Conferences, Articles, Speeches
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Date posted: Tuesday 15 May, 2001 at 10:55am
Page Title: Child Resistant Flexible Packs in the European Union
Paper presented at Pharmaceutical and Medical Packaging 2001
11th International Conference. 15-16 May 2001, Copenhagen, Denmark
By Stephen Wilkins
Child Resistant Flexible Packs in the European Union - The Technology and the RegulationsSection 1 ??? The History, Regulations & Technology
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 exists only in the United States, Canada, New Zealand, Australia, United Kingdom, Germany and Italy. ??? But more of that later.
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 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 garden products, were subject to separate regulations where two classifications, ???hazardous??? and ???very hazardous??? required CR packaging. In the United Kingdom these 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 States, thence Canada, Australia, New Zealand and Germany ??? about which more later.
Reverting to the United Kingdom and other EU countries, in an effort to bring blister packs within the ambit of child protocol testing, BS EN 862 was published in 1997, this standard covered blister packs and other non-reclosables, but excluded those which contained pharmaceuticals.
I now refer to the technology.
Reclosable child resistant packaging solutions obtain their child resistance by either asking the user to undertake two opposing actions simultaneously, thus creating a barrier of dexterity. Examples are push down & turn - the classic Clik Lok or KidloK, squeeze & turn, or procedures for lining up the arrows and then opening; this is a barrier of cognisance as well as dexterity
Non-reclosable products usually contain a barrier of cognisance, in other words ???fold at 45degrees and thus reveal a hidden tear start.??? Or ???peel back and push??? ??? a two stage opening procedure.
A problem though emerges because the definition of child resistant packaging is
?????packaging that is difficult for a child to open within a reasonable period but that presents no difficulty for an adult to use properly.???
And flexible packs with hidden tear starts or peel back and push blister packs did and still do present problems for elderly or handicapped people to use properly.
This is less of a problem in the United States because blister packs have very little penetration. But it is a problem here in Europe.
Before I leave this introduction, I have to stress the importance of openability of CR packs by adults, particularly elderly or handicapped ones.
If adult users are not confident of being able to open their medicine packaging they will decant into convenient containers, like cream jugs, and the whole ???raison d?????tre??? of child resistant packaging of a potentially harmful product is immediately compromised.
Section 2 ??? Bringing blister packs into line; a campaign catalysed by the Patient Pack Initiative The Child-Safe Packaging Group was formed by the greater part of the supply industry for reclosable pharmaceutical packaging in the United Kingdom.
Since formation in early 1995 membership has expanded and presently the group consists of 15 member organisations; 12 in the UK and 3 in North America and Canada.
The group has developed its objective. Initially it was
?????to create a level playing field of testing for child resistance for all products that could contain harmful substances, reclosable and non-reclosable.???
The objective is now
???The promotion, specification and success of child resistant packaging solutions for all products whose ingestion or other exposure could cause serious distress to a child.???
But why the formation of this group? After all child resistant packaging was then in its twentieth year in the UK and could be called a mature product. The catalyst was the Patient Pack Initiative, which grew to prominence in 1994/5. The Patient Pack ...
Read more...
Paper presented at Pharmaceutical and Medical Packaging 2001
11th International Conference. 15-16 May 2001, Copenhagen, Denmark
By Stephen Wilkins
Child Resistant Flexible Packs in the European Union - The Technology and the RegulationsSection 1 ??? The History, Regulations & Technology
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 exists only in the United States, Canada, New Zealand, Australia, United Kingdom, Germany and Italy. ??? But more of that later.
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 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 garden products, were subject to separate regulations where two classifications, ???hazardous??? and ???very hazardous??? required CR packaging. In the United Kingdom these 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 States, thence Canada, Australia, New Zealand and Germany ??? about which more later.
Reverting to the United Kingdom and other EU countries, in an effort to bring blister packs within the ambit of child protocol testing, BS EN 862 was published in 1997, this standard covered blister packs and other non-reclosables, but excluded those which contained pharmaceuticals.
I now refer to the technology.
