Non‐Destructive Package Testing: Driving Sustainable Operations Overview

• Sustainability • True Cost of • Six Sigma Perspective • Cost Effective Solutions Package Integrity

• Package integrity –the ability to maintain a sterile barrier. • Package integrity is a sub‐ Package Package category of quality and is Integrity Quality exclusive of: Peel Strength Burst Testing Visual Inspection Environmental Perspective Minimal on the environment, reducing resource consumption and waste.

Operational Perspective Operate today without compromising tomorrow. Two Main Goals:

Eliminate Waste Improve Quality

Non‐Destructive Testing Two birds with one stone. Common Method Water Bath ‐ Bubble Leak Test ASTM F2096‐04

• Water Bath –Flexible Barrier Systems Green Coffee Wholesale Prices • Moisture/Flavor critical defect size –15 250 microns 200 • Water bath sensitive to 25‐50 microns 150 100 cents/lb • Typically test 20 pouches/line/hour 50 • Current market price of coffee > $2.00/lb 0 09 10 11 ‐09 ‐10 ‐11 ‐ ‐ ‐ ‐09 ‐10 ‐09 ‐10 ‐11 Jul Jul Jul Jan Jan Jan Oct Oct Apr Apr Apr www.ico.org

Bags Tested 1lb $/lb Hours, Days, Weeks Up‐Time 20 x 1 x $2 x 24 x 7 x 52 x 0.5 = $174,720 Common Method ASTM F2714‐08 02 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%. http://future.aae.wi Units sc.edu ppm Up‐Time Minutes, Hours, Days $4.41/kg 60 x .5 x 60 x 24 x 6 = 259,200

kg/unit Cost/kg 259,200 x .7 x $4.41 = $800,150 Manual Visual Inspection ASTM F1886

 Channel leaks down to “75 μm [0.003 in.] with a 60–100 % probability”1.

80% Assumptions 80% 1,000 Packs/Day 1% Defect Rate 80% 10 Defects/Day ~2,500 Defects Per Year 80% POD (Above Average) 80%

100 100% Inspection = 500 Defects/Year 90 80 200% Inspection = 100 Defects/Year 70

Detection 60 of 50 400% Inspection (4 Operators) 40 30 4 Undetected Defects/Year 20 Probability 10 0.16% probability that a defect will go undetected. 0 10 20 30 40 50 60 70 80 90 Time on Task, min Drury & Watson, 2002 1http://www.astm.org/Standards/F1886.htm Non‐Destructive is Cost Effective

Product Cost of Quantity Frequency Cost/8 Cost/Year Raw Tested Hour Shift (2 Shifts, 250 Days) Materials Dry Fill Soup $0.23 8 Every 30 $29.44 $14,720 Mix min. Effervescent $0.04 80 Every 30 $51.20 $25,600 Tablets min. Coffee $0.06 200 Every Hour $96 $48,000 Singles Pod Luer‐Lok $0.20 50 Every 30 $160 $80,000 Syringe min. Pharma $1.12 10 Every 30 $179.20 $89,600 min. Consider Better Alternatives

• Non‐Destructive vs. Destructive • Quantitative vs. Attribute • Non‐Subjective vs. Operator Dependent • Calibration Capability • Validation Effectiveness • Simple Methodology (no sample prep) Six Sigma Framework ‐ DMAIC

Define Measure Analyze Improve Control Foundation of Quality Control

Define Quality cannot be controlled without discrete and measurable characterizations of quality. Measure Quality cannot be controlled without accurate and definitive measures of quality. D M A I C How is Quality Defined?

Good Bad

Visual Physical

What gray area definitions pervade your operation? Common Approaches D M A I C to Defining Package Integrity

• “Looks good” • Capability (Best Available Technology) • Equal to/Better than • Third Party White • Grandfathered Industry Standards • “Critical, Major, Minor” D M A I C Visual Visually O.K. Visually Defective

No Physical Leak/ No Contamination

Physical

Physical Leak/ Contamination D M A I C Codify Quality Visual Visually O.K. Visually Defective

No Physical Leak/ Major No Contamination Minor Physical

Physical Leak/ Contamination Critical Critical D M A I C

Develop measurable definitions. D M A I C Measuring Quality

• Industry Standards (ASTM, ISO) • Manual Visual Inspection • Grandfathered Methods • Implied Quality Measures

Visual Physical 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 D M A I C Direct Measures of Quality ISO 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) * Not listed in ISO 11607 or ASTM D M A I C Non‐Subjective, Quantitative

• Vacuum Decay (ASTM F2338) • Seal Strength (ASTM F88) • Airborne Ultrasound Seal Inspection

• High Voltage Leak Detection • Burst Strength (ASTM F2054) D M A I C Non‐Destructive

• Vacuum Decay (ASTM F2338)

• Airborne Ultrasound Seal Inspection

• High Voltage Leak Detection Quantitative Measures Provide D M A I C Greater Access to Statistical Tools

