Pharmaceutical packaging: child-resistant, easy opening, sustainable
Child safety, and specifically protection from poisoning, is a crucial factor in medicine packaging. In this article, Stephen Wilkins, Chairman of the Child-Safe Packaging Group, discusses the standards that govern child-safe packaging, as well as the importance of ‘ease of opening’ for elderly adults…
All packaging must fulfil a variety of functions, such as protection and communication, but pharmaceutical packaging has additional responsibility in terms of its role. Pharmaceutical manufacture has been subject to very high standards for many years – far longer, for example, than food and drink – and pharma packaging is manufactured to equally high standards.
Whilst ordinary consumer packaging protects and informs, pharma packaging goes further. Yes, it protects – but to a far greater extent. Yes, it informs – but its communication is crucial. A miss-stated quantity can make a medicine at best ineffective and at worst lethal. Medicine packaging must, in many cases, be child resistant yet present no difficulty for its intended users – often elderly adults – to open and use properly. At the same time, and despite derogations, the industry takes a rational and measured approach to sustainability and packaging essential requirements. Indeed, to quote the Proprietary Association of Great Britain (PAGB), the trade body representing the over-the-counter (OTC) sector of the pharmaceutical industry: “All packaging for these products must comply with relevant legislative requirements, including the Packaging and Packaging Waste Directive.”
The PAGB also stipulates that plastic materials used in the packaging or measuring of OTC medicines and plastics used to manufacture self-care medical devices and to pack food supplements are not to be considered in the same category as disposable plastic water bottles, straws and coffee cups. Indeed, the retail sector agrees. Sainsbury’s, which has created a ‘traffic light’ system classifying various polymers as: red = unacceptable, amber = questionable and green = acceptable, has excluded pharmaceutical packaging from its system. Thus, PVC blister trays are acceptable to Sainsbury’s even though PVC, whilst recyclable on its own, will not mix with other polymers and thus is said to contaminate the waste stream. We live in a kinetic environment, however, and research is ongoing at several UK universities into the recovery of materials by microwave pyrolysis; in particular, aluminium from used PVC blister packs.
Child safety, and specifically protection from poisoning, is a crucial factor in medicine packaging. In the early 1970s child-resistant packaging was introduced to the UK and was described by the World Health Organization (WHO) in 2008 as the “best documented cause of the reduction of child poisoning in the developed world.”
Since its introduction, child-resistant packaging has developed and matured to such an extent that it is now an accepted and effective product in the UK, EU, USA, Canada and Australia. It is rapidly gaining acceptance in China, other south-east Asian countries, and India. Child-resistant packaging is not “child proof”; it is “packaging that is difficult for a child younger than 52 months to open, but not difficult for an adult to use properly.” That definition has been taken from ISO 8317:2015, one of the three ISO standards that govern this type of packaging in all countries other than the USA. In the United States, the regulation 16CFR1700.20 defines “special packaging” in a similar way.
ISO 8317:2015 is a testing standard for re-closable, child-resistant packaging for any content. The other two international standards are: ISO 14375:2018, which covers non-reclosable packaging for medicines and ISO 28862:2018, which covers non-reclosable packaging for non-pharmaceutical products. There is a fourth standard, ISO 13127:2012, which covers mechanical test methods for packaging that has been successfully tested for compliance with ISO 8317, but has undergone a minor change.
The first three ISO standards are type testing panel-based standards and are cited in regulation in one form or another in the developed and developing world. These standards work by subjecting packaging to panel tests by both children and adults. The child test uses a panel of children aged 42-51 months. Sequential testing is used so the panel is of indeterminate size, however, a valid statistical inference may be taken with a relatively small sample, the minimum being 30 children. The test is simple but extremely rigorous.
Under observation of an adult researcher, children work in pairs and are given a new, unused pack, which they are asked to open; they have five minutes. The test supervisor then performs a ‘silent demonstration’. She opens the pack without drawing attention to any one action, then says to the children: “Now have another try”. Each failure – in other words, each time a pack is opened – necessitates the testing of a further five samples. An excellent pack will pass the test at trial 30, ie, no failures; a mediocre pack will pass at trial 55-65; and a poor pack will pass or fail at trial 70-200.
Packaging is made child resistant by asking the user to perform either two opposing actions at the same time or two sequential actions. In the former case, examples are push turn two-piece closures or squeeze and turn closures; a child under 52 months simply doesn’t understand the algorithm. The affordance of the pack, the signs it gives as to how it works, is simply beyond the cognisance of a child of that age.
