This document discusses child resistant packaging and accessibility for elderly adults. It covers: - A conference on child resistance and accessibility for elderly people. - Regulations requiring child resistant packaging for hazardous products and some medicines. - Standards for child resistant packaging and testing involving children and adults. - The effects of aging on vision, dexterity, and mobility that make opening packages difficult for seniors. - Proposing a new standard to test package design and openability for elderly adults.

1. CSPG
Child Resistant Packaging and
Elderly People,
PIMS Leaders Summit.
10th and 11th February.
Berlin, Germany.
Stephen Wilkins

2. Anti-Counterfeiting.
The total system makes for effective
anti-counterfeiting.
Let us examine how the work we do
on child resistance and elderly adult
openability can help create that
system.

3. Patient Compliance.
Or Non-Compliance….
Some causes of non-compliance
■ Forgetfulness
■ Diminution of Symptoms
■ Unstructured treatment plan
■ Difficulty in accessing medicines

4. Child resistant
packaging.
Why do we do it?
What is it?
How do we get it right?

7. Daily Mail UK
online article
17th October 2015
“Worrying social experiment reveals how toddlers are
more likely to choose brightly colored bottles of
hazardous cleaning products than their own toys.”
http://www.dailymail.co.uk/femail/article-3275924/Worrying-social-experiment-reveals-toddlers-likely-choose-brightly-coloured-bottles-hazardous-cleaning-products-toys.html
Image Daily Mail UK

8. Daily Mail UK
online article
17th October 2015
“More than half of children pick hazardous products in social experiment.
Youngsters play with bleach, paint and dishwasher tablets in shocking film.
Dutch public service advert made after 7,500 chemical accidents recorded.”
http://www.dailymail.co.uk/femail/article-3275924/Worrying-social-experiment-reveals-toddlers-likely-choose-brightly-coloured-bottles-hazardous-cleaning-products-toys.html
Image Daily Mail UK

9. Daily Mail UK
online article
17th October 2015
“As the children are faced with the apparently worryingly tricky
choice, hidden cameras, eye-tracking sensors and heart rate monitors
measure their attraction to the different objects.”
http://www.dailymail.co.uk/femail/article-3275924/Worrying-social-experiment-reveals-toddlers-likely-choose-brightly-coloured-bottles-hazardous-cleaning-products-toys.html
Image Daily Mail UK
“The Dutch public
service video reveals that
50 per cent of the
youngsters went for stain
remover, 64 per cent
went for paint and most
shockingly 82 per cent
went for bleach.
In total, 51 per cent of the
children opted for the
household chemicals
over the toys.”

10. The regulations in the UK for medicines, there is
no Pan-European regulation for medicines.
But there is for other chemicals
Products containing:
Aspirin, Paracetamol,
or 24mg of elemental iron.
And children’s cough mixture.

11. CLP/GHS –
Became Fully Effective June 2015
Child Resistant packaging required for:
1. Products which poison on ingestion.
2. Products which cause skin damage on contact.
3. Products which cause damage to eyes on contact.
4. Products which cause damage to airways if their
fumes are inhaled.

12. Push down & turn and Squeeze & Turn
Child Resistant Packaging
The pack,
not just the
closure

13. The standards for child resistant
packaging
BS EN ISO 8317 2015 -
International Standard
for rigid packaging
BS EN 14375 2003 -
European standard for
flexible packaging for
medicines
BS EN 862 2005 -
European standard for
flexible packaging for
non-medicines
EuropeUnited States
16CFR 1700.20 - US
Standard for rigid &
flexible child resistant
packaging for all
regulated contents

14. The Child Test
■ Up to 200 children aged 42 to 51
months
■ Two period of five minutes, one before
and one after a silent demonstration, in
which to open it.
■ Pack passes if 80% of the sample are
unable to open the pack after the two
periods of five minutes
■ Number of participants limited by use
of Bayesian system of sequential
testing.
■ 42-51 months clear six months after
the maximum danger age for ingestion

15. Sequential Charts
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chi l d 30
Pre dem on str ati on se qu en tia l ch art
US Standard 16 CFR 1700.20:
European Standards BSEN ISO 8317 & 14375:

