european union (eu) package testing - healthpack · 1 european union (eu) package testing noel...
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![Page 1: European Union (EU) Package Testing - HealthPack · 1 European Union (EU) Package Testing Noel Gibbons. Quality Director. March 8 –10, 2011 Hyatt Regency Cincinnati, OH Anecto Ltd](https://reader031.vdocuments.mx/reader031/viewer/2022021717/5b3d73fb7f8b9a5e1f8dfd63/html5/thumbnails/1.jpg)
1
European Union (EU)
Package Testing
Noel Gibbons.
Quality Director.
March 8 – 10, 2011
Hyatt Regency
Cincinnati, OH
Anecto Ltd.
Galway,
Ireland.
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Who are Anecto?
Your Best Route to Europe
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3
Accreditations & Certification & Membership
ISTA (International Safe Transit Association)
ISO9001:2008 Quality Management System
ASTM International Organisation MemberVotes on Committee D10 and F02 Standards
ISO17025:2005 Test Laboratory Accreditation
50 + International standards accredited
Continuously adding new equipment and processes
Accreditation & Certification
ISO11607 Irish Committee -
Expert Member
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Services Provided by Anecto
• Reliability and Environmental Testing
• Validation of electronic equipment
• Process equipment validation
• Transportation / Package Testing
– Package Design Consultancy
– Test Process Analysis & Design Consultancy
• Package Integrity Testing (Including Visual Inspection)
• Catheter Burst testing
• Corrosion Testing on needles and stainless steel tubing
• High and Low Pressure testing
• Cold Chain / Temperature Mapping
• Design Support, Test Development (electronic)
• HALT & HASS
• Warranty, Repair & Support
• Dangerous Goods Package Testing
Your Best Route to Europe
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Product Specific Testing
• Mechanical Performance • Tensile and Micro Tensile
• Kink Resistance
• Torque
• Fatigue
• Fluid Dynamics
• High Pressure Injection Capability
• Static and Dynamic Catheter Burst testing
• Micro Flow and Leak Testing
• Catheter Dynamic Performance• Catheter Push, Track, Cross and Wire Movement
• Balloon Testing• Burst , Fatigue, Compliance, Inflation / Deflation, Balloon Wrapped Profile
• Dimensional Analysis• Length / Diameter, Lumen ID, Luers
• Deployment Accuracy, Foreshortening, „dog-boning‟, Unsupported Area
Your Best Route to Europe
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6
Test Failure!
6Your Best Route to Europe
Failures seen in packaging
performance testing and required
conformance to the EU/ISO11607-
1:2006 standard.
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Packaging – Often The Poor Relation
• Left until the end
• Seen as a necessary evil
• Sometimes there is Little or No Budget
• Not Seen as Value Add
• Conflict between marketing and manufacturing
Your Best Route to Europe
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Risks!
• Every processes or product has associated risks– Process
– Packaging
– Handling
– Transportation / Distribution
– Storage
– Integrity
– Altitude
– Global Distribution location
• Risk factors must be assessed to determine
when and why failures may occur
Your Best Route to Europe
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Testing Questions
From your Risk assessment you will be able to determine
• How much testing should be done?
• What tests are needed?
– Transportation Testing
– Integrity Testing
– Seal Strength testing
– Stability studies
• How many samples are needed?
• Is Accelerated and Real time Ageing needed?
