Knaap Test

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Taip ei, 14 th May 2012Sem inar on leak test and part icles insp ection

UTEK INTERNATIONA L COMPA NY 1


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SUMMARY

SUMMARY

Part 1Leak detection

Particles inspection

Part 2Presentation of Convel

Products overviewTS Leak detection machine

C2/C2D Automatic particles inspection machine

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LEAK DETECTION

LEAK DETECTION

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METHODS FOR LEA K TEST

LEAK DETECTION

Method Description Advantages Drawbacks

Methylene bluebath

Samples of containers areput in a bath of dye and

pressure is applied .Colour enters insideleaking containers

changing the colour ofliquid.

Containers are thenrechecked to recognizeand reject the coloured

ones

Easy to be performedwithout skilled people

Possibility to send out aleaking container due to wrongvisual recheck

Difficulty to be applied tocoloured products

Difficulty to be applied tovials

Slow Problem of cleaning the

container of the bath and towaste the dye

Low sensitivity Suitable only to test samples

and not 100% of production

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LEAK DETECTION


Vacuum/Pressurecycle in autoclave

Standingampoules

A cycle of high pressure isperformed inside the autoclave.Due to the difference of pressure,the tips of leaking containersexplode.The ampoules are thenrechecked for missing or brokentips.

Ampoules withbroken tips are easy tobe recognized

All containers must berechecked

The method can detect onlybig cracks present only in thetips, bottom part is excluded

Sensitivity is very low

Vacuum/Pressurecycle in autoclave

Upside downampoules

Ampoules are put upside downinside the autoclave A cycle ofhigh pressure is performedinside the autoclave.

Due to the difference of pressure,the liquid goes out from theleaking tip .The ampoules are thenrechecked by automaticinspection machines for fillinglevel

Easy Higher sensitivity for

the detection of thecracks in the tip with

respect to standingampoules method

The method can detect crackspresent only in the tips, bottompart is excluded

Sensitivity is low

Very slow and tedious due tothe need to reverse theampoules

Inspection machines areusually not setup to detect thedifference in filling level due toleaks of just some drops

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LEAK DETECTION

Name Description Advantages Drawbacks

High Voltage An high voltage (up to 35KV) is applied to the

container and the currentpassing through it ismeasured.In case of presence ofmicrocracks, the liquidinside the ampoulebecomes conductive.

Fast automatic test on100% of production

High sensitivity (cracksin the range of micron)

100% of containersurface can be tested

Easy to be applied toall types of containers,vials with metallic alucapsealing too

Applicable only to liquidproducts

Depending on conductivity ofthe product (distilled water oroily products are difficult to betested)

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PRINCIPLES OF HIGH VOLTAG E METHOD

LEAK DETECTION

High voltage sparks are generated between thetip and the bottom of the container.

Glass is a perfect isolating material: onlyminimal current passes through a perfectlysealed container.

In case of microholes, the liquid inside makes akind of short -circuit; so a high current passes

through it

Necessary condition is that liquid wets all the

internal sideglass of the container from thebottom up to the top. Thats why it is required

the positioning in horizontal

High voltagecontroller

HVelectrode

Test areaLV

electrode

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GENERATION OF HIGH VOLTAGE

LEAK DETECTION

The maximum voltage required for this application isin the range of 30-40 KV .

A dedicated transformer is required to generate itfrom low voltage and a resistors shunt to limit thecurrent passing through the container.

Convel electronic generates trains of pulses of sparksup to 40 kV at about 800 Hz; with respect to methodsbased on DC current, it has the important advantage

to reduce the overheating of transformer and ofcircuitry and to control the average energy

transferred to the container.

These pulses are generated by a compact and ruggedelectronic device all included in a metallic box.

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MEASUREMENTS

LEAK DETECTION

The signal coming from the system electrodes +ampoule must then be analyzed.

Two values are used to analyze the signals:

Peak value: proportional to the maximum current

Average value: Convel has patent pending a specialalgorythm to calculate a kind of average signal in case

of pulsed sparks

Note: the measurements give information about thepresence of the crack and not about its dimension

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LEAK DETECTION

Production of high voltage sparks doesntdamage the normal product.

Very few energy, even less than 0,8 J in case ofConvel technology, is transferred to the

container.

Inactive vaccines can be tested too.

The stability test, performed before and afterinspection, is used to verify it.

Test isnt dangerous for the operator: onlyminimal current passes through the electrodes.