16. The Adult Test
■ 100 adults aged 50 to 70,
■ skewed 70% female,
■ half is evenly spread between 50 and 60
■ and the other half, not necessarily evenly spread,
between 60 and 70

22. Examples of prescriptions medicines in standard blister
packs with fully transparent PVC trays

26. How many elderly people
(65 and over)
are there in the world?
World 597 million 8.2% of the population.
EU 92.7 million 18.21% of the population.
Germany 20.9%,
Italy 20.8%,
France17.9%,
UK 17.3%.
By Contrast: USA 13.9%
Source CIA world fact book Dec. 2013

27. The Effects of Ageing
What’s it
like getting
old?
Cf. RNIB

28. Normal vision
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

29. Myopia
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

30. Macular Degeneration
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

31. Cataracts
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

32. Diabetic Retinopathy
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

33. Tunnel Vision
(source: Dr John Gill, Chief Scientist, RNIB)
The Adult Test

34. The Effects of Ageing
You lose fingertip
strength and friction
(source: Help The Aged)

35. You become wary and unsure
of your environment and your
medicines
(source: Help The Aged)
The Effects of Ageing

36. You are more prone to
falling
(source: Help The Aged)
The Effects of Ageing

37. Between 65 & 75 you lose 50%
of your manual dexterity
(source: Yoxall et all, Uni Sheffield)
The Effects of Ageing

38. The Effects of Ageing

39. The Effects of Ageing

40. Standards for
Ease of Opening
A standard is not a set of rules but a set of concepts
from which we create our own rules.
Keywords in standards:
Shall: Requirement.
Should: Recommendation.
May: Permission.
Can: Possibility or Capability.

41. A New Standard for
testing for Openability

42. A New Standard for
design criteria and testing

43. All of these can be difficult to open,
especially if you are old or infirm.

44. Just another way of
getting it right.
Child
Resistant two
shot moulding
with TPE

45. These packs are designed to
resist opening by children
But they have always been tested
for openability by adults

46. Test Criteria
Effectiveness - open in five minutes
Efficiency - open in one minute
Satisfaction - indicated on the scale
Shown below

47. 35 panel members,aged 65 - 69
35 panel members, aged 70 -74
30 panel members, aged75-80
70% female
Sample configuration

48. Included in the Sample
2 confined to wheelchair
3 with major motor problems
9 with major dexterity problems
11 with problems of cognisance

49. When tested by our random
panel of 65-80 year olds……
Every one was opened. Quickest 2 seconds.
Slowest 56 seconds. Mean 8 seconds.

50. Conclusions
1. By its nature a push and turn CR
pack is ‘Obvious how and easy to
do.’
2. Other reclosable CRC’s and CR
blister could have difficulty in
meeting that standard.

51. BS ISO 17480:2015
Packaging-Accessible Design-Ease of Opening.
“Consumer packaging, both reclosable
and non- reclosable, which will not require
secondary mechanical means.”
(from the standard’s scope)

52. Definitions.
Consumer Packages:
Openability
Strength
Dexterity
Cognition Evaluation:
both instrument and user
based
Packaging:
Reclosable
Pull tab
Full opening
Stay on tabBS ISO 17480:2015

53. Accessible Design
Context
Strength
Dexterity
Cognition
Location
Methods & Mechanisms
Force & Handling
Reclosing
BS ISO 17480:2015

54. Evaluation
Instrument based
(quantitative data only)
Panel based
(qualitative data)
BS ISO 17480:2015

55. Conformance
BS ISO 17480:2015
By satisfying all the requirements of the
International Standard.
The procedure & detail to be specified and is a
matter for negotiation between the involved
parties
There is an informative annex entitled ‘conformance checklist’
but this is not a requirement, merely a suggestion

56. Informative Annexes
BS ISO 17480:2015
Opening types
Mechanical evaluation methods
Human strength and dexterity/opening process
Consumer panel tests
Human cognition/opening process
Design checklist
Conformance checklist

57. So!
Sell a System.
Not Just a Tablet,
Pill or Capsule
The Banks Do
It.
The
Supermarkets
Do It.
Why Can’t We?

58. Stephen Wilkins
CSPG