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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

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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

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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