Porous Packaging Inspection Solutions Non-Destructive Package Testing

Transcription

1 Porous Packaging Inspection Solutions Non-Destructive Package Testing

2 Package Integrity Syringes Blister Packs Transfer of environmental contaminants. Synergistic effects of contaminants (O 2, H 2 O, Bacteria). Maximum Allowable Leakage Limit (MALL) Vials / Ampoules Transdermal Patches Auto Injector

3 Three Applications Porous Header Bag Porous Lidded Tray Hermetically Sealed Pouch/Tray

4 The Challenge Kirsch, et al, PDA J Pharm Sci & Technol 51, 5, 1997 p. 200

5 100% inspection using definitive measurable methods provides much needed answers. Supplier Process Pinholes Seals Cracks Delaminations Design Personnel Pinholes Seals Cracks Tears/Abrasions Configuration Other Pinholes Seals Tears/Abrasions Other 100% Seals

6 Manual Visual Inspection Channel leaks down to 75 μm [0.003 in.] with a % probability 1. 80% 80% 80% 80% Assumptions 1,000 Packs/Day 1% Defect Rate 10 Defects/Day ~2,500 Defects Per Year 100% Inspection = 500 Defects/Year 400% Inspection = 4 Defects/Year Probability of Detection Time on Task, min Drury & Watson, 2002 Visual Physical 1

7 Speed-Capability Detection Capability Speed Measurement access and detail Reliability of measure Non-subjective, manageable and traceable

8 DMAIC 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.

9 Deterministic Methods Non-Destructive vs. Destructive Quantitative vs. Attribute Non-Subjective vs. Operator Dependent Calibration Capability Validation Effectiveness Simple Methodology (no sample prep) DETERMINISTIC vs. PROBABILISTIC Without a reliable test method you have no test method.

10 ASTM F Vacuum Decay Medical Device

11 P, mbar dp, Pa ASTM F Vacuum Decay Time, sec 0

12 dp, Pa Vacuum Decay for Non-Porous Packaging ASTM F cc/min 0.85cc/min 0.50cc/min Simulated Leak Rate

13 ASTM F for Tyvek Package Leak Testing

14 Tyvek Tray Test Results Vacuum Level, mb 127 cc/min cc/min 49 cc/min 22 cc/min (1.5)* 100 Micron Wire 75 Micron Wire Good (3.3)* (3.8)* Differential Pressure, mb 127 cc/min cc/min cc/min 22 cc/min (1.0)* 100 Micron Wire 75 Micron Wire Good 7.1 (2.2)* 25.2 (1.8)* * 3 x Standard Deviation (99% Confidence Range)

15 Differential Pressure, Pa Pinhole vs. Channel Defect µ Pinhole ~44 sccm µ 20mm Channel ~6.4 sccm micron 100 micron Expon. (75 micron) Expon. (100 micron) 75µ 40mm Channel ~3.2 sccm Capillary Length, mm

16 Micro Capillary

17 Large Format Tyvek Applications 80cm x 20cm

18 Large Tray Sensitivity Vacuum, mbar Good Bad Sample ID round1 round2 round3 1~30 - Normal good um wire um wire um wire 34 - channel 35 - seal open on the corner

19 Differential Pressure, mb Pressure, mb Distinct Process Characterization Absolute Vacuum Sample Set Groups Differential Pressure Sample Set Groups Round 1 Round 2 Round 1 Round 2 Incomplete seals Dot pattern Seal Inclusions Channel leaks Wrinkles Pinholes/Cracks in Tray

20 Porous Header Bag

21 Airborne Ultrasound Through Transmission ASTM F

22 Seal-Scan Technology

23 Airborne Ultrasound Seal Analysis Offline Seal Imaging Online Seal Inspection

24 C-Scan C-Scan Seal width profile Seal width profile L-Scan L-Scan Avg Min Max StD Avg Min Max StD

25 Optimizing the Sealing Process Maximum and Minimum Signal Values at Different Temperature Signal Value Max Min 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 Temperature at Which Pouch is Sealed

26 Typical Seal Defects Good Seal Incomplete Seal Critical Incomplete Seal Critical Wrinkle/Inclusion Major Inclusion Minor

27 Sealer Integration

28 Positive Controls

29 Positive Controls

30 Positive Controls

31 Positive Controls

32 Airborne Ultrasound Non-Destructive Seal Inspection Quantitative Materials Analysis Flexible and Semi-Rigid Packaging Seal Process Optimization On-line Defect Detection

33 5 Technologies VACUUM DECAY AIRBORNE ULTRASOUND DETERMINISTIC QUALITY FORCE DECAY HIGH VOLTAGE VOLUMETRIC IMAGING

34 Deterministic Methods Non-Destructive vs. Destructive Quantitative vs. Attribute Non-Subjective vs. Operator Dependent Calibration Capability Validation Effectiveness Simple Methodology (no sample prep) DETERMINISTIC vs. PROBABILISTIC Without a reliable test method you have no test method.

35 Global Quality Solutions Thank You!