Web Application Security: Introduction to common classes of security flaws and testing methodologies
Design Flaws and Performance Testing - Standards Worldwide · Design Flaws and Performance Testing...
Transcript of Design Flaws and Performance Testing - Standards Worldwide · Design Flaws and Performance Testing...
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Design Flaws and Performance Testing
What are the most common or typical
failure modes in a packaging system, not
only the sterile barrier system but within
the entire packaging system?
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Accreditations & Certification & Membership
ISTA (International Safe Transit Association)
ISO9001:2008 Quality Management System
Independent ISO17025 Accreditation Test Laboratory
65 + International standards accredited
Accreditation & Certification
Anecto provide independent testing and
consulting service to worldwide companies in
the Medical Device industry in areas of
• Device Testing,
• Packaging
• Medical Electronics.
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Packaging Design Problem
• Packaging is seen as the poor relation in the majority of
projects
• It is not seen as a core item in a project or by companies
• It is seen as a necessary evil –
• And then the questions
– Where is the packaging?
– Did someone actually design the packaging?
Who was it? We need it now!
Nearly always an after thought
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The Initial Design
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Add a Little User Experience
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Design Pitfalls
• Incorrect box specification (product / intermediate / shipper)
– Incorrect or no Specification
• Typical Corrugated Box Specification
– Single wall corrugated board Kraft Liner / paper (Kraft outer as a
minimum)
» 150K/150T/150K - B Flute - Common/Medium Grade/Postal Grade
– Edge Crush Test (ECT) 44 minimum, Mullen Burst strength 275
– Stack height 270cm
– B or C flute or BC combined(Double Wall)
– Fluting orientation
• Does the product fit into the box?
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Design / Process Pitfalls
• Sealing Parameters • Only 1 sealing temperature / pressure / time verified
• Labelling badly defined • IFU / DFU not taken into consideration. Different
Languages not verified
• Definition of packaging design • Someone must design the packaging it doesn’t happen by itself
and it wont happen by committee
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• CONTAIN – To hold the product directly and indirectly; this is Primary and Secondary
Packaging.
– To present the product in a way that gets it to the user in the first place
– Allow ease of use
• INFORM
– To identify the brand, to explain how it should be used, to warn about the
hazards for misuse, and to reveal product contents.
– Present all necessary relevant information in clear & legible fashion
• PROTECT
– To prevent spoilage, leakage (Ingress or Egress), breakage, moisture changes,
theft or tampering.
– To protect the product to the point of use in the condition that means it is fit for
use
Five Purposes of Packaging
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• DISPLAY
– To attractively display, to sell (as a marketing tool).
– To present the product in the ‘best’ way for it’s user
– Size, cost, colours, brands, illustrations and shape are all considered for display.
– Present all necessary relevant information in clear & legible fashion
• TRANSPORT – To easily and safely move the product from the manufacturer, to a warehouse, to the
retailer and finally, to the point of consumption.
• Should be Defined in Packaging Project Plan
Five Purposes of Packaging
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Design Considerations
You Should Consider
– What are the User’s requirements
– Device requirements
– Packaging Material Selection
– Labelling requirements
– Sterilisation requirements
– Packaging equipment capabilities
– Distribution and storage requirements
– Expiry Date
– Financial considerations
– Have you met the User’s and Regulatory requirements
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Effect of Performance Testing
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Design Pitfalls
Incorrect material specification Glass transitioning temperature (Tg) for polymers
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Design Pitfalls
Shippers falling apart after Temperature /
Humidity exposure to environmental conditions
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Effects of Drop
Product protruding
through shipper
Shipper split along
manufacturers joint
even after packing
tape was applied by
customer
Corner damage and
Packaging tape broken Packaging Tape broken
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Effects of Drop
X40
magnification
X400
magnification
X100
magnification
X40
magnification
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Effects of Drop
Indentation from
folded internal pouch
Puncture from
internal product
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Effects of Vibration
Corner of IFU
punctured Pouch Puncture from
internal product
Internal product
causing indentations
After top loaded
vibration test
Fluting in the
incorrect direction
Intended shipping
orientation
(Fluting Horizontal)
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Compression
• Compressive Forces
– Warehousing / Storage (Static)
– Distribution (Dynamic)
• Degraded by Atmospheric Conditions
– Atmospheric Conditions
– Carton Manufacture
– Handling
– Ageing
• Significant Danger from Collapse
– (Personal Safety Issue)
Compression Strength – Safety Critical
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Typical Stacking Methods
Typical Colum stacked
pallet configuration
Cross stacked Pallet
configuration
Pin Wheel stacked Pallet
configuration
Typical brick built
stacked pallet
configuration
Typical split row
stacked pallet
configuration
A B C
D E
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Effect of Compression / Stack Test
Box incorrectly manufactured
resulted in corner being
pushed in when assembled
Result after
Compression / Stack
test
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Effect of Compression / Stack test
Product on Pallet
arriving for test
Product Punctured
foil pouch under
compression
200X magnification
Shipper box after
test
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Effects of Altitude
Shipper split along
joint due to internal
product packaging
expanding during
altitude test
Packaging Tape
broken due to
internal product
packaging
expanding during
altitude test
Product spilling out of
shipper after altitude test
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Transportation Testing Case Study
Validation of new packaging.
– Shippers passed Transportation test
– Product failed visual inspection and further product failed bubble leak testing.
Failure analysis
• The product was heavy and had come out of its snap fit and damaged the seals of the tray
• The product in the tray had sharp edges and had damaged the Tyvek
• Internal supports in the shipper were damaged
Root Cause and Analysis
The cardboard supports in the shipper had given way and allowed the product boxes to move excessively giving the product sufficient momentum to damage the seals and the Tyvek
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Package Design Fault
Image showing top view of box
after transportation testing
Image showing close-up view
of corner of box after
transportation testing
Package integrity test failed due to excessive movement of heavy product inside its tray
package which resulted in perforations of the Tyvek
Product
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Fibre in seal Sealed area less than 2mm Seal creep
Flaws Detected (F1886 visual inspection)
What To Look For
Over Sealed in closing seal Channel in seal Puncture in surface of pouch
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Metal Fatigue
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• Required seal What they got
– All samples were taken from the same seal location!!!?...! !!
Sealing Inconsistencies
What To Look For
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Which is the failure
All samples
were taken
from the
same seal
location?...!
All samples
were taken
from Tyvek and
clear film
pouches from
the same
process and lot
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• What happens when you
make the box too small
and / or the pouch too
big
Is It A Real Failure
Results of Design Decisions
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•Sheet Separation
•Bulk Density Reduction
Inter-laminar tension is
created (Red Arrows)
– Shear strength goes
down in the presence of
inter-laminar tension
At bend, thickness
compression
causes core
densification of
inner layers
Due to radius,
inner bonded
side bulges to
take up distance
Geometry is regular
and constrained far
away from bend – No
in-plane slippage
Sheet Separation (Delamination)
Is It A Real Failure
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Are You Sure You Designed it Correctly
This box had
travelled less than
80km and only
contained 2000
empty sterile plastic
vials!!!
Is this a good
DESIGN???!!!