However, for full safety, the spark isnt emittedwhen covers are open

The high voltage has the natural effect to produceozone (O 3) that must be evacuated by the working

area

OPERATORS SAFETY A ND PRODUCT DEGRA DATION

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VALIDATION OF HIGH VOLTAGE METHOD

LEAK DETECTION

Highest sensibi l i ty method: microcracks in the range of 1-10 micron,compatible with microorganism dimension, can be detected

Validation is performed testing containers with calibrated holes

A laser is used to create holes of various calibrated diameters covering therange of 10 100 micron for validation test

Several systems homemade to create holes can be easily performed toprepare batches with holes, not calibrated, in the range 70 - 100 micron for

periodical check

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PARTICLES INSPECTION


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METHODS FOR PARTICLES INSPECTION



Manual inspection The operators checkvisually the presence ofparticles. They take by

hand some containers andshake them in front of a

double background (blackand white)

Operator is capable todistinguish easily particlesfrom glass defects orprinting

Not repetitive inspection highlydepending on operator attention

Slow, tedious and tiring job. Many operators are required

for inspection of high volumesand they must be regularlyreplaced

Semiautomaticinspection

A machine transports thecontainers in front ofoperator ad providesshaking, rotation and

illumination.

The operator checks thecontainers through a lens

The operator doesntneed to handle thecontainers

The containers arepositioned, rotated and

lighted always in the samerepetitive condition Suitable to mid volumes

production: one machinereplaces 4-6 operators

Simple and easymaintenance

More repetitive inspection butstill depending on operatorattention

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METHODS FOR PARTICLES INSPECTION



Automaticinspection

A machine spins thecontainers and a camera

controls the presence ofparticles. Inspection isrepeated twice for more

safety.Filling level is checked too

as standard.

Very fast: there aremachines for 150-200-

300-400 pcs/hr Repetitive Easy to be validated by

means of Knapp test

Some false rejects can becaused by presence of

imperfections or large printingson glass sidewalls, Some difficulties to inspect

coloured or foaming products Skilled operators required for

maintenance and new productssetup

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PRINCIPLES OF PARTICLES AUTOMATIC INSPECTION


The PC acquires a sequence ofimages of the same container that

are compared each to the otherusing the algorithm called Image

subtraction.

This method al lows to dist inguishthe f ixed objects l ike print ings or

dust from m oving objects l ikeparticles.

Fixed objects (green circ le) arepresent always in the same pixelsin al l the images; instead, mov ingparticles (red cir cle) are detected

in different parts o f con tainer.

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ILLU MINATION SYSTEMS



Bottom light (Tyndalleffect)

A high power LEDilluminates the container

from the bottom.

Glass particles reflects thelight towards the camera

becoming very bright andwell visible

Even very small glassparticles becomes visible(below 40 micron)

Some false rejects can becaused due to the collateraleffect of undesirable reflections

caused by imperfections orlarge printings on glasssidewalls,

The meniscus must becovered and cannot beinspected

Dark particles or low reflectingas fibers) are difficult to bedetected

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Diffused backlight A matrix of LEDilluminates the containerfrom the back with a

diffused uniform light.

Dark particles produce ashadow blocking thepassage of light

Not reflecting darkparticles become visible

Meniscous area can beinspected too

Only very dark and bigparticles are visible; reflectinglight particles are not detectable.

Only in double polarizedversion it is possible to detectfibers

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Collimated backlight A structured linear lightwith parallel beamsilluminates thecontainer from the back

Particles produce ashadow blocking thepassage of light

A linear camera detects

the presence of particles

All kinds of particles(reflecting and notreflecting) are visible

Meniscus area can beinspected too

Repetitive inspection

Sensitivity is lower than withTyndall effect. Only particlesover 50 micron can be detected.

Only the central part of thecontainer is inspected

Use of linear camera doesntallow to see the acquiredimages; its difficult for theoperator to understand thecorrect working of the machine

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KNAPP TEST


Knapp test is a statistical approach to the problem mediating the needs of the productionwith the needs of quality.

The manufacturer must prepare a batch with 250 containers. 80 containers must be rejectswith different types of defects (fibers, small glasses, heavy glasses, ) and the remaining170 must be taken randomly from the real production.

Each container will be identified univocally by a label with a number.

This batch must be checked visually 10 times by 5 different operators for a total of 50inspection for each container. Its important to check the containers reproducing theconditions of standard production (speed, illuminations, etc )

Now, the same batch must be tested 10 times by the automatic machine.

