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The following entry was found:
Developments Towards Child Resistant Flexible
Date posted: Thursday 22 May, 2003 at 10:49am
Page Title: Developments Towards Child Resistant Flexible Packs
Child Resistant Packaging ??? Safety for Children, Openability for Adults and Developments Towards Child Resistant Flexible PacksBy Stephen Wilkins

Clinical Trials 2003, 21st ??? 22nd May, Madrid
The BackgroundInitially I would like to discuss the background to child resistant packaging, the development of standards throughout the European Union, their harmony and lack of harmony in some cases.

The last eighteen months has seen the publication of two new standards; in the UK BS 8404 covering flexible child resistant packaging for pharmaceuticals and Internationally ISO 8317 2nd Edition (April 2003) dealing with child resistant reclosable packaging but incorporating a number of important developments.

Finally, I shall look at some of the ways that the packaging industry has reacted to these changes and show some recent developments and ideas.

Firstly though the background.

Child resistant (CR) packaging emerged in the early 1970???s in the United Kingdom, and slightly later throughout other European Union Countries. Initially testing, using panels of children, was undertaken only for reclosable systems; the familiar bottle and child resistant closure. It was considered then and it continued to be believed until recently that flexible, or non-reclosable packs; the familiar blister or strip, were inherently child resistant.

The standards to which reclosables needed to comply have, during the past 27years, undergone change and modernisation to conform to the changing characteristics and needs of the population. In the UK the standards were BS 5321 (1975), BS 6652 (1985), BS EN 28317 then ISO 8317 and finally 8317 second edition April 2003.

Non-reclosables enjoyed the ascription of ???inherent child resistance??? until December 21st last year, through compliance with BS 7236 (1989), which did not specify child panel testing or testing by adult panels, merely materials, seal strength, seal integrity, freedom from rattle and resistance to bending. It was set out in the introduction to BS 7236 that if compliance was achieved the pack would ?????..(be) comparable to reclosable child resistant packaging in terms of child safety.???

It was easy to see that compliance with BS 7236 granted an element of protection in the event of prosecution for breach of consumer protection legislation or the EU directive on general product safety and would provide a suitable defence in the event of any civil action. Similarly it enabled lip service to be paid to the Royal Pharmaceutical Society???s practice direction that ???..prescription medicines should be packed in child resistant containers.???

In 1997 BS EN 862 was published, this standard was subsequently updated in 2001, it is entitled ??? Packaging ??? Child Resistant Packaging ??? Requirements and Testing Procedures for Non-Reclosable Packages for Non Pharmaceutical Products.

The major sea change in the standards to which flexible packaging need to comply arose though in December 2001 with the publication of BS 8404 (2001) entitled ??? Packaging ??? Child Resistant Packaging ??? Requirements and Testing Procedures for Non-Reclosable Packages for Pharmaceutical Products.

A child resistant non-reclosable packaging standard for medicinal products has been in existence in Germany since October 1980. Its reference number is DIN 55 559 and it was up-dated in October 1998.

All four standards are intended for type approval, in other words to certify products as child resistant when formed from a specified set of materials, and clearly they are not designed for QC procedures

A Discussion Concerning the Standards The three standards dealing with non-reclosables and the standard dealing with reclosables differ in a number of respects and it is worth setting down the major areas of difference to enable us to gain an understanding of the environment of the regulatory structure. If desired a more detailed comparison can be provided or dealt with during discussion.

The Child Test In the case of all standards the child sample consists of a maximum of 200 children aged 42 to 51 months, equal in distribution between boys and girls.

In all standards sequential testing is used for the child test, which by measuring trends enables a success to be ascertained after testing a minimum of 29 individuals, and a failure after only 5. This is achieved by plotting results as they occur, either above the previous result or immediately to the right of it, and when the resulting curve passes into either an acceptance or a rejection zone the pack will pass or fail.
If the total sample is used, in all cases, a pack will be considered child resistant if at least 85% of the children in the test panel shall be unable to open the package without a demonstration or at least 80% of the children in the test panel shall be unable to open the package after a demonstration.

The Definition of an Opening BS EN 862 ??? simply that the pack be opened.

DIN 55 559 ??? ???..a child is able to gain access to sufficient unit doses to cause severe injury or damage or to remove more than eight units.???

BS 84 04 ??? ?????the children are able to access more than eight units.???

ISO 8317 ??? A simple opening. The Test Period In the case of BS 8404, DIN 55 559 and ISO 8317 the test period is 5 minutes prior to a silent demonstration and 5 minutes after. In the case of BS EN 862 (2001) the period is 3 minutes prior to demonstration and 3 minutes after.

There is no satisfactory reason for the different test period, 3 minutes or 5 minutes, and clearly there is no satisfactory reason for the difference in the definition of an opening, viz. ??? ?????.more than 8 uni ...
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