101 Use of plastics in pharmaceutical packaging 108 Methods of producing plastic forms 108 Closures for glass and plastic containers 120 '" The general requirements for a good seal 121 v Secondary functions of closures 125 Metal and plastic collapsible tubes 126 Methods of production 1 28 Types of collapsible tube 130 Sealing tubes '31 Types of closure and methods of closing 131 Intermediate packages 132 Common carton styles 133 Folding boxboard cartons '35 7 Quality Assurance for packaging in the pharmaceutical industry 138 Introduction '38 Quality assurance - the component specifications 139 Quality assurance - the QC test specification ' 41 Conformance testing ' "*- Sampling l4 7 Supplier audits I4!S Bibliography 1M) 8 Child-resistant packaging ^1 Introduction Historical background Testing procedures Definitions V Some typical styles of CR packaging ;/ References? * Appendix 1 Extracts from European Protocol pren862 '-M Appendix 2 Revision of US Protocol 17()

5 X CONTENTS 9 Tamper-evident packaging 172 Definition History of tamper-evident packaging 173 The Tylenol case 175 Open or closed retail systems 177 Is tampering a societal problem? 179 Performance standards 181 Conclusions 182 Bibliography 183 Appendix Extracts from the FDA Compliance Policy Guides Packaging of healthcare products 188 Introduction 188 Definition of a medical device 189 Package types 190 Pouches 190 Vented bags 193 Preformed tray/lid packages 193 Thermoform/fill/seal (blister) packages 193 Sterilisation 194 Packaging materials 197 Closure 203 Opening healthcare packaging 203 Summary 204 Further reading 204 Index 206