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Child Safe Packaging Group

www.childsafepackagingroup.com

Conferences, Articles, Speeches

Displaying entries 1 to 7 of 10 in this listing.
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Packaging - Its impact on the Plastics Ind.
Date posted: Monday 05 July, 2004 at 3:57pm
Page Title: Packaging - Its impact on the Plastics Ind.

The Packaging Sector is an extremely important customer to the plastics industry and, according to the British Plastics Federation is the largest user of plastics, more than 37% of UK polymers ending up in packaging in one shape or another.

One type of packaging that has been particularly successful in the UK over the last thirty years has been child resistant (CR) packs. These are created by a child resistant closure (CRC) and bottle and child resistance is achieved by requiring two simultaneous actions for example - push down & turn or squeeze & turn. Originating in 1971 in the US, the child resistant closure was designed primarily for medicines and was adopted for that purpose in the UK in 1974, since when it has gone from strength to strength. According to the British Standards Institute (BSI) here in the UK and the Consumer Products Safety Commission (CPSC) in the United States, child resistant closures have ‘saved numerous lives.’ To be child resistant a closure needs to be type tested by panels of children aged 42 to 51 months and after two five minute test periods, one before and one after a demonstration, 80% must fail to open the pack for it to be child resistant. Child resistant packs also need to be tested by adults, indeed they are the only form of packaging that is mandatorily or routinely subjected t ...
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Conferences
Date posted: Friday 01 August, 2003 at 12:59pm
Page Title: Conferences
Conferences

The Child-Safe Packaging Group Conferences/Platforms/Meetings??????

The Child-Safe Packaging Group enjoys a presence on the Institute of Packaging Environmental and Safety Common Interest Group in Melton Mowbray. The CSPG has been successful in obtaining the general support of John Webb-Jenkins the Chief Executive of the IOP and the support of the group generally for the majority of the CSPG???s o ...
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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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Reconciling the Openability Needs
Date posted: Tuesday 10 September, 2002 at 5:14pm
Page Title: Reconciling the Openability Needs
Child Resistant Packaging - Reconciling the Openability Needs of an Ageing Population with the Increasing Demand for Child Safe Packs. 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) and, in its latest manifestation, ISO 8317 (2000).

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 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 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, which by measuring trends enables a success or failure to be ascertained after testing a minimum of 25 individuals. 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. This procedure is based upon AQLs of 10% before demonstration and 15% post demonstration. LQ 20% before demonstration and 25% post demonstration with both Alpha and Beta values of 5%.

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 t ...
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The Background, Current Regulations and Ideas
Date posted: Wednesday 13 February, 2002 at 5:25pm
Page Title: The Background, Current Regulations and Ideas for the Future
Child Resistant Packaging ??? The Background, Current Regulations and Ideas for the Future. 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) and, in its latest manifestation, ISO 8317 (2000).

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 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 formed from a specified set of materials, and clearly they are not designed for QC procedures

A Discussion Concerning the Standards All 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, which by measuring trends enables a success or failure to be ascertained after testing a minimum of 25 individuals. 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 ...
Read more...
Developments in Child Resistant Packaging Sol
Date posted: Monday 09 July, 2001 at 7:44pm
Page Title: Developments in Child Resistant Packaging Solutions & Imminent New Standards & Legislation
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 State ...
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Developments in Child Resistant Packaging Sol
Date posted: Monday 09 July, 2001 at 10:45am
Page Title: Developments in Child Resistant Packaging Solutions
Developments in Child Resistant Packaging Solutions & Imminent New Standards & Legislation 12th July 2001
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 qu ...
Read more...
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