Your Best Route to Europe
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ISO 11607:2006 List of Tests
• Accelerated aging ASTM F1980, EN 868-8
• Air permeance ISO 5636-2, ISO 5636-3, ISO 5636-5,
EN 868-2, ASTM D 737
• Basis weight ISO 536, ASTM D4321,ASTM D3776
• Biocompatibility ISO 10993-1
• Burst strength ISO 2758
• Cleanliness TAPPI T 437-OM-96
• Chlorides ISO 9197
• Coat weight ASTM F 2217
• Conditioning ISO 187, ASTM D4332, ISO 2233
• Dimensions ASTM F2203
• Drapability ISO 9073-9, ISO 2493, DIN 53121
• Flexural durability ASTM F392
• Gas sensing ASTM F2228
• Integrity ASTM F1929, ASTM F2227
• Internal pressure ASTM F2096
• Low-tension surface liquid resistance IST 80-8
• Microbial barrier ASTM F1608, DIN 58953-6, BS 6256,
ASTM F2101,SS 876 0019
• Peel-open characteristic EN 868-5
• Performance testing ASTM D4169, ISTA 1,2, and 3, ISO 4180-1,EN 868-8
• pH ISO 6588-1, ISO 6588-2
• Pressure leak ASTM F2338
• Printing and coating ASTM F2250, ASTM F2252
• Puncture ASTM D1709, ASTM F1306, ASTM D3420
• Seal strength ASTM F88, ASTM F1140, ASTM F2054, EN 868-5
• Static electricity BS 6524
• Sulfates ISO 9198
• Tear resistance ASTM D1922, ASTM D1938, ISO 1974
• Tensile properties ISO 1924-2, ASTM D882
• Thickness / Density ISO 534, ASTM D645, ASTM F2251
• Vacuum leak ASTM D3078, EN 868-8
• Visual inspection ASTM F1886, EN 868-8
• Water resistance ISO 811, EDANA 170-1, ASTM D779, EN 20535
• Wet burst in wet condition ISO 3689
• Wet tensile properties ISO 3781
71 test standards covering 34 types of test
Which Standard
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How Much Testing?
Production
Packages
Sterilisation
Distribution
Simulation
T0 Base
Line Testing
Package
Integrity
Tests
Physical
Strength
Tests
Package
Integrity
Tests
Physical
Strength
TestsT0 Test
Report
Real Time
Ageing
Testing
1 year
Real Time.
Ageing
3 year
Real Time.
Ageing
Package
Integrity
Tests
Physical
Strength
Tests
Package
Integrity
Tests
Physical
Strength
Tests
1 yr Real
Time Ageing
Test Report
3 yr Real
Time Ageing
Test Report
Package
Integrity
Tests
Physical
Strength
Tests
Accelerated
Ageing
Testing
1 year
Accelerated
Ageing
3 year
Accelerated
Ageing
1 yr Accel
Ageing Test
Report
3 yr Accel
Ageing Test
Report
DQ IQ OQ PQ
Package
Integrity
Tests
Physical
Strength
Tests
Test Report
Physical
Strength
Tests
Package
Integrity
Tests
3 separate lots
required for PQ
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Where do you look for failures?
Real Time
Ageing
Testing
Accelerated
Ageing
Testing
2 year
Accelerated
Ageing
3 year
Accelerated
Ageing
T0 Test
Report
Package
Integrity
Tests
Physical
Strength
Tests
T0 Base Line
Testing
Package
Integrity
Tests
Physical
Strength
Tests
Distribution
Simulation
Distribution
Simulation
Package
Integrity
Tests
Physical
Strength
Tests
Test Report
3 year
Real Time.
AgeingPackage
Integrity
Tests
Physical
Strength
Tests
1 yr Accel
Ageing
Reports
2 yr Accel
Ageing
Reports
3 yr Accel
Ageing
Reports
Production
Packages
Sterilisation
Distribution
Simulation
Distribution
Simulation
Distribution
Simulation
Distribution
Simulation
Distribution
Simulation
Package
Integrity
Tests
Physical
Strength
Tests
1 yr Real
Time Ageing
Reports
2 yr Real
Time Ageing
Reports
3 yr Real
Time Ageing
Reports
1 year
Accelerated
Ageing
1 year
Real Time.
Ageing
2 year
Real Time.
Ageing
DQ IQ OQ PQ
Distribution
Simulation Test Report
Test Report
Physical
Strength
Tests
Package
Integrity
Tests
Your Best Route to Europe
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What Causes Packaging Failures?
