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Non‐Destructive Package Testing:Driving Sustainable Operations
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Overview
• Sustainability• True Cost of Destructive Testing• Six Sigma Perspective• Cost Effective Solutions
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Package Integrity
• Package integrity – the ability to maintain a sterile barrier.
• Package integrity is a sub‐category of quality and is exclusive of:
Peel StrengthBurst TestingVisual Inspection
Package Quality
Package Integrity
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Environmental Perspective
Minimal impact on the environment, reducing resource consumption and waste.
Operational Perspective
Operate today without compromising tomorrow.
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Two Main Goals:
Eliminate WasteImprove Quality
Non‐Destructive TestingTwo birds with one stone.
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Common MethodWater Bath ‐ Bubble Leak Test
• Water Bath – Flexible Barrier Systems• Moisture/Flavor critical defect size – 15
microns• Water bath sensitive to 25‐50 microns• Typically test 20 pouches/line/hour• Current market price of coffee > $2.00/lb
ASTM F2096‐04
0
50
100
150
200
250
Jan‐09
Apr‐09
Jul‐0
9
Oct‐09
Jan‐10
Apr‐10
Jul‐1
0
Oct‐10
Jan‐11
Apr‐11
Jul‐1
1
cents/lb
Green Coffee Wholesale Prices
www.ico.org
20 x 1 x $2 x 24 x 7 x 52 x 0.5 = $174,720
Bags Tested 1lb Bags $/lb Hours, Days, Weeks Up‐Time
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Common Method02 Head Space Analysis
• 6 day dwell. • 3% pass/fail limit.• 50 micron defect 700 gr. dry fill pouch.• O2 shifted from ~1% to ~2.5%.
$4.41/kg
http://future.aae.wisc.edu
ppm Up‐Time Minutes, Hours, DaysUnits
60 x .5 x 60 x 24 x 6 = 259,200kg/unit Cost/kg
259,200 x .7 x $4.41 = $800,150
ASTM F2714‐08
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0
10
20
30
40
50
60
70
80
90
100
10 20 30 40 50 60 70 80 90
Time on Task, min
Prob
ability of D
etection
Drury & Watson, 2002
Manual Visual Inspection
80%
80%
80%
80%
Channel leaks down to “75 μm [0.003 in.] with a 60–100 % probability”1.
Assumptions1,000 Packs/Day 1% Defect Rate10 Defects/Day ~2,500 Defects Per Year80% POD (Above Average)
100% Inspection = 500 Defects/Year200% Inspection = 100 Defects/Year
400% Inspection (4 Operators)4 Undetected Defects/Year0.16% probability that a defect will go undetected.
1http://www.astm.org/Standards/F1886.htm
ASTM F1886
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Non‐Destructive is Cost EffectiveProduct Cost of
Raw Materials
Quantity Tested
Frequency Cost/8 Hour Shift
Cost/Year(2 Shifts, 250 Days)
Dry Fill Soup Mix
$0.23 8 Every 30 min.
$29.44 $14,720
Effervescent Tablets
$0.04 80 Every 30 min.
$51.20 $25,600
Coffee Singles Pod
$0.06 200 Every Hour $96 $48,000
Luer‐LokSyringe
$0.20 50 Every 30 min.
$160 $80,000
PharmaBlister Pack
$1.12 10 Every 30 min.
$179.20 $89,600
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Consider Better Alternatives
• Non‐Destructive vs. Destructive• Quantitative vs. Attribute • Non‐Subjective vs. Operator Dependent• Calibration Capability • Validation Effectiveness• Simple Methodology (no sample prep)
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Six Sigma Framework ‐ DMAIC
DefineMeasure
AnalyzeImprove
Control
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Foundation of Quality Control
DefineQuality cannot be controlled without discrete and measurable characterizations of quality.
MeasureQuality cannot be controlled without accurate and definitive measures of quality.
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How is Quality Defined?