Reclosable child resistant packaging solutions obtain their child resistance by either asking the user to undertake two opposing actions simultaneously, thus creating a barrier of dexterity. Examples are push down & turn - the classic Clik Lok or KidloK, squeeze & turn, or procedures for lining up the arrows and then opening; this is a barrier of cognisance as well as dexterity
Non-reclosable products usually contain a barrier of cognisance, in other words ???fold at 45degrees and thus reveal a hidden tear start.??? Or ???peel back and push??? ??? a two stage opening procedure.
A problem though emerges because the definition of child resistant packaging is
?????packaging that is difficult for a child to open within a reasonable period but that presents no difficulty for an adult to use properly.???
And flexible packs with hidden tear starts or peel back and push blister packs did and still do present problems for elderly or handicapped people to use properly.
This is less of a problem in the United States because blister packs have very little penetration. But it is a problem here in Europe.
Before I leave this introduction, I have to stress the importance of openability of CR packs by adults, particularly elderly or handicapped ones.
If adult users are not confident of being able to open their medicine packaging they will decant into convenient containers, like cream jugs, and the whole ???raison d?????tre??? of child resistant packaging of a potentially harmful product is immediately compromised.
Section 2 ??? Bringing blister packs into line; a campaign catalysed by the Patient Pack Initiative The Child-Safe Packaging Group was formed by the greater part of the supply industry for reclosable pharmaceutical packaging in the United Kingdom.
Since formation in early 1995 membership has expanded and presently the group consists of 15 member organisations; 12 in the UK and 3 in North America and Canada.
The group has developed its objective. Initially it was
?????to create a level playing field of testing for child resistance for all products that could contain harmful substances, reclosable and non-reclosable.???
The objective is now
???The promotion, specification and success of child resistant packaging solutions for all products whose ingestion or other exposure could cause serious distress to a child.???
But why the formation of this group? After all child resistant packaging was then in its twentieth year in the UK and could be called a mature product. The catalyst was the Patient Pack Initiative, which grew to prominence in 1994/5. The Patient Pack ...
Read more...
Date posted: Thursday 23 September, 1999 at 12:49pm
Page Title: Child Resistant Closures In The United Kingdom
Child Resistant Closures In The United Kingdom
For The Closure Manufacturers Association
Introduction
Ladies and Gentlemen Good Morning.
Firstly let me say what an honour and a privilege it is to address you here in Chicago this morning.
As your chairman said when he introduced me I am the Secretary of the Child-Safe Packaging Group in the UK. Secretary is one of those peculiar British words you know and it can have a multitude of meanings.
Some would argue that in my case it means chief bottle washer! Or even lord high everything else. But it is true to say that over the past four and a half years I have project managed and driven every initiative that has been undertaken by the Child-Safe Packaging Group.
CSPG
This group represents the greater part of the supply industry for reclosable child resistant packaging in the UK, most of them closure manufacturers. You can see on the screen that our membership is truly impressive.
I would like to start now by giving you some background into child resistant packaging in the UK, perhaps draw some distinctions between the way we have tackled the subject and way that you have done so here in the United States. I will then go on to tell you how this group was formed and its initial and continuing objectives, and then I will finish by saying what we have achieved, where we are now and what we have yet to achieve in our mission to promote child resistant packaging solutions wherever the packaged product could cause distress to a child if they, either ingest it or come into contact with it in some other way.
CR Packaging In the UK
In the UK our decade of consumerism occurred somewhat later than yours; perhaps we did not have a Ralph Nader to drive it?
But it can be fairly said that the 1970???s saw the greater part of the UK???s consumer legislation being enacted. Amongst this plethora of regulation was the 1975 Medicines (Child Safety) regulations. Initially these regulations were applicable only to childrens Aspirin and Paracetamol. Although subsequently increased to include adult versions of these drugs, Aspirin and Paracetamol remained the only products where child resistant packaging is legally required.
Its use elsewhere arises solely as a piece of self-regulation by either the pharmaceutical industry, the Royal Pharmaceutical Society or other manufacturers or retailers.
The move to child resistant packaging gave rise to products which you will find familiar ???
Push down & turn CRC???s
Double walled squeeze & turn closures
Single walled squeeze & turn closures
Jigger cap CRC???s
And Line up the arrow systems
The regulations were drafted by a committee of physicians, pharmacists and pharmaceutical manufacturers but sad to say not one packaging designer or engineer. And it is probably for this reason that the anomaly of blister and strip packs first came into being and has continued to this day.
