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

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? 1

Accreditations & Certification & Membership Independent ISO17025 Accreditation Test Laboratory 65 + International standards accredited ISO9001:2008 Quality Management System ISTA (International Safe Transit Association) Anecto provide independent testing and consulting service to worldwide companies in the Medical Device industry in areas of • Device Testing, • Packaging • Medical Electronics. Accreditation & Certification 2

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 – We need it now! Who was it? Nearly always an after thought • And then the questions – Where is the packaging? – Did someone actually design the packaging? 3

The Initial Design 4

Add a Little User Experience 5

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? 6

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 7

Five Purposes of Packaging • 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 8

Five Purposes of Packaging • 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 9

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 10

Effect of Performance Testing 11 11

Design Pitfalls Incorrect material specification Glass transitioning temperature (Tg) for polymers 12

Design Pitfalls Shippers falling apart after Temperature / Humidity exposure to environmental conditions 13

Effects of Drop Shipper split along Product protruding manufacturers joint through shipper even after packing tape was applied by customer Corner damage and Packaging Tape broken Packaging tape broken 14

Effects of Drop X400 X40 magnification magnification X40 X100 magnification magnification 15

Effects of Drop Puncture from internal product Indentation from folded internal pouch 16

Effects of Vibration Corner of IFU Puncture from Internal product punctured Pouch internal product causing indentations After top loaded Intended shipping vibration test orientation Fluting in the (Fluting Horizontal) incorrect direction 17

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 18

Typical Stacking Methods A B C Cross stacked Pallet Typical Colum stacked Pin Wheel stacked Pallet pallet configuration configuration configuration D E Typical brick built Typical split row stacked pallet stacked pallet configuration configuration 19

Effect of Compression / Stack Test Box incorrectly manufactured resulted in corner being pushed in when assembled Result after Compression / Stack test 20

Effect of Compression / Stack test Product Punctured foil pouch under compression 200X magnification Product on Pallet Shipper box after arriving for test test 21

Effects of Altitude Shipper split along joint due to internal product packaging expanding during altitude test Packaging Tape Product spilling out of broken due to shipper after altitude test internal product packaging expanding during altitude test 22

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 23

Package Design Fault Product Image showing close-up view Image showing top view of box of corner of box after after transportation testing transportation testing Package integrity test failed due to excessive movement of heavy product inside its tray package which resulted in perforations of the Tyvek 24

Flaws Detected (F1886 visual inspection) Fibre in seal Seal creep Sealed area less than 2mm Channel in seal Over Sealed in closing seal Puncture in surface of pouch What To Look For 25

Metal Fatigue 26

Sealing Inconsistencies • Required seal What they got – All samples were taken from the same seal location!!!?...! !! What To Look For 27

Which is the failure All samples All samples were taken were taken from the from Tyvek and same seal clear film location?...! pouches from the same process and lot 28

Results of Design Decisions • What happens when you make the box too small and / or the pouch too big Is It A Real Failure 29

Sheet Separation (Delamination) • Sheet Separation • Bulk Density Reduction At bend, thickness compression causes core Due to radius, densification of inner bonded inner layers side bulges to take up distance Inter-laminar tension is Geometry is regular created (Red Arrows) and constrained far – Shear strength goes away from bend – No down in the presence of in-plane slippage inter-laminar tension Is It A Real Failure 30

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???!!! 31