Child-resistant blister packs work in a slightly different way. Children don’t try to push tablets through the lidding foil as the design intends; they try to dig through the foil with their little fingers. Child resistance and adult openability can therefore be achieved by using either a simple or complex multilaminate; simple being a paper label and complex being anything up to seven laminate layers.
Ease of opening for elderly adults
The standards accord the adult test equal importance because the packaging must not be difficult for adults to use properly. This is a straightforward test. A panel of 100 adults (70 percent female) aged 50-70 years test the pack. Each panel member is given up to five minutes to familiarise themselves with the pack and show that they have done so by either opening and reclosing it or opening and extracting one unit, depending on the standard. After familiarisation, the panel members are given a new pack and asked to open it as ‘quickly as they can’. They must do so in one minute.
This is a simple test; for the pack to pass it requires 90 percent of the adult sample to open and reclose or open and extract in one minute. However, despite being simple and effective, these standards remain open to improvement.
In the standards writing community – CEN and ISO – we have done just that. The adult panel age of 50-70 years doesn’t even pretend to represent the population; it is merely a benchmark. It demonstrates that older adults or seniors can open child-resistant packaging, and as a benchmark it is effective. However, with a worldwide population of more than 550 million people aged over 65 – between 13 and 20 percent of the population of each developed country – the industry needed another standard against which to test its products.
As a result, ISO 17480:2015 was developed, titled ‘Packaging. Accessible Design. Ease of Opening’. Amongst other things it contains a test method for elderly adults using a panel of 65-80-year-old people. Unlike the standards covering child-resistant packaging, ISO 17480 is not cited in regulation. Its use is totally voluntary. Organisations that use it do so to improve the accessibility of their packaging for our growing senior population. Obviously, when your brand becomes the favourite or even just favoured by between 13 and 20 percent of the population – the over 65s – you gain a tremendous volume of competitive advantage. Ignore that increasingly powerful and wealthy sector at your peril.
ISO 17480 is not limited to packaging for medicines; it covers any product or pack that does not require an opening tool. As a standard it is not a set of rules, but a collection of concepts from which we create our own rules. In fact, compliance is described as “by agreement between the parties” as well as “by complying with the terms of this international standard”. The standard contains a design checklist as one of seven informative annexes; sections to expand on or explain the concepts in the standard. Most importantly, ISO 17480 considers dexterity and cognition as well as opening strength. Similarly, it considers location and methods as well as force and handling. Finally, it considers reclosing.
When considering what a good design and competitive advantage tool ISO 17480 is, it is worth investigating how products fail the adult openability test. Certainly, if more force or torque than an elderly person can employ is required to open a pack, then it will fail. But dexterity and cognition are vitally important too. If an opening mechanism is counter-intuitive or if it requires manual contortion, then it will fail an adult test.
People don’t like to look stupid – especially the elderly – and if they can’t open a supposedly simple pack then they will certainly feel stupid. As a result, they will not purchase the offending product again. Let us consider the effects.
Failure to open a pack of pharmaceutical products leads to poor or total lack of compliance. Lack of compliance leads to continuation of ill health, selection of antibiotic resistant bacteria and a shortening of a healthy lifestyle: a heavy price to pay for a small volume of cost reduction.
STEPHEN WILKINS was educated at Blackrock College, Dublin and The University of Durham Business School where he obtained a Masters Degree in Business Administration. He is a Chartered Scientist, Chartered Environmentalist and a Fellow of both the Institute of Materials Minerals and Mining and the Royal Society of Arts. He is also a member of the Packaging Federation.
He was appointed chief executive of the Child-Safe Packaging Group upon its formation in 1995 and has driven its activities since then. The Child-Safe Packaging Group has been responsible for the design and development of numerous new child-resistant packaging designs, in both flexible and rigid packs. Stephen Wilkins advises manufacturers on the development of child-resistant packaging, on the need for that packaging and, in more general terms, he advises clients on strategic marketing issues, usually associated with packaging and its semiotics.
In addition, he is a director of Davies Development and Testing Limited, a laboratory, accredited by UKAS, to undertake testing of child-resistant packaging under various European, US and International standards. He also sits on several BSI, CEN and ISO committees concerned with developing standards for packaging; three of which he chairs.
He also acts for clients in the UK in disciplines other than packaging, where he delivers marketing communications consultancy and parliamentary liaison.