Keep in mind blister and strip packs were fairly rare in the UK back in the early 1970???s. However the regulations initially said, and I quote, "Blister packs should be constructed from materials with a view to making them child resistant."
Over the intervening years between the mid 70???s and late 90???s this rather woolly specification grew into the dictum, again quoting, "Blister packs may be considered to be inherently child resistant".
The ascription of inherently child resistant was first given to blister packs by the National Pharmaceutical Association in the UK and based upon work undertaken by H.M. Wiseman et al (1987) and an extrapolation of Wiseman???s work published by the Proprietary Association of Great Britain (PAGB) also in 1987. Interestingly it was the PAGB that sponsored Wiseman???s study, and, to explain, the Proprietary Association of Great Britain is the industry group representing manufacturers of over the counter medicines and preparations in the United Kingdom. It just could be that the 1987 research was self-serving for its sponsor. However I must stress ??? it just could be.
Now remember these were not peel and push or any other system requiring, for example, an element of understanding or cognisance, they were simple push through PVC and foil blister packs.
In 1995 the UK Government, in response to EU directive 92/27EEC concerning patient information, launched what it termed the Patient Pack Initiative. Part of this project included the dispensing of prescription drugs ex-factory in quantities of fixed numbers of daily doses.
Pharmacists would no longer count out tablets or capsules, but manufacturers would pack ready for dispensing. As well as constraining the physicians authority to dispense in the exact number that he or she considered proper, this directive acted consciously or unconsciously to promote the use of blister packs, the majority of which, because they were manufactured solely from PVC and alu foil were essentially a less good non-child resistant product, and enjoyed a cost advantage over child resistant closures and reclosable con ...
Read more...
Child Resistant Closures In The United Kingdom
For The Closure Manufacturers Association
Introduction
Ladies and Gentlemen Good Morning.
Firstly let me say what an honour and a privilege it is to address you here in Chicago this morning.
As your chairman said when he introduced me I am the Secretary of the Child-Safe Packaging Group in the UK. Secretary is one of those peculiar British words you know and it can have a multitude of meanings.
Some would argue that in my case it means chief bottle washer! Or even lord high everything else. But it is true to say that over the past four and a half years I have project managed and driven every initiative that has been undertaken by the Child-Safe Packaging Group.
CSPG
This group represents the greater part of the supply industry for reclosable child resistant packaging in the UK, most of them closure manufacturers. You can see on the screen that our membership is truly impressive.
I would like to start now by giving you some background into child resistant packaging in the UK, perhaps draw some distinctions between the way we have tackled the subject and way that you have done so here in the United States. I will then go on to tell you how this group was formed and its initial and continuing objectives, and then I will finish by saying what we have achieved, where we are now and what we have yet to achieve in our mission to promote child resistant packaging solutions wherever the packaged product could cause distress to a child if they, either ingest it or come into contact with it in some other way.
CR Packaging In the UK
In the UK our decade of consumerism occurred somewhat later than yours; perhaps we did not have a Ralph Nader to drive it?
But it can be fairly said that the 1970???s saw the greater part of the UK???s consumer legislation being enacted. Amongst this plethora of regulation was the 1975 Medicines (Child Safety) regulations. Initially these regulations were applicable only to childrens Aspirin and Paracetamol. Although subsequently increased to include adult versions of these drugs, Aspirin and Paracetamol remained the only products where child resistant packaging is legally required.
Its use elsewhere arises solely as a piece of self-regulation by either the pharmaceutical industry, the Royal Pharmaceutical Society or other manufacturers or retailers.
The move to child resistant packaging gave rise to products which you will find familiar ???
Push down & turn CRC???s
Double walled squeeze & turn closures
Single walled squeeze & turn closures
Jigger cap CRC???s
And Line up the arrow systems
The regulations were drafted by a committee of physicians, pharmacists and pharmaceutical manufacturers but sad to say not one packaging designer or engineer. And it is probably for this reason that the anomaly of blister and strip packs first came into being and has continued to this day.
Keep in mind blister and strip packs were fairly rare in the UK back in the early 1970???s. However the regulations initially said, and I quote, "Blister packs should be constructed from materials with a view to making them child resistant."
