Performance Testing What are the most common or typical failure - - PowerPoint PPT Presentation

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Design Flaws and Performance Testing

What are the most common or typical failure modes in a packaging system, not

• nly 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

• rientation

(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

• f 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???!!!