• Have you asked the relevant questions on the
purpose of your packaging?
– What are you packaging?
– What is the value of the product?
– What type of packaging is required (shelf or display)?
– Where is the product being sold?
– What standards must the packaging meet?
– What is the marketing plan for the product?
Are there any other considerations?
Your Best Route to Europe
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Why Failures Occur?
– Device requirements not defined!
– Packaging Material Selection not defined!
– Sealing Parameters not defined!
– Labelling requirements not defined!
– Sterilisation requirements not defined!
– Packaging equipment capabilities not defined!
– Distribution and storage requirements not defined!
– Expiry Date not defined!
Your Best Route to Europe
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Stress Exceeds Strength => Failure
Why Products Fail?
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Stress Exceeds Strength => Failure
Why Products Fail?
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Examples of Failure
17Your Best Route to Europe
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Sample Size Failure
• What is the correct sample size?
– How do you calculate your sample size for your product?
– How many for Transportation test, Ageing, Integrity, Strength?
– What is your acceptable pass / fail rate 0, 1, 2, 3……?
• Failure Due to small Sample Size
– Reject by regulatory body due to a sample size as follows
• 1 Partially filled shipper for transportation testing
– Normal filled shipper 20 units only 14 units in the shipper
• 7 pouches for strength testing
• 5 pouches used for integrity testing
• 2 returned to customer for functional testing
Your Best Route to Europe
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Spotty Seals
Lo
w a
larm
lim
it
Pro
ce
ss
Fa
ilu
re
(x%
Sp
ott
ine
ss)
Lo
w S
pe
c lim
it
Nominal
Settings for
Temperature
Pressure and
Time Up
pe
r S
pe
c lim
it
Up
pe
r a
larm
lim
it
Pro
ce
ss
Fa
ilu
re
(x%
Tra
nsp
are
nt)
Optimum Range
Glazed Tyvek
100% seal Transfer (no spots, no glazing)
Heat Sealing Process
Define Acceptance Criteria
Evaluating your sealing process
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1- Reject
2 2
3 3
4 4
5
Reject - 1
Seal
Quality
Score
Visual Characteristics
A
C
C
E
P
T
A
C
C
E
P
T
Under
sealed
slope
Over
sealed
slope
Visual Characteristic Rating Scale
5 – Acceptable- Package meets highest visual requirements
2 to 4 – Acceptable- Package meets seal requirements
Under sealed
Over sealed
1 – Rejectable- Package seal does not meet minimum requirements
Visual Inspection Attribute Qualification
R
E
J
E
C
T
R
E
J
E
C
T
Define Acceptance Criteria
Have you set your Accept / Reject level for your sealing process
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Visual Inspection Criteria for Packaging
What To Look For
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Fibre in seal Sealed area less than 2mm Seal creep
Visual Inspection Failures
What To Look For
Over Sealed in closing seal Channel in seal Puncture in surface of pouch
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Visual Inspection Failures
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Labelling Failures
• Labelling system failures
– Torn or illegible
– Not compatible with
• the materials,
• sterile barrier system or
• medical device
– adversely affect the sterilisation process due to size and location
– Peels off or fades during the sterilisation process
– Incorrect ink / printer ribbon used print rubs off
– Glues damage the packaging material
– colour change making the label illegible.
Your Best Route to Europe
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Typical Label Failures
Human readable
text worn away
Barcode rubbed
away
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Sterilisation Compatibility for Various Materials
* Under controlled conditions -industrial at 121°C max for 20 minutes
Sterilisation method must be Compatible with the labelling
• Package must retain adequate permeability if it is to be sterilised using
EtO, Steam or Oxidation / Plasma type processes
• Package Must not transfer anything to the device
Gamma Radiation
Steam*
Electron Beam
Low Temp Oxidation
EtO
Paper
Yes
Yes
Yes
No
Yes
Tyvek
Yes
Yes
Yes
Yes
Yes
Film
No
No
Yes
No
Yes
Foil
No
No
Yes
No
Yes
Plastic
No
No
Yes
No
Yes
Your Best Route to Europe
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Steam Sterilisation Failure
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Transportation Test Failure
28Your Best Route to Europe
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Atmospheric Conditions
• What is the glass transitioning point (Tg) of my product and
packaging?