Over the intervening years between the mid 70???s and late 90???s this rather woolly specification grew into the dictum, again quoting, "Blister packs may be considered to be inherently child resistant".
The ascription of inherently child resistant was first given to blister packs by the National Pharmaceutical Association in the UK and based upon work undertaken by H.M. Wiseman et al (1987) and an extrapolation of Wiseman???s work published by the Proprietary Association of Great Britain (PAGB) also in 1987. Interestingly it was the PAGB that sponsored Wiseman???s study, and, to explain, the Proprietary Association of Great Britain is the industry group representing manufacturers of over the counter medicines and preparations in the United Kingdom. It just could be that the 1987 research was self-serving for its sponsor. However I must stress ??? it just could be.
Now remember these were not peel and push or any other system requiring, for example, an element of understanding or cognisance, they were simple push through PVC and foil blister packs.
In 1995 the UK Government, in response to EU directive 92/27EEC concerning patient information, launched what it termed the Patient Pack Initiative. Part of this project included the dispensing of prescription drugs ex-factory in quantities of fixed numbers of daily doses.
Pharmacists would no longer count out tablets or capsules, but manufacturers would pack ready for dispensing. As well as constraining the physicians authority to dispense in the exact number that he or she considered proper, this directive acted consciously or unconsciously to promote the use of blister packs, the majority of which, because they were manufactured solely from PVC and alu foil were essentially a less good non-child resistant product, and enjoyed a cost advantage over child resistant closures and reclosable con ...
Read more...
Date posted: Wednesday 14 October, 1998 at 12:51pm
Page Title: Packaging For??The Third Age Presented As Part Of Retail Pack98
Paper presented at Retailpack 98,
Wednesday 14th October 1998,
as part of Packaging for the 3rd Age -
Stephen Wilkins, The Child-Safe Packaging Group.
A number of special problems become apparent when pharmaceuticals or other potentially hazardous products are packaged. Here in the UK the regulations concerning child resistant packaging originated in 1975 as the "Medicines (Child Safety Regulations)". And after really very little changes during the intervening twenty three years have now emerged as BS EN 28317, the English language version of ISO 8317.
Here in the UK we are obliged to use child resistant packaging only for aspirin and paracetamol although, needless to say, CRC???s are used for many other products.
In addition, although unit dose packaging, namely blister and strip packs, are not tested for child resistance if their use is the packaging of pharmaceuticals, they are subject to testing for other potentially hazardous unit and dose products. This blister pack testing standard is BS EN 862.
Here is a definition of child resistant packaging, it is: " packaging that is designed and constructed to be difficult for young children to open within a reasonable time and that is not difficult for adults to use properly."
Both of the two standards to which I have referred, namely BS EN 28317 and BS EN 862, assess child resistance based upon a sequential test of a panel of children. Because of the complex nature of children???s abilities, child resistant effectiveness is panel tested; thus far the only method of testing that has been accepted by elements of the industry and the ...
Read more...
Paper presented at Retailpack 98,
Wednesday 14th October 1998,
as part of Packaging for the 3rd Age -
Stephen Wilkins, The Child-Safe Packaging Group.
A number of special problems become apparent when pharmaceuticals or other potentially hazardous products are packaged. Here in the UK the regulations concerning child resistant packaging originated in 1975 as the "Medicines (Child Safety Regulations)". And after really very little changes during the intervening twenty three years have now emerged as BS EN 28317, the English language version of ISO 8317.
Here in the UK we are obliged to use child resistant packaging only for aspirin and paracetamol although, needless to say, CRC???s are used for many other products.
In addition, although unit dose packaging, namely blister and strip packs, are not tested for child resistance if their use is the packaging of pharmaceuticals, they are subject to testing for other potentially hazardous unit and dose products. This blister pack testing standard is BS EN 862.
Here is a definition of child resistant packaging, it is: " packaging that is designed and constructed to be difficult for young children to open within a reasonable time and that is not difficult for adults to use properly."
Both of the two standards to which I have referred, namely BS EN 28317 and BS EN 862, assess child resistance based upon a sequential test of a panel of children. Because of the complex nature of children???s abilities, child resistant effectiveness is panel tested; thus far the only method of testing that has been accepted by elements of the industry and the ...
Read more...
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