Child-safe and senior-friendly packaging26 April 2013
Child-resistant packaging has been a real success story for the packaging industry over the last 40 years. Stephen Wilkins, chief executive of the Child-Safe Packaging Group, looks at the great strides the sector is taking to improve packaging functionality for children and the elderly alike.
According to the World Health Organization (WHO), in its 2008 report on child injury prevention, "Child-resistant packaging is one of the best-documented successes in preventing the unintentional poisoning of children." WHO went on to quote the numbers, which are impressive: "In England and Wales, unintentional poisoning deaths of children aged under the age of ten years fell steadily from 151 per 100,000 in 1968 to 23 per 100,000 in 2000."
Fortunately, child fatalities from unintentional poisoning are rare; however, for each such tragedy there are tens of thousands of ingestions, many with life-changing consequences; and although the substantial reduction in child ingestions of potentially harmful substances is not solely due to the increasing use of child-resistant packaging, such packaging has played a major role in improving child safety.
Rules and regulations
I would also argue that child-resistant packs have played a major part in the introduction of easier opening for
our aging population. This is a bold assertion; to investigate it, we need to look at the standards - British, European and international - that cover child-resistant packaging.
There are five standards that need to be considered:
- BS EN 14375: 2003: test methods for non-reclosable packs for medicines, using panels of children and adults
- BS EN ISO 8317: 2004: test methods for reclosable packs for any contents, using panels comprised of children and adults
- BS EN 862: 2005: test methods for non-reclosable packs for non-medicines, using panels of children and adults
- BS EN 13127: 2012: mechanical test methods for reclosable packs for any contents
- 16 CFR 1700.20: the American standard covering both reclosable and non-reclosable packs for any contents, using panels of children and adults.
Quite a collection. And in the UK, the regulations are:
- Human Medicines Regulations 2012 SI 2012/1916 for medicines
- European Regulation (EC) 1272/2008, for non-medicines.
The four standards that use panels of children and adults work quite simply as type-testing standards as opposed to quality-management tools. The adult test is necessary because of the important definition of child-resistant packaging, which, according to BS EN 14375: 2003 at section 3.1, is a "package which is difficult for young children to open (or gain access to the contents), but which it is possible for adults to use properly". The key words are "adults to use properly"; and the other standards contain similar definitions.
A testing future
The adult test requires 100 adults to attempt to open and, if applicable, properly reclose the pack. For the pack to pass the test, 90% must succeed in doing so.
Panel members are aged 50-70 and 70% female (50/50 male/female between ages 50 and 59, with the other half between 60 and 70 not necessarily evenly spread). After handling a familiarisation pack, they have one minute to open and reclose the test pack, one that has not been opened before. With a good pack, most panel members open and close it in a matter of seconds.
It is this test that makes nonsense of the quip, often voiced by ill-informed individuals, that child-resistant containers are adult-resistant as well.
The child test is more complex. Children aged between 42 and 51 months, working in pairs, try for five minutes to open the pack. They then witness a silent demonstration by the test supervisor and try again for another five minutes.
For the pack to pass, 85% must fail to open it before the demonstration and 80% must fail to do so after the demonstration. The sample size is variable: up to 200 children. However, sequential testing, a Bayesian tool, is used. This enables a result to be obtained with a much smaller sample. Results are plotted as they occur, creating a curve between two axes (x and y) which, using a preset grid, moves into an acceptance or rejection zone.
In this way, an excellent pack can pass the test with a sample size as small as 30 and, conversely, an extremely poor pack will fail the test with a sample size smaller than ten. Usually, though, a good pack will pass the child test with a sample of 50 children.
The testing environment is strictly controlled. Tests are conducted in the child's school or playgroup, with as many as five pairs working in one room simultaneously, each pair being observed by a skilled researcher. Although observers are permitted, procedures are in place to prevent any distractions or bias.