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KNAPP TEST


Each container will have a Quality Factor, that is the number of times it was rejected (normalizedto 10). For example, the container number xyz could be rejected 8 times on 10 inspection byautomatic machine (QF=8) and 35 times on 50 inspection by the 5 operators (QF= 7).I consider now only the containers with QF>=7 and I sum all the number of times they have beenrejected. The result is the QF total.

A graphic, like the one in following page, must be prepared and the crossed quality factor mustbe calculated.The evaluation of the results is based on two concepts:

1)QF Automatic >= QF manual

2)The splitting between surely good (0 rejects on 10 inspection) and the surely bad (10 rejects on10 inspection) must be as much clear as possible with a grey zone (the containers rejected 4-5-6times) as small as possible.

NOTE: Convel machines have software application for Knapp test automatic execution, calculationof QF factors and printing of graphic chart.

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CONVEL

PRESENTATION OF CONVEL

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CONVEL

Convel was founded in 1994 in Vicenza, in North East of Italy.

Aim of this company was the design and manufacturingof electronics equipment.

Since the beginning Convel proposed itself as a R&Doutsource group for development of fully new projects: from idea to final product.

In 1998 there was the first contact with pharmaceutical world through somecompanies located near Vicenza.

By means of know-how coming from the most wide sectors, Convel was capableto supply solutions highly innovative. Actually, Convel has three patents forapplications in pharmaceutical inspection.

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CONVEL

Convel became soon the supplier of core technology (leak test modules, visionsystems, interface software) to well known manufacturers in pharmaceuticalworld.

Starting from 2009, Convel decided to become itself manufacturer of machineswith its own brand and not only supplier of technology.

In only a couple of years a full range of inspection machines was developed.(automatic, semiautomatic, leak test, comby machines, test bench ).

Vertex of the fast growing up and demonstration of quality of its production werethe recent sales of the model TS for leak test to the multinational Sano fi Aventisin Italy and of the bench EasyTS to the Laboratory of research for aseptic fillingof Nestl Waters in Marysville, Ohio, USA.

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PRODUCTS OVERVIEW

PRODUCTS OVERVIEW

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C2: up to 12000 pcs/hr

C2D: up to 24000 pcs/hr

Ampoules up to 22.5 diam.Vials up to 39 mm diam.

Standard: particlesinspection and filling level

Option: ampoules tip, vialsalu-cap inspection

Various lighting system(backlight or bottom light)

with long life LED

Intermittent motion

PRODUCTS OVERVIEW

C2 /C2D - Au tom atic insp ection mach ine

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PRODUCTS OVERVIEW

For liquid products

Ampoules and vials up to 32 mm diam.Up to 24000 pcs/hr

High voltage method

Minimum conductivity of product2-5 microSiemens/cm

Continuous motion

TS - Leak test m achin e

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PRODUCTS OVERVIEW

Ampoules and vials up to 32 mm. diam.

Standard: particles inspection, filling leveland leak test (all in one)

Option: ampoules tip and vials alu-capinspection

Up to 12.000 pcs/hr

Various lighting system (backlight or bottomlight) with long life LED

Intermittent motion

3700 x 1350 x 1900 mm

C2 + TS - Particles + leak test mach ine

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EASY TS Bench for off l ine leak test

PRODUCTS OVERVIEW

Material Glass - PET HDPE - PE

Container Bottles, ampoules, vials,plastic bags, all kinds of BFS

Product Liquids, distilled water, drinksProductconductivity

Over 5 - 10 microSiemens/cm

Sensibility detection threshold compatiblewith microorganismdimensions

Method of test non destructive control usinghigh voltage method test

Dimension 400x360x570mm

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PRODUCTS OVERVIEW

RC Semi Autom atic Inspect ion Machine

Inspection of foreign matters in

liquid, freeze dried, powder.


High magnfication lens

Up to 6000 pcs/hr(recommended 2000 4000 pcs/hr)

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VI-L: inspection of foreign matters in liquidVI-F: inspection of freeze dried and alu-cap

of vials


High resolution LCD monitor to visualizedefects

Up to 6000 pcs/hr(recommended 1000 3000 pcs/hr)

PRODUCTS OVERVIEW

VI Semi Autom atic inspect ion Machine

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TWIN SPARK

TWIN SPA RK - TSLEAK DETECTION MA CHINE

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TWIN SPARK

CONTAINERSAmpoules up to 22.5 diam.

