Child Safe Closure – The Importance of Compliant Packaging

Child safety is a subject of increasing importance within the circle of pharmaceutical primary packaging experts supplying the pharmaceutical industry. The scope of products to which Child Safe Closures are being applied is increasing significantly and is the largest single cause for pharmaceutical packaging re-design in some organisations.

Child Safe Closures come in a range of styles and a host of mechanisms exist, some are effective and some are ineffective. Some are clearly designed for the intended purpose and others are clearly attempts at removing cost either by weight reduction or by poor quality of production tooling.

The recent publication of ISO17480 adds senior open-ability to the challenges of child safety. Child Safe Closure packaging must be designed to enable the elderly patient to access their medication with ease. The same pack must be of sufficient complexity to prevent a child gaining access to potentially harmful medicines. These risks are high, the insatiable demand for low cost infant resitant packaging is inevitably providing entry for a quantity of poorly designed Child Safe Closures to reach the shelves. Anyone who has had experience in child ingestions knows this risk is too great to take.

Integrity testing of closures is closely regulated and only a small number of facilities exist. The tests are stringent and follow strict protocol. That said there is probably scope for improvement – the current testing allows a small percentage of openings or failures and it becomes a matter of ethics whether companies will strive for zero open-ability results in the design of their Child Safe Closures.

In brief, a well-designed child safe closure will prevent a panel of 42-51 month old children from opening the primary packaging. If they haven’t successfully opened the closure / bottle within 5 minutes they are shown how to do this – and then given a further 5 minutes to try and open it. A child safe closure (pack) should be impossible for at least 85% of children, to open in the first five minutes (why we permit the remaining 15% to access the product is worthy of debate)!

Certainly child ingestions are devastating. Beyond the tragic effects on innocent life, every incident carries potential claims and recriminations that we ignore at our peril. Why the effectiveness of is not more actively monitored and challenged by the authorities – or at least by brand owners is a matter for speculation. It may shock our reader to know that the very term Child Safe Closure is an anomaly, in fact they don’t exist – in isolation. Child Safe Closures are only constituted as such when tested as a pack – including the container.

Compliant child safe closures are manufactured specifically to suit the bottle they are to be used with. Most suit threaded bottle necks and operate on the ‘push down and turn’ or ‘squeeze and turn’ principles. Push and turn Child Safe Closures are dependent on specified application torques. Squeeze and turn are not so.

Certain products, by law requires a child resistant closure to prevent child from swallowing any of the contents. Child Safe Closures have to meet or exceed the requirements of BS EN ISO 8317 in the UK and Europe whilst 16CFR1700 is the appropriate test Standard in the U.S. These international Standards have both ethical and commercial significance, preventing child ingestions and brand damage!