Good Bad
Visual Physical
What gray area definitions pervade your operation?
D M A I C
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Common Approaches to Defining Package Integrity
• “Looks good”• Capability (Best Available Technology)• Equal to/Better than• Third Party White Papers• Grandfathered Industry Standards• “Critical, Major, Minor”
D M A I C
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Visual
Physical
Physical Leak/Contamination
No Physical Leak/No Contamination
Visually DefectiveVisually O.K.
D M A I C
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Visual
Physical
Physical Leak/Contamination
No Physical Leak/No Contamination
Visually DefectiveVisually O.K.
D M A I C
Major
Minor
Critical Critical
Codify Quality
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Develop measurable definitions.
D M A I C
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Measuring Quality
• Industry Standards (ASTM, ISO)• Manual Visual Inspection• Grandfathered Methods• Implied Quality Measures
Visual Physical
D M A I C
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Know Your Package Physics
• Blue dye ingress works for rigid and semi‐rigid packaging, NOT flexible packaging.
• Water bath bubble leak test requires that vacuum be pulled to a point beyond the maximum expansion of your package.
P1V1 = P2V2 = P3V3
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Direct Measures of QualityISO 11607 – Annex B
• Vacuum Decay (ASTM F2338)• Seal Strength (ASTM F88)• Airborne Ultrasound Seal Inspection*• Visual Inspection (ASTM F1886)• Dye Migration (F1929)• High Voltage Leak Detection*• Burst Strength (ASTM F2054)• Bubble Immersion (ASTM F2096, D3078)
D M A I C
* Not listed in ISO 11607 or ASTM
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Non‐Subjective, QuantitativeD M A I C
• Vacuum Decay (ASTM F2338)• Seal Strength (ASTM F88)• Airborne Ultrasound Seal Inspection
• High Voltage Leak Detection• Burst Strength (ASTM F2054)
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Non‐Destructive D M A I C
• Vacuum Decay (ASTM F2338)
• Airborne Ultrasound Seal Inspection
• High Voltage Leak Detection
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Quantitative Measures Provide Greater Access to Statistical Tools
• Ultrasonic Attenuation• Thickness• Peel Strength• Permeation• Leak Rate
Attribute data fails to produce predictive measures of quality.
D M A I C
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Capability Approach vs. Critical Requirement
100% On‐Line Off‐line SPC
On‐lineSqueeze Tester
Vision System On‐lineVacuum Decay
HVLD
Off‐Line Vacuum Decay Helium
Sniffing02 Sniffing
HVLD
D M A I C
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Improve
Gray Measures Gray Responses
D M A I C
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Control
The final stage of the D M A I C process.
D M A I C
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Vacuum Decay Leak Testing
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Vacuum Decay Test MethodASTM F2338‐09
0
2
4
6
8
10
12
14
16
18
20
0
100
200
300
400
500
600
0 1 2 3 4 5 6 7 8 9 10
Differen
tial Pressure, Pa/sec
(Secon
dary Transdu
cer)
Vacuum
Level Below
Atmosph
eric Pressure, m
b
Test Cycle
Test Cycle Pass
Test Cycle Fail
dP Pass
dP Fail
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Vacuum Decay for Flexible Packaging
TEST PARAMETERSTStroke 1.50TEqual 20.00
Vac. 700.2 TTest 5.00Vacuum, mb dP/dt, Pa/s TFill, s
Ref 450.2 35.2 15.00
Test # Vacuum, mb dP/dt, Pa/s Pass/Fail Comments
1 644.8 27.3 P Good Product2 639.3 27.3 P Good Product3 635.7 26.7 P Good Product4 638.0 25.7 P Good Product5 633.7 26.7 P Good Product6 586.6 95.4 F 25 micron7 576.8 90.5 F 25 micron8 638.0 56.6 F 15 micron9 634.7 52.4 F 15 micron10 636.0 40.4 F 10 micron11 641.6 39.4 F 10 micron
ASTM F2338‐09
0
5
10
15
20
0
100
200
300
400
500
600
0 1 2 3 4 5 6 7 8 9 10
Differen
tial Pressure, Pa/sec
(Secon
dary Transdu
cer)
Vacuum
Level Below
Atmosph
eric Pressure, m
b
Test Cycle
Test Cycle Pass
Test Cycle Fail
dP Pass
dP Fail
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Vacuum Decay Applications
• Hermetically Sealed Packaging(Flexible, Rigid, Semi‐Rigid)
• Tyvek® Lidded Trays• Components & Fixtures
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Vacuum Decay Summary
• Dye Ingress• “Thumb Test”/Visual• Bubble Leak Test
Subjective Results One Chance to Observe Costly Long Term
• Simple/No Package Preparation• Quantitative Results• Repeatable• Non‐Subjective• Zero Waste
Vacuum Decay
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Airborne Ultrasound Through Transmission
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Ultrasonic Signal
Propagate through single or multiple layers of well bonded materials.
