Packaging technology has undoubtedly progressed, however, it is unclear as to whether this effort is paralleled in creating a suitable level of child resistance. In this article, Richard Quelch of Origin discusses some of the important aspects of making medicine packaging child resistant.
Child's play
Advancements in packaging technology are undoubtedly to be viewed as a progression, it is questionable, however, whether there is a parallel effort in creating the child resistant packaging necessary to ensure these products are safe for the environments they occupy.
There is an abundance of information and even some creative solutions available to the packaging industry, with the ease of access to online information manufacturers are able to appraise themselves in consumer and regulatory concerns and safety is no exception. There is, however, possibly a lack of understanding what truly constitutes child-resistant packaging and also a preparedness to await regulatory obligation before introducing protection.
Child resistant is not child proof
An important consideration is the terminology used in matters pertaining to child safety, rarely if ever is packaging child proof. The balance between child resistance and senior accessibility is challenging. Accommodating both aspects in packaging design for pharmaceutical products is a significant task, regulating such a conflicting scope is probably harder still.
Child resistance should, according to the ISO8404 standard (non re-closable), be considered the last line of defence, not the first. Whatever packaging is developed to meet the fine balance of abilities between children and seniors it should be always remembered that ‘child resistant’ is never ‘child proof’ and therefore the practise of keeping medicines out of sight and reach of children should be mandatory.
Senior friendly child resistance
In many ways, the senior accessibility aspect of packaging is less definable than the child resistance. With children, we have fairly prescribed parameters of ability in the child safe testing age bracket of 42 to 51 months. The scope of abilities present in the adult test panel however of 50–70 year olds presents a hugely different picture.
The loss of dexterity and in some cases the ability to coordinate is often diminished in our latter years. The key principles required in achieving effective child resistance are by definition the same principles needed to enable the ageing population. As our ageing population is also increasing and advances in medicine is enabling us to retain our independence longer, questions could be raised as to whether 70 is still a relevant top end age for the testing protocol.
Regulations and testing
We have effective and well recognised regulations for the safe containment of medicines and the necessity of a common test protocol has long been considered essential for these products. Re-closable packaging to BSEN ISO8317 and its American equivalent, 16CFR 1700.20 are still effective and the 2015 version of the ISO standard has cleared up some areas of confusion.
To gain approval the complete pack must be tested — container and closure. Whilst many pharmaceutical containers are produced with child resistance closures it is not possible to assume that because one pack combination passes another will also pass.
Testing in the UK is performed at UKAS approved test centres in accordance with the relevant test protocol. Marginal differences apply between the European and US procedures.
Some test centres provide an expedited ‘pre-application’ test service providing a smaller test panel for a lower cost (Origin can advise regarding this). The test conditions are as per the protocol and the results helpful in ascertaining whether there are any fundamental issues in the pack design.
The official test protocol requires 200 able-bodied children between 42 and 51 months and can be performed either with the full 200 contingent or by a method of sequential testing. For the adult test a panel of 100 is required between the ages of 50 and 70 years.
Compliance — how do I know?
With over 50 years’ experience in child safe packaging we know there are an increasing number of packs in circulation that cannot be considered child resistant. Research suggests to us that an assumption is often made that because a cap appears to have a push-and-turn mechanism it must be child resistant, however this is not a wise assumption.
We suggest a common practise should be to ask your supplier for a technical file and certificate of child resistance for the pack you are using. Remember that technically there is no such thing as a ‘child resistant cap’ as for a pack to be child resistant you should have a certificate of testing which specifies the container and cap.
If your product is sold within the UK and EU then the BSEN ISO8317 certificate is the correct document for your activities. If your product is to be sold in the US you will need the 16CFR1700.20 certificate to comply with the regulations currently in force in the US.