• Will the packaging survive a world wide conditioning
sequence?
– Failure Modes
• Changes in Physical Properties
• Insulation Degradation
• Seals / Glue Joints
Atmospheric Conditions Degrade Packaging
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Atmospheric failures
Your Best Route to Europe
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Shock / Drop
Shock Damages Product & Perception
Damage to Product & Packaging
– Cosmetic & Functional Failures
• If You Can Lift It, You Can Drop It!
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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 brokenPackaging Tape broken
Your Best Route to Europe
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Effects of Drop
X40
magnification
X400
magnification
X100
magnification
X40
magnification
Your Best Route to Europe
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Effects of Vibration
Corner of IFU
punctured PouchPuncture from
internal product
Internal product
causing indentations
After top loaded
vibration test
Your Best Route to Europe
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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
Your Best Route to Europe
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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
Your Best Route to Europe
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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
Your Best Route to Europe
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Effects of Concentrated Impact Test
Hole Through shipper after test
Pass / Fail ?Indentation on shipper after test
Pass / Fail ?
Indentation on Pouch after test
Your Best Route to Europe
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39
Transportation Testing Case Study
Medical device company asked Anecto to validate their new packaging prior to submission of 510K.
– 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
Your Best Route to Europe
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41
Medical device company asked Anecto to validate their new packaging prior to
submission of 510K.
– Shippers passed Transportation test
– Product failed visual inspection and further product failed bubble leak testing.
Failure analysis
There were transparent areas in the surface of the Tyvek and a number of impact
holes in some of the pouches
Root Cause and Analysis
There were 40 Tyvek and clear film pouched products in the shipper.
– These were layered either clear film to Tyvek or Tyvek to Tyvek
When the product was vibrated the pouches rubbed off each other.
– A hard edge on the product rubbed against the Tyvek causing a week spot
– When the shipper was dropped the hard edge punctured the weakened Tyvek area
Transportation Testing Case Study
Your Best Route to Europe
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42
Transportation Testing Case Study
Medical device manufacturer updated their display boxes to improve
the look of their shelf product but had complaints from outlets due to
scuffing / scratching on the new display boxes.
Standard ISTA 2A Vibration test
Vibration test on product inspected and packed in Anecto
Passed all standard tests with no scuffing on new or old box
Repeat of ISTA 2A vibration test on standard packaging straight from factory floor Failed boxes scuffed on new boxes only
Repeat of ISTA 2A vibration test with the addition of standard packaging / process dust from the factory warehouse
Failed boxes scuffed on new boxes only
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Failure analysisAnalysis of the board used on the new box showed that the external
lacquer that had been used on the old box had not been applied to
the new box allowing the ink to scuff.
Costs
Cost to Supplier approx €10,000 for boxes that were rejected,
including cost of testing plus cost of down time………..
Conclusion
If the company had carried out specification testing on a sample of
the new box before going into production the problem would have
been discovered at an early stage.
Transportation Testing Case Study
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Integrity and Strength Test
Failure
44Your Best Route to Europe
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45Which Method
Peel Test Fixture Methods
In Europe 900 with 15mm samples are most commonly used
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• “Suppliers” seal? vs. “In-house” seal?
– If in-house seal is not set up properly, welding of the pouch material
may occur at the seal.
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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• Dye Test: ASTM F1929, EN868
– Challenges heat seal for evidence of
channels or inclusions that create a
torturous path
ASTM F1929 Dye Penetration
Evidence of Failure
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• Sheet Separation of Tyvek
(Delamination)
• Bulk Density Reduction
– Follow-up with a Dye Test for
validation
Is It A Real Failure
Subjective Failures (False Positive?)