• Ultrasonic Attenuation • Thickness • Peel Strength • • Leak Rate

Attribute fails to produce predictive measures of quality. D M A I C Capability Approach vs. Critical Requirement

100% On‐Line Off‐line SPC

On‐line Off‐Line Vision System Helium Vacuum Decay Vacuum Decay Sniffing On‐line HVLD 02 Sniffing Squeeze Tester HVLD D M A I C Improve

Gray Measures  Gray Responses D M A I C Control

The final stage of the D M A I C process. Vacuum Decay Leak Testing ASTM F2338‐09 Vacuum Decay

600 20

18 500 16

mb

14

400 Pa/sec

12 Below

Transducer) Test Cycle Pass Pressure, 300 10 Level

Pressure,

Test Cycle Fail 8 dP Pass

200 (Secondary dP Fail Vacuum 6 Atmospheric Differential 4 100 2

0 0 012345678910 Test Cycle ASTM F2338‐09 Vacuum Decay for Flexible Packaging

TStroke 1.50 TEST PARAMETERS TEqual 20.00 Vac. 700.2 TTest 5.00 Vacuum, mb dP/dt, Pa/s TFill, s

600 20 Ref 450.2 35.2 15.00

mb 500 Pa/sec 15

Test # Vacuum, mbBelow 400dP/dt, Pa/s Pass/Fail Comments Test Cycle Pass Pressure, Transducer)

1 644.8 300 27.3 P Good Product10 Level

2 639.3 27.3 P Good ProductPressure, Test Cycle Fail 200 3 635.7 26.7 P Good Product5 dP Pass

Vacuum 100 4 638.0 25.7 P Good Product (Secondary dP Fail Atmospheric 5 633.7 0 26.7 P Good Product0 Differential 012345678910 6 586.6 95.4 F 25 micron Test Cycle 7 576.8 90.5 F 25 micron 8 638.0 56.6 F 15 micron 9 634.7 52.4 F 15 micron 10 636.0 40.4 F 10 micron 11 641.6 39.4 F 10 micron Vacuum Decay Applications

• Hermetically Sealed Packaging (Flexible, Rigid, Semi‐Rigid)

• ® Lidded Trays • Components & Fixtures 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 Vacuum • Repeatable Decay •Non‐Subjective •Zero Waste Airborne Ultrasound Through Transmission Ultrasonic Signal

Propagate through single or multiple layers of well bonded materials.

Reflection/absorption of sound waves by multiple layers. Seal‐Scan® Online Pouch Seal Inspection Optimizing the Sealing Process

100.0

80.0

60.0

40.0

20.0

Max 0.0 Min 100 110 120 130 140 150 160 170 180 190 Signal Value -20.0

-40.0 As the the at which the seal is created increases, the maximum signal values are not affected. However, the -60.0 minimum values experienced increase with higher , producing optimum seals at 160 and 180. -80.0

-100.0 Temperature at Which Pouch is Sealed Mass Pressure Analysis (g/cm2)

50.00

40.00

30.00 y = ‐28.06ln(x) ‐ 117.06 20.00

10.00

Avg, % 0.00 0.0000 0.0100 0.0200 0.0300 0.0400 0.0500 0.0600 0.0700 ‐10.00

‐20.00

‐30.00

‐40.00

‐50.00 t*ru, g/cm2 Seal‐Scan® and Peel Strength Testing

10

9

8

R2 = 0.833 Avg Load Maximum Load 7 Linear (Avg Load) Linear (Maximum Load)

6 Peel Strength Average Load (N) Load Average Strength Peel

5

R2 = 0.7895 4 5 7 9 1113151719 Ultrasonic Standard Deviation 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. Ultrasound Summary

• Non‐destructive • Quantitative • Optimize Process • Characterize Materials • On‐Line Capability • Traceable Standards • Analyze, Improve, Control High Voltage Leak Detection (HVLD) HVLD Defect Detection for Pouches

• Micro leaks down to 5 microns • Pinholes • Cracks • Crystallized leaks • Channel defects HVLD Technology

• High voltage applied to • Ideally non‐conductive materials • Liquid triggers conductivity spike HVLD Online Pouch Inspection

Designated electrode design for critical ports and welds.

Size Capacity 100~1,000 ml 6,000/ bags hr. HVLD Detection HVLD Applications

• Non‐porous, Non‐conductive • Package Contents: ‐ liquid products ‐ protein based liquids ‐ suspensions or emulsions • Flexible or Rigid Barrier HVLD Summary

• High Speed 100% On‐line • Liquid Fill Packaging • Targeted Inspection • Quantitative • Detects Critical to Quality Defects Two Main Goals:

Eliminate Waste Improve Quality

Non‐Destructive Testing Two birds with one stone. The Ideal Test Method

Informative Accurate Simple Cost Effective Reduces Waste Increases Productivity Six Sigma Framework

Define Measure Analyze Improve Control Thank You! Oliver Stauffer [email protected] 914.337.2005 www.ptiusa.com