Child Safe Packaging Group

Developments in Child Resistant Packaging Solutions & Imminent New Standards & Legislation

Date of page: Mon 09 Jul 2001 at 7:44pm

By Stephen Wilkins

Within the context of improving packaging accessibility and functionality, child resistant packaging presents a series of special problems; or to the designer a series of special challenges.

It is well to remember that from the outset child resistant packaging is designed to resist opening by a proportion of those who might encounter it, namely children, but to be easily accessible by adults.

Here is the definition of child resistant (CR) packaging ??-

???Child resistant packaging is packaging that is difficult for children to open within a reasonable period but that presents no difficulty for adults to use properly???

Another point to bear in mind is the comment, which you will have heard today, concerning packaging related injuries. The figure of 60,000 occurrences has been quoted, but in fact that figure excludes accidents related to medical or pharmaceutical packaging, those are almost half as many incidents again. Indeed our own research indicates not 30,000 but 45,000. More about all of this later though.

THE HISTORY, REGULATIONS & TECHNOLOGY

OF CHILD RESISTANT PACKAGING

Child resistant packaging emerged in the United States with the Poisons Prevention Packaging Act of 1970. The 1975 Medicines (Child Safety) Regulations in the United Kingdom specified child resistant packaging for some pharmaceuticals, initially solid dose children???s aspirin and paracetamol and subsequently adult versions of these drugs. The UK was the first European Union country to utilise CR packaging, and the second country after the United States. Indeed, even today standards for CR packaging and a legal duty to use the product exist only in the United States, Canada, New Zealand, Australia, United Kingdom, Germany and Italy.

So what makes a product child resistant? The definitive test is in fact a protocol test where a sample of children is used and asked quite simply to open the pack being tested. The sample is allowed two sessions; five minutes, and then a silent demonstration then a further five minutes. The pack fails, that is, is not considered child resistant, if fifteen percent of the sample open it, prior to demonstration, or twenty percent open it post demonstration.

Sequential testing is used, in other words because each result is plotted on a rising curve with tolerances, a pack can pass or fail using considerably less than the full quota sample.

In the United Kingdom the standards for reclosable CR packaging have been BS 5321 (1975), BS 6652 (1985), BS EN 28317 (1989) and subsequently ISO 8317, this was revised in 2000.

The standards differed primarily in sample size, sample composition and stringency. Adult tests were incorporated as the concept of adult openability assumed increasing importance. For example the latest version of ISO 8317 (2000) has changed the adult age range from 45 to 65 years inclusive to 50-70 years inclusive. This brings the standard into line with the United States protocol and mirrors the advancing age of the population.

In the United Kingdom the only pharmaceutical products requiring to be packed in CR containers were children???s aspirin and paracetamol, and subsequently adult versions of these preparations. Non pharmaceuticals, for example household products, toiletries and horticultural products, were subject to separate regulations where two classifications, ???hazardous??? and ???very hazardous??? required CR packaging. In the United Kingdom these regulations are CHIPS II.

All of the standards to which I have referred cover reclosable child resistant packaging. But non-reclosables ??? blister and strip packs, were accorded the ascription of child resistance if ???designed with a view to being child resistant.??? (1975 Medicines (Child Safety) Regulations) This was a classic ???begging of the question??? whereby a proposition itself subject to proof was held up as proof.

The situation differed in the United States, thence Canada, Australia, New Zealand and Germany ????? about which more later.

Reverting to the United Kingdom and other EU countries, in an effort to bring blister packs within the ambit of child protocol testing, BS EN 862 was published in 1997, this standard covered blister packs and other non-reclosables, but excluded those which contained pharmaceuticals.

I now refer to the technology.

Reclosable child resistant packaging solutions obtain their child resistance by either asking the user to undertake two opposing actions simultaneously, thus creating a barrier of dexterity. Examples are push down & turn - the classic Clik Lok or KidloK, squeeze & turn, or procedures for lining up the arrows and then opening; this is a barrier of cognisance as well as dexterity

Non-reclosable products usually contain a barrier of cognisance, in other words ???fold at 45degrees and thus reveal a hidden tear start.??? Or ???peel back and push??? ??? a two stage opening procedure.