BS EN ISO 13127: 2012, the mechanical testing standard, was published in February 2013. It is intended to be used in the event of minor changes to a previously panel-tested pack, and is not intended to replace panel testing. It may be used when those minor changes affect only the mechanical functionality of the pack (rather than the interface between the pack and the child); for example, the pack size or shape. This standard is not yet cited in regulation. Its route into regulation will come about through the revision of BS EN ISO 8317, where it will be cited, and this is due later in 2013.
Testing under all these standards must be carried out by suitably skilled and accredited persons and organisations. Testing laboratories must be accredited to full compliance with BS EN ISO/IEC 17025: 2005: general requirements for the competence of testing and calibration laboratories.
All of this works well and over the last 45 years has saved many children from serious injury, and many families from trauma and even tragedy.
I will now, though, consider its effect on elderly people and then look again at the regulations and consider whether they are making the most use of the standards.
The adult test has been part of the child-resistant packaging scenario since the early 1970s and, as the standards have moved through revisions, the upper age limit of the adult sample has increased to its present level of 70. This, though, does not even pretend to mirror the population; it is only a benchmark. However, it true to say that child-resistant packaging has been and remains the only packaging that is mandatorily tested for openability by elderly people. This means that much expertise has been gathered by manufacturers in designing to meet the needs of our aging population.
Research conducted by my colleague Dr Alaster Yoxall at the University of Sheffield showed, among other things, that between the ages of 65 and 75 people lose 50% of their manual strength and dexterity. But this is not the only effect of aging. Older people frequently suffer from poor vision and this impacts on their ability to read labels and opening instructions on packaging. But, most importantly, the onset of old age brings a reduction in confidence that gives rise to irrational fears: fears like the fear of being unable to gain access to medicines; fear of injury while trying to open packaging; and, most importantly, fear of looking stupid.
Concerned about all of these factors, Global Closure Systems, a well-known closure manufacturer, sponsored an exercise in 2010 where 100 adults aged 60-80 tested one of their 28mm child-resistant closures on a glass dispensing bottle and one of their competitor's child-resistant closures on an identical bottle. The 100 panellists were chosen randomly and included 25 with serious and visible handicaps.
Surprisingly, everybody opened both containers within the one minute allowed. The quickest opening was performed in two seconds and the slowest in 56. The lesson learned, though, was simple: although the pack had a built-in impediment to opening by children, to adults, even elderly and handicapped ones, it was "obvious how and easy to do".
With all of this in mind, in 2011, BSI published the technical specification DD CEN/TS 15945:2011 (Packaging - Ease of Opening - Criteria and Test Methods for Evaluating Consumer Packaging). This specification tests packs with panels of adults aged 65-80, to more closely mirror the population.
In addition to testing existing packaging, though, more attention needs to be paid to designing openability into it from the start. For this reason, work is now well advanced on the creation of a new international standard, ISO/CD 17480 (Packaging - Accessible Design - Ease of Opening). ISO will issue a draft for public comment in mid-2013 with a view to publication in early 2014.
In all the circumstances, it may be fairly said that, as well as saving children's lives, child-resistant packaging has done much to catalyse better packaging for elderly people.
It is therefore surprising that very many medicines in the UK are packed in non-reclosable packs, usually blister packs, that are simply not child-resistant. They are not tested in accordance with BS EN 14375, and certainly wouldn't comply if they were. This major anomaly has come about because the regulations are aimed at over-the-counter medicines and only refer to medicines containing aspirin, paracetamol and iron. Packaging for prescription medicines is covered by practice direction from the Royal Pharmaceutical Society. This direction specifies the use of child-resistant packs for dispensing, except when the medicines are dispensed in original factory packs, namely non-child-resistant blister packs. Of course, when the direction was first written, very few medicines were dispensed in such packs; but now the converse is true.
This problem was recognised by the WHO in its 2008 world report. Here, it described the use of such packs as "potentially harmful" and in its recommendations made special mention of the dangers of non-child-resistant blister packs.
The remedy, though, lies firmly in the hands of the regulators. In the US, there is a federal regulation for packaging medicines. In Europe, we have a pan-European regulation for the packaging of non-medicines in EC No 1272/2008. And there is no good reason we cannot have a European regulation for medicine packaging as well.