Vials up to 32 mm diam

SPEEDUp to 18.000 pcs/hr in standard versionUp to 24.000 pcs/hr in special version

Infeed belt

Rejected tray

Good tray

Operator panel

Test stations (2 or 4)

Infeed starwheel

Outfeed starwheels withgood - bad selection

Coonection for ozoneexhausting

GENERICS

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TWIN SPARK

SPEED: up to 24.000 pcs/hr (small sizes)

DIMENSIONS: 2975x1500x1300

WEIGTH: 400 kg.

POWER SUPPLY: 230V 50/60 Hz. 1 Ph.

POWER CONSUMPTION: 1,5 KW

UTILITIES:

Ozone exhausting connectionCompressed air

NOISE: 75 dB

TECHNICA L SPECIFICATIONS

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TWIN SPARK

To perform the test it is necessary to put theampoules in horizontal position.Convel patented a mechanical system to get itusing a starwheel and an external cam.

Advantages: The machine is very compact and simple No need of heavy big parts Incredible easyness of size change Incredible easyness of cleaning Movement of ampoules is very smooth andtheir position close to the electrodes is veryprecise and repetitive

CONVEL PATENT

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TWIN SPARK

The patented system for transportation

allows an unique semplification of themechanics and consequently of

maintenance.

Only one motor with one power beltmoves the whole machine

MECHANICS

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TWIN SPARK

Minimum detectable hole: 1 - 10 micron (tested withcalibrated samples made by laser)

Minimum conductivity of liquid required: 2 - 5microSiemens/cm

(under certain conditions even distilled water or oilyproducts can be checked)

Inspection area of ampoules (with four electrodes): tip,neck, body and bottom.

No electromagnetic noise nor interference due topresence of high voltage

PERFORMANCE

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TWIN SPARK

Machine is equipped with clutches,connected to a sensor, at infeed atoutfeed to prevent mechanical jam.

Machine is equipped with ozone (O3)

exhausting fan to evacuate it from themachine.

A software program allows to empty easilythe machine at the end of batch.

A software program allows thevisualization of the correct working of all

sensors for maintenance purpose.

Special outfeed with exact counting indouble tray for higher speed

FEATURES

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TWIN SPARK

The size change is easily performed replacing thestarwheels and selecting the recipes. All parametersare memorized in the PC.

No tools required nor skilled personnel.

15 minutes maximum time.

NO ADJUSTMENT REQUIRED FOR ELECTRODES!The electrodes are included in the size change its notrequired to adjust their position! Every time the sizehas been changed, new electrodes are in use.

Position of electrodes is fundamental to avoid falseresults. No possibility of mistakes and higher life ofelectrodes is guaranteed.

SIZE CHA NGE

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TWIN SPARK

The steel plane allows a full, easy and fast access to all parts when size parts are removed.

Liquid doesnt remain in plastic parts like wormscrew, as in competitor machine, but falls down over thesteel plane through the big holes of the central starwheel.

CLEANING

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TWIN SPARK

Electric components are selected among the most known worldwide distributed brands: Siemens PLC S7-200, Siemens inverter, ABB motors, Mitsubishi or Allen Bradley components.

ELECTRIC CABINET

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TWIN SPARK

Great effort to reduce the number ofparameters for easy and fast setup ofnew products .

Only power emitted and sensi t ivi tythresho ld for average and peak valuesare the parameters required for leak test!

HMI - Param eters

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TWIN SPARK

Visualization in real time of the last 100 results of inspection for each electrode

HMI Historical report

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C2 /C2D AUTOMATIC INSPECTION MACHINE

C2 / C2DA UTOMATIC INSPECTION MACHINE

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VISION SYSTEM

C2/C2D AUTOMATIC INSPECTION MACHINE

HW adaptable to insp ection needs, using onlystandard PC and cameras.

No need of interface board: cameras arecon nected directly to PC throug h IEEE 1394port

The software of vision system (called FastVision TM ) is fu lly dev el oped by Co nvel an dwritten in Visual Basic.

A fully programmable and configurablePLATFORM running on Windows XPintegrated with vision system and PLCsoftware.

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MACHINE CONTROL SYSTEM

TECHNOLOGY

Our machine controlSOFTWARE isa pro gramm able PLATFORMfully configurable by trainedtechnicians.