A problem though emerges because the definition of child resistant packaging, which I reiterate, is

?????packaging that is difficult for a child to open within a reasonable period but that presents no difficulty for an adult to use properly.???

And flexible packs with hidden tear starts or peel back and push blister packs did and still do present problems for elderly or handicapped people to use properly.

This is less of a problem in the United States because blister packs have very little market penetration. But it is a problem here in Europe.

I have to stress the importance of openability of CR packs by adults, particularly elderly or handicapped ones.

If adult users are not confident of being able to open their medicine packaging they will decant into convenient containers, like cream jugs, and the whole ???raison d?????tre??? of child resistant packaging of a potentially harmful product is immediately compromised.

Bringing blister packs into line; a campaign ????????????????????????

catalysed by the Patient Pack
Initiative

The Child-Safe Packaging Group was formed by the greater part of the supply industry for reclosable pharmaceutical packaging in the United Kingdom.

Since formation in early 1995 membership has expanded and presently the group consists of 15 member organisations; 12 in the UK and 3 in North America and Canada.

The group has developed its objective. Initially it was

?????to create a level playing field of testing for child resistance for all products that could contain harmful substances, reclosable and non-reclosable.???

The objective is now is

???The promotion, specification and success of child resistant packaging solutions for all products whose ingestion or other exposure could cause serious distress to a child.???

But why the formation of this group? After all child resistant packaging was then in its twentieth year in the UK and could be called a mature product.

The catalyst was the Patient Pack Initiative, which grew to prominence in 1994/5. The Patient Pack Initiative, which advocated original pack dispensing, was a result of European Directive 92/27/EEC. Amongst other things this directive called for two very laudable improvements to pharmaceutical packaging. These were clear labelling and the inclusion of a patient information leaflet.

The question might be asked ??? where did we come in? Well, blister packs then produced in the UK and still produced now, are simply not child resistant. They consist of foil laminated to PVC blisters, they are cheap and very openable indeed, particularly by the elderly and even more particularly by children.

In early summer 1995 the Child-Safe Packaging Group tested a series of blister packs then and now widely used in the United Kingdom. The protocol was the then current US standard. Using sequential testing a sample of forty children was employed. ??The results were disturbing but predictable.

???????????????? 92.5% of the sample of forty children accessed at least three tablets from the blister pack prior to demonstration.

???????????????? 45% accessed all fifteen tablets, again prior to demonstration.

???????????????? 90%, after ten minutes testing, had accessed all fifteen tablets.

???????????????? Only one child had accessed less than three tablets.

These results were worrying in view of the fact that three adult paracetamol tablets can be fatal to a child.

There is a standard to which blister packs need to comply, that is BS 7752, this specifies materials and dimensions, particularly lack of rattle, and is based upon research undertaken in 1987 by H.M. Wiseman, G, Volans and others. This standard does not include any child testing or mechanical testing.

The Wiseman, Volans work did avoid a number of questions and indeed its findings were subsequently discredited by Wilbur & Barone ??? published by the Consumer Product Safety Commission in the United States (CPSC- 1998).

However, the Wiseman, Volans work did, at the time, anchor, then totally untested blister packs into the firmament of child resistant packaging and effectively gave brand owners and packer/fillers licence to manufacture and use that system with no real fear from the UK???s Consumer Protection Act 1987 or subsequent European Union product liability directives.

Before I discuss the imminent new standard for protocol testing blister packs for pharmaceuticals, let us think for a few moments about all the functions of packaging.

Clearly, packaging secures and protects, and for years that has been considered its primary function. But it does more than that ??? packaging brands; just as many other things brand and say things about the user as well as the product. But in the case of complex products, like pharmaceuticals or many household products, packaging has a mission to explain or it must be capable of carrying with it explanatory information.

New directive 92/27/EEC in the case of medicines, formalised that mission to explain. Many of us here will remember grandparents and parent who grew up and spent most of their lives in the belief of ???Doctor knows best,??? or ???keep on taking the tablets???. Contra indications or side effects were to them almost unknown terms. Indeed it was this lack of knowledge of precisely what medication does that led many patients to demand antibiotics from a harassed prescriber for conditions against which antibiotics were totally ineffective.