Reflection/absorption of sound waves by multiple layers.
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Seal‐Scan® Online Pouch Seal Inspection
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Optimizing the Sealing Process
-100.0
-80.0
-60.0
-40.0
-20.0
0.0
20.0
40.0
60.0
80.0
100.0
100 110 120 130 140 150 160 170 180 190
Temperature at Which Pouch is Sealed
Sign
al V
alue
MaxMin
As the the temperature at which the seal is created increases, the maximum signal values are not affected. However, the minimum values experienced increase with higher temperatures, producing optimum seals at 160 and 180.
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Mass Pressure Analysis (g/cm2)
y = ‐28.06ln(x) ‐ 117.06
‐50.00
‐40.00
‐30.00
‐20.00
‐10.00
0.00
10.00
20.00
30.00
40.00
50.00
0.0000 0.0100 0.0200 0.0300 0.0400 0.0500 0.0600 0.0700Avg, %
t*ru, g/cm2
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Seal‐Scan® and Peel Strength Testing
R2 = 0.7895
R2 = 0.833
4
5
6
7
8
9
10
5 7 9 11 13 15 17 19
Ultrasonic Standard Deviation
Peel
Str
engt
h A
vera
ge L
oad
(N)
Avg LoadMaximum LoadLinear (Avg Load)Linear (Maximum Load)
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Airborne Ultrasound Applications
• Seal Inspection • Materials Analysis• Flexible and Semi‐Rigid Packaging• On‐line defect detection• Off‐line seal analysis• Ideal for porous flexible packaging.
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Ultrasound Summary
• Non‐destructive• Quantitative• Optimize Process• Characterize Materials• On‐Line Capability• Traceable Standards• Analyze, Improve, Control
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High Voltage Leak Detection(HVLD)
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HVLD Defect Detection for Pouches
• Micro leaks down to 5 microns• Pinholes• Cracks• Crystallized leaks• Channel defects
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HVLD Technology
• High voltage applied to container
• Ideally non‐conductive materials
• Liquid triggers conductivity spike
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HVLD Online Pouch Inspection
Designated electrode design for critical ports and welds.
Size Capacity
100~1,000 ml 6,000/ bags hr.
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HVLD Detection
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HVLD Applications
• Non‐porous, Non‐conductive• Package Contents: ‐ liquid products ‐ protein based liquids‐ suspensions or emulsions
• Flexible or Rigid Barrier
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HVLD Summary
• High Speed 100% On‐line• Liquid Fill Packaging• Targeted Inspection• Quantitative• Detects Critical to Quality Defects
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Two Main Goals:
Eliminate WasteImprove Quality
Non‐Destructive TestingTwo birds with one stone.
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The Ideal Test Method
InformativeAccurateSimpleCost Effective
Reduces WasteIncreases Productivity
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Six Sigma Framework
DefineMeasure
AnalyzeImprove
Control
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Thank You!Oliver [email protected]