Packaging of Pharmaceuticals and Healthcare Products, 1996

As was the case with Charles Ross's Packaging of Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging Users Handbook and the Handbook of Food Packaging are recommended. The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance. Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product when presented for use in hospital or surgery. Even when on sale at the pharmacy the 'appeal' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.

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.