Unfortunately though medicine packaging???s mission to explain overtook its mission to protect and the pharmaceutical industry embraced simple PVC and foil blister packs because the explanation, the patient information leaflet, could easily slip into the small cardboard carton ??? the secondary packaging.

And, by comparison with rigid child resistant packaging, the whole arrangement was cheap, particularly for the patient pack quantity ??? 28 doses.

The campaign, discussions, negotiations and controversy surrounding untested and unsafe blister packs has continued over the last five years. But it was only last year, catalysed by the death of a toddler who ingested ferrous sulphate tablets, that the BSI was motivated to fast track a new British Standard, which is equal in all respects to the existing German Standard DIN 55 559 and, in terms of testing procedure, to BS EN 28317; our own standard to which non reclosables are subject and the standard that has driven child resistant packaging as we know it.

In the United States of America blister packs have, since the late 1960???s early 1970???s been required to be child resistant, and the technique of achieving child resistance has been peel back instead of push through. This is effective but it is exceptionally difficult for elderly and handicapped people to use.

Try to imagine what it is like to be an elderly or handicapped person.

???????????????? Wear cracked spectacles to simulate cataracts.

???????????????? Coat your fingers in talcum powder to simulate reduced tactile sensitivity.

???????????????? Imagine a kilo of sand strapped to your left ankle to simulate the symptoms of a stroke.

???????????????? Imagine children???s armbands or buoyancy aids attached to your elbows to simulate the effects of arthritis.

And now try and open some pharmaceutical packaging.

In the United Kingdom blister packs have, over the last five years, encroached upon market territory that had traditionally been occupied by reclosable CR solutions and with the publication this autumn of the new British Standard brand owners and packer/fillers will be faced with a problem. Do they search for CR blister packs or do they revert to tried, tested and useable non-reclosables?

Let us revert for one moment to packaging???s primary function. The function to protect. Blister packs have a unique ability here in that in the case of tablets, each is kept in a totally separate compartment ensuring no contact with any other tablet, no degradation and very little or no contact with air.

Where this level of protection is required then child resistant blister packs that are also senior friendly need to be produced. That is always assuming that the product being packaged could cause serious distress to a child if ingested or otherwise exposed. Where the level of protection afforded by blister packs is not required then there is no good reason to abandon tried and tested reclosables.

We have undertaken some development work and sponsored design competitions and patent applications for such products. Here are some examples.

(Slides)

Recognising that child resistance comes about through either a straight barrier, beyond the strength of a child to break; usually though beyond the strength of an adult too, a barrier of cognisance or a barrier requiring two opposing actions to be undertaken simultaneously, one of dexterity, we have been encouraged by some of our development work and that of various packaging manufacturers in this country and the United States.

Algroup Wheaton in Germany has made tremendous strides in this area and SmithKline Beecham here in the United Kingdom has also been experimenting with blister packs, which disguise the existence of the blister. Though I do not as yet think that these have been tested for child resistance.

My challenge to the design industry is let us meet the need for child resistant flexible packs head on by designing better packs. There is nothing to be proud of in fudging the issue, in pretending that a non-child resistant pack can be made to qualify under a modified standard. There are no prizes for creating a standard whose sole benefit is that it is easy to comply with.

What is required in the European Union is a sea-change in packaging technology to ensure that as we in Europe become the biggest consumer, we are also the biggest and the best, the most effective, the most efficient and the most elegant producer.

In its short life the Child-Safe Packaging Group has amassed a substantial volume of research data and empirical evidence. This is available to members.

Those who would seek to design or endeavour to design CR packs will derive real competitive advantage from so doing. Our research information is available not only to our members but also to designers on a pro bono basis.

At the Closure Manufacturers Association???s Technical Conference in Chicago, Illinois, October 1999, I quoted from one of those airport bookstall publications ???Great products of the 20 th Century ??? Century Makers,??? that the Child resistant cap was one of the most important products to emerge during the last century. I wonder if it is possible to ensure universally applicable senior friendly child resistant flexibles are one of this century???s most important products.

Ends

Stephen Wilkins

Monday, 09 July 2001