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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...
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