the packaging of a product must address the requirements of american, european or international standards to be tagged as a child resistant. stephen wilkins, who is the chief executive at the childsafe packaging group and holds the position of director at davies devlopment and testing ltd, put forwards his views. en 14374 2003 for nonreclosable and en iso 8317 2004 for reclosable containers packs are two most famous and common standards for childresistant pharmaceutical packaging in the eu. both of these standards are anticipated for kind approval and iso 8317 covers up the entire package, and not just the closure. hence, a change of container closure or shape modifications will call for a retest. the standards consist of two trials, one for adults and the other for children. in the child test, almost 80 per cent kids from a variable panel ageing from 4251 months old must not be able to open the pack. kids are given the time of two fiveminute periods, and during this periods, they witness a silent demonstration. as far as the adult test in concerned, a sample of 100 adults, aged from 50 and 70 years, is asked to open as well as reclose the pack. the task may also include opening packaging extracting one unit in a minute. 90 per cent adults must succeed in these tasks for the pack to comply with the standard. for almost 40 years, with minor variations, this type approval system has been in operation. furthermore, the standards are generally operated and testing is performed by sovereign laboratories that fulfill the iso 17025international lab standard. even as indication is made to mechanical data being utilized to demonstrate compliance in the case of an array of minor changes and same packaging bs en iso 8317sections 3.1 and 4.1, no regulations are given for the utilization of that data as well as there are no replicas for mechanical tests. in simple words, this means that brand owners or producers must either develop their own data treatment systems and test models, or face the expenses of repetitive panel testing. in a few cases, unfortunately it has meant that slight changes have been done to packs and no new panel testing or data comparison has been done. some years ago, it was the british standards institute bsi which recognized this wouldbe problem. the packaging solution was either a completely new international or european standard dealing exclusively with mechanical testing, or a considerable revision of bs en iso 8317 to comprise mechanical testing. the latter option was chosen and draft standard pr en 13127 entitled packagingchild resistant packagingmechanical test methods for reclosable child resistant packaging systems should &ndash after a final vote &ndash be published as a european standard early in 2012. to develop the draft to this, it has taken about seven years its last stage and the larger part of the development drive has come from the uk packaging industry and the bsi. the draft standard of mechanical testing consists of a risk evaluation tool that addresses the questions do we retest fully or partially, or do we use a mechanical examination model and, if yes, which one furthermore, it contains 10 testing models with their astm counterparts, as well. these testing methods or models have isolated the decisive success aspects of all reclosable childresistant packaging structures as well as they also work on the base of evaluating data from the similar or modified pack on test with the similar data from the inventive pack that was examined under bs en iso 8317. instances are the squeeze examination meant for squeezeandturn closures and the reverseratchet torque test, the turn engagement and press down test, and the disassembly test for twopiece pushandturn closures. to childresistant packages, there are several areas of slight variation as those packs create, that will shortly be able to be examined effectively and efficiently as well as certified to a european standard. this can only help packaging manufacturers and brand owners but, most significantly, users, specifically households with small kids. regardless of the huge amount of attempt that has been put in by both the standards writers and the industry &ndash to ensure more rigorouslytested, better, and by corollary more usable, more environmentallysound, and more easilymodified childresistant packaging &ndash concerns remain. the administrators, in this case the mhra, are continuing to put lives of kids at risk by letting prescription medicines be packaged in flexible nonchildresistant packs. source of information httpretailpackagingmag.co.ukstandardonhorizon
