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Leak Testing and Inspection Machinery

2014 HGS Case Studies

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Extensive data about Bonfiglioli Engineering’s technology in laser HGA technology.

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Page 1: 2014 HGS Case Studies

Leak Testing and Inspection Machinery

Page 2: 2014 HGS Case Studies

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Scenario

Pharma Company Specifications

Container Vial

Size (ml) 15

Glass Type Tube

Glass Color Transparent

Diameter (mm) 21

Product Fill Empty, Lyophilized

Headspace Pressure (mbar) [3-80] mbar

Headspace Gas Air

Capacity (#/hour) > 18000

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Standard Samples Set Implementation

Equipment LF-HG:

Used to implement Standard Samples

Finished Vials with certified headspace conditions

Automatic Stoppering

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Reference Sample Set Build Up

ContainerSamples Number

ID FIllHeadspace Total

Pressure(*) [mbara]

Oxygen Partial

Pressure [mbara]

Oxygen

concentration [%]

15 ml

Ø 21 mm

Tube

Transparent

4 F1 Empty 3 0,6 0,06

1 F2 Lyo 5 1 0,10

1 F3 Empty 10 2,1 0,21

1 F4 Empty 20 4,2 0,42

1 F5 Empty 40 8,3 0,83

1 F6 Empty 80 16,6 1,66

(*) Hypothesis: air consists of 20,8 % of Oxygen

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Equipment used in the Case Studies

Mock-Up System:

Reference containers individually

numbered and loaded in the rotary star

wheel

Headspace Oxygen Analysis

Production speed varied according

inspection time

Laser Unit position adjusted for the

height of the Containers

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Performance Indicators

σ – Sigma Level

Measures the capability of the process to perform defect-free

P (%) – Probability of occurrence of False Results

False Negative

False Positive

IR (O2 Concentration) – Inspection Resolution

Measures the capability to distinguish between different headspace O2

concentrations

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σ Level and P

σ – Sigma

LevelP (%)

Defective

ppm

1 31,73 317300

2 4,55 45500

3 0,27 270

4 0,0063 63

5 0,000057 0,57

6 0,0000002 0,002-1σ-2σ-3σ-4σ-6σ -5σ 6σ5σ4σ3σ1σ 2σMean

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False Results Assessment, an example

Hp: Target O2 Concentration

0,06% - Conforming

0,82% - Defective

What is the probability of

occurrence:

1. False Negative

2. False Positive

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σ Sigma Level Calulation

Anderson-Darling Normality Test

If P-Value > 0,05 Data are normally distributed Sigma Level meaningful

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Case 1 – Method Overview

Container Data Item Description

15 ml Ø 21 mm,Tube, Transparent,[F1, F2, F3, F4, F5,

F6]

Equipment Mock-up

Motion Continuous

Inspection time5 time points: • 100ms, 200ms, 224ms, 300ms, 400ms

Number of HGA inspections per unit 100

Test period Over 1 day

N2 Purging Not required

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Case 1 – Activities

Anderson-Darling test passed

F6, F5 and F4 in turn taken as a reference

of non conforming containers

Performance Indicators calculated:

Process Sigma Level

Probability of Occurrence of False Results

Inspection Resolution

ID

Headspace

Total

Pressure(*)

[mbara]

Oxygen

concentration

[%]

F1 3 0,06

F2 5 0,10

F3 10 0,21

F4 20 0,42

F5 40 0,83

F6 80 1,66

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Case 1 – Findings (1)

Format ID ValueInspection Time

100 ms 200 ms 224 ms 300 ms 400 ms

F1Mean 51,31 50,63 50,66 50,37 50,37

StdDev 1,34 1,00 0,87 0,76 0,70

F2Mean 52,90 51,85 50,86 50,46 51,17

StdDev 1,77 1,16 1,15 1,12 1,02

F3Mean 55,27 54,37 54,19 54,17 54,34

StdDev 1,37 0,97 0,98 0,84 0,70

F4Mean 59,27 58,43 58,36 58,32 58,63

StdDev 1,40 1,11 1,04 0,83 0,78

F5Mean 69,22 68,56 68,42 68,07 67,71

StdDev 1,28 1,16 1,08 0,92 1,01

F6Mean 84,39 83,98 84,16 83,86 84,40

StdDev 1,33 1,13 0,89 0,81 0,76

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Case 1 – Findings (2)

IR (%) ReferenceInspection Time

σ –

Sigma

Level

100 ms 200 ms 224 ms 300 ms 400 ms

1,60 F1-F6 12,36 12,66 12,65 12,75 12,75

1,56 F2-F6 8,92 12,20 12,57 12,72 12,45

1,46 F3-F6 10,66 11,25 11,32 11,33 11,27

1,25 F4-F6 8,98 9,73 9,76 9,77 9,66

0,83 F5-F6 5,69 5,93 5,99 6,12 6,25

0,77 F1-F5 6,69 7,25 7,24 7,35 7,35

0,73 F2-F5 4,62 6,77 7,16 7,32 7,04

0,62 F3-F5 5,11 5,79 5,86 5,87 5,80

0,42 F4-F5 3,56 4,21 4,24 4,25 4,13

0,35 F1-F4 2,84 3,09 3,08 3,18 3,18

0,31 F2-F4 1,80 2,65 3,00 3,15 2,89

0,21 F3-F4 1,43 1,75 1,81 1,82 1,76

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Case 1 – Findings (3)

