1

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?

2

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.

3

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

4

The Initial Design

5

Add a Little User Experience

6

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?

7

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

11

Effect of Performance Testing

11

12

Design Pitfalls

Incorrect material specification Glass transitioning temperature (Tg) for polymers

13

Design Pitfalls

Shippers falling apart after Temperature /

Humidity exposure to environmental conditions

14

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

15

Effects of Drop

X40

magnification

X400

magnification

X100

magnification

X40

magnification

16

Effects of Drop

Indentation from

folded internal pouch

Puncture from

internal product

17

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)

18

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

19

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

20

Effect of Compression / Stack Test

Box incorrectly manufactured

resulted in corner being

pushed in when assembled

Result after

Compression / Stack

test

21

Effect of Compression / Stack test

Product on Pallet

arriving for test

Product Punctured

foil pouch under

compression

200X magnification

Shipper box after

test

22

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

23

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

24

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

25

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

29

• 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

31

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???!!!