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Seidenader
A3P Congress
BiarritzFrance
October, 2001
Seidenader Maschinenbau GmbHInspektionssystemePharma
Automatic Inspection of Prefil led Syringes
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Seidenader
Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
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Company profile
Seidenader
Founded 1895
Annual turnover 20 mio
Employees, total 150Total staff vision system development,
integration, installation : 52
Products Inspection machines
Vision systemsVial and ampule washers
Tablet sorting and inspection
Locations Markt Schwaben/Munich
SVResearch,Harrisburg, PA
Seidenader Equipment,
Florham Park, NJ
Agents and tech. support partners 49 worldwide
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Seidenader
New Building for future Growth for
Seidenader Maschinenbau and SVResearch, Germany
MUC Airport
Office space: 2,100 sqm - New Vision Laboratory
Factory space: 2,100 sqm - Training facilities130 employees - New workflow philosophy
Seidenader
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Total sales / Automatic inspection machines
1996 1997 1998 1999 2000 2001e
Semiautomatic&others
Automatic m achi nes
Seidenader
100 %
Company growth driven by automatic inspection machines
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Accumulated Inspection Experience
Seidenader
Total Last 3 yrs
Semiautomatic inspection machines ca. 650 ca. 120
Automatic inspect ion machines 79 45
Vision systems/processors integrated 1500 350
Total staff vision system development, integration, installation: 52
Seidenaderis an experienced player in both worlds
S id d
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Semiautomatic inspection machines
Seidenader
- For ampules, cartr idges, vials and
bottles
- Particles and cosmetic defects
- Freeze dried products
- Prefil led syringes
S id d
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Automatic inspection
machines
Seidenader
- For ampules, cartr idges, vials and
bottles
- Particles and cosmetic defects
- Freeze dried products
- Prefil led syringes
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Seidenader
Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
S id d
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Seidenader
Prefil led syringe processing
- Greater variety of syringe types
- Greater demand for automation of the inspection process
Heparin manufacturers are increasing syringe manufacturing capacity
Growing market of vaccines in classic and needle less syringes
Manufacturers in Japan,Europe and USA start to build up f illing capacity forprefilled plastic syringes
Industry trends
Seidenader
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Material handling challenges
What makes syringe inspection different?
Seidenader
Products are delivered to the machine in hanging position
Standard methods of conveying and buffering cannot be used
Typical handling is with starwheels, vacuum star wheels, clips and grippers
Seidenader
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Machine overview
Seidenader
Seidenader
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Material handling challenges
Seidenader
Avoid timing screws and guide rails
- they potentially scratch the syringe or the print
- they tend to wear quickly by broken syringes
Seidenader
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Material handling challenges
Seidenader
Needle up particle inspection for syringes > 10mmdiameter
- provided liquid moves freely
- product does not tend to foam or bubble
Seidenader
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Material handling challenges
Seidenader
Needle down particle inspection for syringes < 10mm diameter
- liquid cannot move freely due to siliconisation,surface tension
or viscosity of the product
Seidenader
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Seidenader
Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
Seidenader
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Seidenader
Controls architecture of vision systems
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Seidenader
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SVIM-Processor
Seidenader
A complete vision engine:
- Dual Pentium I III power for easy and complex
Vision applications.
- Standard PC Interfaces for easy and standarized
communication.
- 4 asynchronous camera inputs for 4 independant
inspections.
- Windows NT - a well-known and secure operating
system.
- SVObserver
The Interface for easy configuration contains an
extended catalogue of tools, no programming is
necessary
Seidenader
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Inspection areas
What to look for in a syringe ?
Seidenader
More components than in ampules + vials
More fragile than most vials
Therefore more images have to be taken in order to perform a
thorough inspection
Finger flange Plunger Fill level Liquid/ particles
Sidewall above / below plunger
Tip cap/ needle shield position
Seidenader
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Seidenader
Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Partic le inspection
Cosmetic inspection
Validation approaches
Training requirements
References
Seidenader
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Seidenader
Particle inspection station
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Seidenader
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Partic le inspection
Seidenader
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Partic le inspection
Seidenader
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Detection performance
Partic le inspection
0%
20%
40%
60%
80%
100%
120%
30 50 75 100 200 300
Automatic inspection
Manual inspection
Source :
Abbreviated version of data published by Dr. J ohn Shabushnig, Pharmacia Corporation, USASeidenader tests on Pi 30 machines with calibrated glass particles
Seidenader
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Particle detection performance
comparison
Machine vs machineProduct 1
Source :Thesis by Dr.J Peters, Roche, Basel, Switzerland
Line Sensor Seidenader
Polymers< 100y 75,9 99,4
Glass fragments 100-200y 57,8 68,9
Glass fragments 500y 85,2 84,7
Glass fragments >1,0mm 93,3 99,3
Fibers 500y - 1,0mm 75,1 93,5
Floaters 60,0 100
Seidenader
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Particle detection performance
comparison
Double blind study Product 2
Source :Thesis by Dr.J Peters, Roche, Basel, Switzerland
Line Sensor Seidenader Human
Glass fragments 100y-1,0mm 55,6 96,6 55,1
Fibers 60 87,3 42,1
Empty 100 100 100
Underfill 5% 80,0 100 18,2
Underfill 10% 100 100 70.4
Overfill 10% 93,3 100 51,9
Seidenader
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Detection performance comparison
Knapp samples
AventisPasteur, France
Source :Test data from comparative study by SVResearch and ,AvP, F
AventisPasteur collected Knapp set to evaluate performance of new Seidenader SImachine, built for AvP, Swiftwater, PA.