IR (%) ReferenceInspection Time

P (%)

100 ms 200 ms 224 ms 300 ms 400 ms

1,60 F1-F6 0 0 0 0 0

1,56 F2-F6 0 0 0 0 0

1,46 F3-F6 0 0 0 0 0

1,25 F4-F6 0 0 0 0 0

0,83 F5-F6 0 0 0 0 0

0,77 F1-F5 2,2*10^-11 0 0 0 0

0,73 F2-F5 4*10^-3 1,2*10^-9 8,1*10^-11 2,5*10^-11 1,9*10^-10

0,62 F3-F5 3*10^-5 6,9*10^-7 4,6*10^-7 4,3*10^-7 6,5*10^-7

0,42 F4-F5 0,04 2,5*10^-3 2,2*10^-3 2,1*10^-3 3,6*10^-3

0,35 F1-F4 0,45 0,20 0,21 0,15 0,15

0,31 F2-F4 7,14 0,81 0,27 0,17 0,38

0,21 F3-F4 15,30 8,02 6,99 6,84 7,83

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Case 1 – Findings (4)

Inspection

Time

(ms)

Equivalent (*)

Production

Speed (cpm)

100 334

200 167

224 149

300 111

400 84

(*) 1 Laser unit installed

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Case 2 – Method Overview

Container Data Item Description

15 ml Ø 21 mm,Tube, Transparent,

[F1, F1_1_L,F1_2_L, F1_3_L]

Equipment Mock-up

Motion Continuous

Inspection time5 time points: • 100ms, 200ms, 224ms, 300ms, 400ms

Number of HGA inspections per unit 100

Test period Over 1 day

N2 Purging Not required

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100 HGA inspections of 4 samples of the set F1

Found consistency between individual results

Actions:

0,215 cc of air injected into F1_1_L

0,3 cc of air injected into F1_2_L

0,4 cc of air injected into F1_3_L

After 1 minute interval F1_1_L, F1_2_L, F1_3_L inspected again 100 times

Case 2 – Activities

Format

IDValue

Inspection

Time

224 ms

F1Mean 51,33

StdDev 0,95

F1_1_LMean 51,18

StdDev 0,88

F1_2_LMean 51,94

StdDev 0,95

F1_3_L4Mean 51,26

StdDev 0,98

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Air injected in the container simulates a leakage over a time interval

Direct correlation between flow rate over time and orifice size

Hp:

Time interval T = 1 min

Pressure differential between container inside & outside ΔP 1 bar

Leakage / orifice size:

0,215 cc 5 µm

0,3 cc 5.92 µm

0,4 cc 6.85 µm

Case 2 – Flow Rate VS Hole Size

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What happens:

Pressure rise resulting from pinholes

Case 2 – Headspace Leak Rate Model

Headspace

Total

Pressure

[mbara]

Oxygen

Partial

Pressure

[mbara]

Leakage Rate (cc)

0,215 0,30 0,40

14,52 0,30% 60 43 32

20,26 0,42% 84 60 45

27,01 0,56% 112 80 60

Time (sec)

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Case 2 – Findings (1)

Air Injected (cc) Reference

Time Points

σ –

Sigma

Level

100 ms 200 ms 224 ms 300 ms 400 ms

0,215 F1-F1_1_L 4,39 4,33 4,37 4,34 4,47

0,3 F2-F1_2_L 6,36 6,27 6,17 6,18 6,29

0,4 F3-F1_3_L 7,42 7,41 7,35 7,42 7,58

Results:

A leakage of 5 µm can be detected at > 4,3 sigma level

A leakage of 6 µm can be detected at > 6,1 sigma level

A leakage of 7 µm can be detected at > 7,3 sigma level

Air Injected (cc) Reference

Inspection Time

P (%)

100 ms 200 ms 224 ms 300 ms 400 ms

0,215 F1-F1_1_L 1,1*10^-3 1,5*10^-3 1,2*10^-3 1,4*10^-3 7*10^-4

0,3 F2-F1_2_L 2*10^-8 3,6*10^-8 6,6*10^-3 6,5*10^-8 3,1*10^-8

0,4 F3-F1_3_L 0 0 0 0 0

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Case 2 – Findings (2)

Air

Injected

(cc)

Inspection TimeEquivalent Air

Flow (cc/min)

Equivalent Hole

Size (µm)100 ms 200 ms 224 ms 300 ms 400 ms

0,215 35 36 35 36 34 0,126 3,84

0,3 25 26 25 26 24 0,126 3,84

0,4 19 19 19 19 18 0,126 3,84

Split Time (sec)

Results:

A leakage of 3,9 µm can be detected at > 3 sigma level

Time needed for a 3 sigma process

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Thank you!

Questions & Comments?