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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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Package Integrity Case Study
Customer requested as part of their product / packaging process validation
that Anecto carry out bubble leak test as part of a suit of tests including
Dye Penetration test and Peal Test prior to submission to FDA.
Standard Inspection Test ASTM F1886 Passed
Standard Bubble Leak Test ASTM F2096 5 pouches Failed
Failure analysis
The 5 pouches failed due to holes / cuts in the surface of the clear film.
The Pouches had gone through the manufacturers standard process. All
machines were checked with no issues found.
A sample of product was re-run and the product tested again.
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Package Integrity Case Study
Re-test results
3 of the 12 pouches failed again for the same failure
Root Cause and Analysis
There was an extra bench added to the inspection area. When the bench
was assembled 2 of the screws that were used were too long and came
through the top surface less than half a millimeter.
When the pouches were moved along the bench………….
Conclusion
If you change anything in your process you need to validate that it will not
have an impact on your product or its sterility.
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53
Cold Chain Failure
53Your Best Route to Europe
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Typical Cold Chain Conditioning
Temperature Map
-20.00
-15.00
-10.00
-5.00
0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
40.00
45.00
50.00
0.00
2.00
4.00
6.00
8.00
10.0
0
12.0
0
14.0
0
16.0
0
18.0
0
20.0
0
22.0
0
24.0
0
26.0
0
28.0
0
30.0
0
32.0
0
34.0
0
36.0
0
38.0
0
40.0
0
42.0
0
44.0
0
46.0
0
48.0
0
50.0
0
52.0
0
54.0
0
56.0
0
58.0
0
60.0
0
62.0
0
64.0
0
66.0
0
Time (Hours)
Tem
per
atu
re
ANO1193
ANO1152
ANO1192
ANO1249
Ambient
ANO1250
ANO1178
Limit
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How long will it LastMax Vol Min Load
-80.00
-75.00
-70.00
-65.00
-60.00
-55.00
-50.00
-45.00
-40.00
-35.00
-30.00
-25.00
-20.00
-15.00
-10.00
-5.00
0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
40.00
45.00
Tim
e
2.6
5.3
7.9
10.6
13.3
15.9
18.6
21.3
23.9
26.6
29.3
31.9
34.6
37.3
39.9
42.6
45.3
47.9
50.6
53.3
55.9
58.6
61.3
63.9
66.6
69.3
71.9
74.6
77.3
79.9
82.6
85.3
87.9
90.6
93.3
95.9
Time
Tem
pera
ture
(C)
Hot spots in
packaging
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What will be discoveredMin Load
-85.0
-80.0
-75.0
-70.0
-65.0
-60.0
-55.0
-50.0
-45.0
-40.0
-35.0
-30.0
-25.0
-20.0
-15.0
-10.0
-5.0
0.0
5.0
10.0
15.0
20.0
25.0
30.0
Time 74.42 76.92 79.42 81.92 84.42 86.92 89.42 91.92 94.42 96.92 99.50 102.00 104.50 107.00 109.50 112.00 114.50 117.00 119.50
Te
mp
era
ture
(C
)
Hot spots in
packaging
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The most expensive product is the one that is
rejected by the customer or stops working after
a short period of time
• Recall / retrofit often leads to loss of reputation
• Scraping of damaged Product / Packaging
• Customer satisfaction
• Loss to competition
You must remember the name on the package is
your company name
Product Ownership
Who Owns The Product
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Testing is Global
• Testing is globally the same provided
– You are all using the same international standard
– Your equipment meets the requirement of the standard
– Your test people understand the standard
– Your people are sufficiently trained
The products may vary along with the documentation
• 75% of the Top Global Medical Device Companies
world wide use our services in Europe
Your Best Route to Europe
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Do You have the Correct Packaging
This box had
travelled less
than 80km and
only contained
2000 empty
sterile plastic
vials!!!
One test is worth a thousand expert opinions
Your Best Route to Europe