A set of 215 syringes (148 good, 67 particle defects) was put together and run on themachine on May 17-19th, 2001 at SVResearch,Harrisburg. After the test runs, the data was
compared to the data from human inspection and the existing machine atAvP, Val de Reuil, F.
The product was influenza vaccine, a light suspension, based on aluminium hydroxide
Seidenader
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Detection performance comparison
Knapp samples
AventisPasteur, France
Source :Test data from comparative study by SVResearch and ,AvP, F
Defect Manual Existing Seidenader SI 30
Glass, large (>5mm) 100 100 100
Glass,mid size (1-5mm) 99 100 100
Glass, small (100-1000u) 62 71 77
Plastic 71 65 91
White fiber 45 52 99
White particles 45 39 100
Colored particles/fibers 60 61 62
Overall 79 79,1 89
False rejects 1,50 2,20 1,20
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Seidenader
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Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
Seidenader
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Flange defects
How to look for defects ?
Defects
ChipsBroken edgesConcentricity
Method
Ringlight1 image
Seidenader
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Flange defects
How to look for defects ?
Seidenader
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Sidewall defects
How to look for defects ?
Defects
Particles sticking to sidewallFill level
Cracks above / below the plungerPresence of print
Pic 1 Pc 2 Pic 3
Good Cracks Fill level
Method
Backlight6 images
Seidenader
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Sidewall defects
How to look for defects ?
Pic 1 Pc 2 Pic 3
Seidenader
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Plunger defects
How to look for defects ?
Defects
Posit ion / OrientationLiquid between the ribsRib geometry
Liquid between ribs Damaged plunger
Method
Backlight6 images
Good
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H t l k f d f t ?
Seidenader
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Needle shield / Tip cap defects
How to look for defects ?
Defects
Gap to shoulderBanana shapes
Good Wrong position Needle shield bent
Method
Backlight3 images
Seidenader
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Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
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Validation approach 1 Focus on samples
Seidenader
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pp p
OQ
Specification
sampleset
APerformanceexistinginspection
BPerformanceautomaticinspection machine
B >/ = A
PQ
1. PQ Batch
Reinspect manuallyAdjustY / N
2. PQ Batch
AQL met ?Y / N 3. PQ
Batch
AQL met ?Y / N
Validation approach 2 Focus on Production
Seidenader
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Validation approach 2 Focus on Production
Sample set
Vendor selection Specification
Definecapabilities
FAT/SAT
Samplesvs.
specification
PQ
Inspectproduction
on machine
Inspectproductionmanually
ReinspectGood and
Badmanually
ReinspectGood and Badon machine
Repeat 2 x
compare Data
Overall machinemust outperformmanual method
IQ/OQ
Seidenader
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Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
Seidenader
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Different levels of Training
Basic SVIM Training
To understand principles
ofvision processor, light,inspectiontools, filters, etc
Training courses regularlyin MUC and HBG
3-4 days
before FAT
Vision application training
To understand features used
in specific application
Training on machine atcustomer
3-4 days
after SAT
Operator &
Maintenance Training
To understand how to
operate and maintainm/c, cleaning, statusmessages,documentation,simulations
Training on machine atcustomer
3-4 days
after installation
Seidenader
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Agenda
Intro Seidenader Maschinenbau
Syringe inspection
Material handling
Vision system
Particle inspection
Cosmetic inspection
Validation approaches
Training requirements
References
Seidenader
E i / t ti i ti f i
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Experience w/ automatic inspection of syringes
SI 20/30/40
Syringes up to 400/minLeo Pharma, Vernoillet, FAventis Pharma, Maison Alfort,F 2xAventis Pharma, Le Trait, F 3xRovi, E 2x
Federa, BSolvay, NLAviron, USASchering Plough, USABecton Dickinson, USA