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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
Company profile
Founded Annual turnover Employees, total Total staff vision system development, integration, installation : Products 1895 20 mio 150 52 Inspection machines Vision systems Vial and ampule washers Tablet sorting and inspection Markt Schwaben/Munich SVResearch,Harrisburg, PA Seidenader Equipment, Florham Park, NJ Agents and tech. support partners 49 worldwide
Locations
Seidenader
New Building for future Growth for Seidenader Maschinenbau and SVResearch, Germany
MUC Airport
Seidenader
Office space: 2,100 sqm Factory space: 2,100 sqm 130 employees
Seidenader
Total sales / Automatic inspection machines
100 %
1996
1997
1998
1999
2000
2001e
Seidenader
Accumulated Inspection Experience
Total Semiautomatic inspection machines ca. 650 Last 3 yrs ca. 120
79 1500
45 350
Seidenader
Semiautomatic inspection machines
- For ampules, cartridges, vials and bottles - Particles and cosmetic defects - Freeze dried products - Prefilled syringes
Seidenader
Automatic inspection machines
- For ampules, cartridges, vials and bottles - Particles and cosmetic defects - Freeze dried products - Prefilled syringes
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Prefilled syringe processing Industry trends Heparin manufacturers are increasing syringe manufacturing capacity
Manufacturers in Japan,Europe and USA start to build up filling capacity for prefilled plastic syringes
- Greater variety of syringe types - Greater demand for automation of the inspection process
Seidenader
What makes syringe inspection different? Material handling challenges
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
Machine overview
Seidenader
Material handling challenges
Avoid timing screws and guide rails - they potentially scratch the syringe or the print - they tend to wear quickly by broken syringes
Seidenader
Material handling challenges
Needle up particle inspection for syringes > 10mmdiameter - provided liquid moves freely - product does not tend to foam or bubble
Seidenader
Material handling challenges
Needle down particle inspection for syringes < 10mm diameter - liquid cannot move freely due to siliconisation,surface tension or viscosity of the product
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Controls architecture of vision systems
Seidenader
Seidenader
SVIM-Processor
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
What to look for in a syringe ? Inspection areas
Finger flange Plunger Fill level Liquid/ particles
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
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Seidenader
How to look for defects ? Particles
Good
Seidenader
Particle inspection
Seidenader
Particle inspection
Seidenader
Detection performance Particle inspection
120% 100% 80% 60% 40% 20% 0% 30 Automatic inspection Manual inspection
50
75
100
200
300
Source : Abbreviated version of data published by Dr. John Shabushnig, Pharmacia Corporation, USA Seidenader tests on Pi 30 machines with calibrated glass particles
Seidenader
Particle detection performance comparison Machine vs machine Product 1 Line Sensor Polymers< 100y Glass fragments 100-200y Glass fragments 500y Glass fragments >1,0mm Fibers 500y - 1,0mm Floaters 75,9 57,8 85,2 93,3 75,1 60,0 Seidenader 99,4 68,9 84,7 99,3 93,5 100
Seidenader
Particle detection performance comparison Double blind study Product 2 Line Sensor Seidenader Human
Glass fragments 100y-1,0mm 55,6 Fibers Empty Underfill 5% Underfill 10% Overfill 10% 60 100 80,0 100 93,3
Seidenader
Detection performance comparison Knapp samples AventisPasteur, France
AventisPasteur collected Knapp set to evaluate performance of new Seidenader SI machine, built for AvP, Swiftwater, PA. A set of 215 syringes (148 good, 67 particle defects) was put together and run on the machine 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 at AvP, Val de Reuil, F. The product was influenza vaccine, a light suspension, based on aluminium hydroxide
Seidenader
Detection performance comparison Knapp samples AventisPasteur, France Defect Glass, large (>5mm) Glass,mid size (1-5mm) Glass, small (100-1000u) Plastic White fiber White particles Colored particles/fibers Overall False rejects Manual 100 99 62 71 45 45 60 79 1,50 Existing 100 100 71 65 52 39 61 79,1 2,20 Seidenader SI 30 100 100 77 91 99 100 62 89 1,20
Seidenader
Detection performance comparison Knapp samples AventisPasteur, France Biggest Challenges White particles/fibers in suspension Seidenader have developed special vision tools and light technique to enhance the contrast of these defects. A combination of light absorption and light scattering methods are used in conjunction with double polarisation Large, non moving particles / Chips A special inspection window is used to detect light absorbing or reflecting edges/lines in the bottom part of the syringe Airbubbles in the liquid A contour tool was used in conjunction with the standard blob analyzer, to allow separation of small glass and plastic particles and airbubbles by their profile. This allowed to inspect at a higher sensitivity without increasing the false reject rate for these defects.
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
How to look for defects ? Flange defects
Seidenader
How to look for defects ? Flange defects
Seidenader
How to look for defects ? Sidewall defects
Pic 1
Pc 2
Pic 3
Good
Cracks
Fill level
Defects Particles sticking to sidewall Fill level Cracks above / below the plunger Presence of print
Seidenader
How to look for defects ? Sidewall defects
Pic 1
Pc 2
Pic 3
Seidenader
How to look for defects ? Plunger defects
Good
Damaged plunger
Seidenader
How to look for defects ? Plunger defects
Seidenader
How to look for defects ? Needle shield / Tip cap defects
Good
Wrong position
Defects
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Validation support Team of 4 dedicated specialists in Seidenader No external consultants or third party Experience of over 50 IQ/OQs on Seidenader machines in US and Europe Kick off meeting/ Audit / Validation matrix Protocol design and review Execution of protocols w/ Seidenader specialists support on site Standard protocols or completely customized and execution by Seidenader available as option
Seidenader
Validation approach 1 OQ Focus on samples PQ
B >/ = A
2. PQ Batch
Seidenader
Validation approach 2 Focus on Production
FAT/SAT
IQ/ OQ
Sample set
Define capabilities
compare Data
Overall machine must outperform manual method Inspect production manually Reinspect Good and Bad on machine
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Different levels of Training
Operator & Maintenance Training To understand how to operate and maintain m/c, cleaning, status messages, documentation, simulations Training on machine at customer 3-4 days after installation
To understand principles of vision processor, light, inspection tools, filters, etc Training courses regularly in MUC and HBG 3-4 days before FAT
Seidenader
Agenda
Intro Seidenader Maschinenbau Syringe inspection Material handling Vision system Particle inspection Cosmetic inspection Validation approaches Training requirements References
Seidenader
Experience w/ automatic inspection of syringes
SI 20/30/40 Syringes up to 400/min Leo Pharma, Vernoillet, F Aventis Pharma, Maison Alfort,F Aventis Pharma, Le Trait, F Rovi, E Federa, B Solvay, NL Aviron, USA Schering Plough, USA Becton Dickinson, USA 2x 3x 2x