Approach to machine control

Configuration Scriptcustom level personalization

Parameters

On Fieldtechnician

FINALCUSTOMER


VISION SYSTEM

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STANDARDCOMMERCIAL

CAMERAS

TECHNOLOGY

MACHINE CONTROL SYSTEMS

FASTVISION

Standard PCLeak testmodule

PLC(Siemens)

HW

HW HW HW

SW

FASTVISION

FASTVISION

HUMANINTERFACE

OP

AUTOMATIONSW

SCRIPT


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One tray for tip defects beforeentering in the turret (rejectionby falling in a trap)

One tray for cosmetic defects

One tray for particles defects

Tray for tiprejects

Tray forcosmetic

defects

Tray for particlesdefects

Tray foraccepted

C2/C2D AUTOMATIC INSPECTION MACHINE

LAYOUT W ITH MULTIPLE REJ ECTIONS

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C2D GENERAL LAYOUT

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C2: Up to 12000 pcs/hrC2D: Up to 24000 pcs/hr

(for 1ml ampoules)

DIMENSIONS:C2: 2835x1284x2294

C2D: 2826x2408x2294

WEIGTH:C2: 600 kg.

C2D: 1.100 kg.

POWER SUPPLY:400V 50/60 Hz. 3 Ph. +N+GND

POWER CONSUMPTION:C2: 2,5 KWC2D: 5 KW

UTILITIES:Compressed air


TECHNICAL SPECIFICATIONS

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In order to allow the customer tosetup easily the machine, Convelput a great effort to reduce thenumber of sensible parameters forthe particles detection .

The effect of parametersmodification is visualized in realtime on acquired binarized images .

INSPECTION PA RAM ETERS

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A diffused light illuminates the tip

from the back.

The ampoule is framed by onecamera taking a double image at

90

through a prism.

The container doesnt need to berotated (static inspection).

Tip is inspected for height, shape,presence of code rings.


TIP INSPECTION

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A diffused light illuminates the

sealing from the back.

The vial is rotated slowly in frontof camera (dynamic inspection).

The camera takes a fast sequenceof images of the profile of the

sealing.

All 360

of the circumference isinspected.


AL U-CAP SEALING INSPECTION

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The size change is easily performedreplacing the starwheels and selecting therecipes.All parameters are memorized in the PC.

No tools required nor skilled personnel.

20 minutes maximum time.

SIZE CHAN GE

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MATERIALS:

All frame is in SS AISI 304

Parts in contact with

containers are in SS AISI 316L

Starwheels are in low frictionautolubricant plastic (PE or

POM C)

All alluminum parts areanodized

Infeed belt is in sylicon withlow friction coefficient

All mechanical parts are longlasting and maintenance free

STANDARD FEATURES

COMPONENTS:

MAIN COMPONENTS AREFROM WORLDWIDE

DISTRIBUTED BRANDS:

PLC Siemens S7-200PC Proface touchscreen

Cameras Baumer, Allied, Asynchronous motors ABB

Servomotors MitsubishiInverter Siemens

Electromechanic Siemens

Ball bearings SKFLaser printer Hewlett Packard

Sensors Yamatake, Balluff, IFMSafety switch Allen Bradley

SENSORS:

Inductive sensors for clutchesinsertion

Ultrasonic sensors forcontainers counting

Ultrasonic sensors forrejection verification

Air pressure presence sensor

Sensors for trays presence

Sensor for minimum load

Sensor for spinningverification (C2/C2D)

FEATURES COMMON TO AL L CONVEL M ACHINES

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Visualization in r eal time of all coun ters

Visualization of alarms with link to us ermanual on l ine

Possibi l i ty to print , save and export aspdf f i le on USB key; connection toethernet line and SCADA system s.

Cameras and high voltage parametersare automatical ly setup throug h pr oduct

selection.

Unlimited number of recipes ismemor izable on PC hard disk and they

remain in mem ory for years.

STANDARD FEATURES

HMI - Cou nters

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For maintenance and servicepurpose, the functioning of allsensors appear in a dedicated

screen.

All devices are activableindividually by means of a jog

pushbutton.

STANDARD FEATURES

HMI - Maintenan ce pag e

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Different alphanum eric passwordlevels (admin istrator, superviso r,

operator, maintenanc e) w ithautomatic logoff and expiring t im e.

Unlimited number of users

STANDARD FEATURES

HMI - Passwords levels

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Function Audit trail to trace the

history o f al l events memorized inthe hard dis k of PC (all alarm s,login, logout, modificat ion ofparameters, batch histo ry, . ..)

Possibi l i ty of connection to localnetwork for data backup and

restore

STANDARD FEATURES

HMI - Au di t trail & CFR21/PART11

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