HARLEQUINBLISTER AND PHARMACEUTICAL KIT INSPECTION

HARLEQUIN EVOLUTION | LITE

Harlequin is the vision system dedicated to blister and thermoforming machines for the in-spection of oral solids and pharmaceutical com-ponents.

The Software works under Windows 7 (64 bit) and uses cutting-edge hardware devices PC-Based Quad & Octa core CPU’s, very high res-olution cameras and LED light units with cus-tom-design.

In order to simplify the system self-program--

ard Tool that allows the operator to regulate both working formats and article parameters for products packaged in plastic material (white PVC, transparent, coloured) and on aluminium (ALU-ALU)

and scalability.

Harlequin Lite is the system Entry Level ver---

Harlequin Evolution is a complete vision inspec-tion system, able to manage at the same time more packaging machines, and to grant many additional checks (thanks to multifunction cam-eras) such as: barcode and 2D codes reading on cartoners, on line printed variable data with integrated printer management, printing art-works checks (PQV) from digital/flexographic printers.

TECHNICAL INFORMATION:Unlocked HMI panel during automatic workImage reconstruction for a complete object viewGraphical Oscilloscope for signal error debuggingSVM (SEA Vision Machine): integrated virtual PLC for machines rejection management Compliant to FDA 21 Cfr Part 11

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Max cameras per Harlequin: 4Tv Alucode with special Dome light for barcode or 2D check on aluminium foil: max 14 cameras, possibility to install them on separate mechine also for Pqv and other checks Image resolution and depth: high 1376 x 1032, RGB 24 bit

Max cameras per Harlequin: 2Tv Alucode with special Dome light for barcode or 2D check on aluminium foil: 1 only AlucodeImage resolution and depth: standard 768 x 576, RGB 24 bit

LCD TFT size: 12”Interface: Touch screen or trackballI/O BASE: 16 input + 16 output opto-coupled at 24V, watch-dog on outputsI/O OPTIONAL: 24 input + 24 outputs opto-coupled at 24V, watch-dog on outputs

LCD TFT size: 12”Interface: Touch screen or trackballI/O BASE: 16 input + 16 output opto-coupled at 24V, watch-dog on outputsI/O optional: 24 input + 24 output opto-coupled at 24V, watch-dog on outputs

HQ EVOWizard for the self programming of the single product

Wizard for the self programming of the multi-product

Cross check parameters/articles Optional (Components pack*)

HQ LITEWizard for the self programming of the single product

Wizard for the self programming of the multi-product

SPECIAL SOFTWARE FEATURES

HQ EVOIntegrated PLC function for the reject without additional devices

Real time display of the Shift Registers

Graphic oscilloscope for signal error debugging

Generic shift registers for tracking external signals

HQ LITEIntegrated PLC functions for the reject without additional devices

Real time display of the Shift Registers

Graphic oscilloscope for signal error debugging

REJECT

HQ LITE

Difference in area <8%

Difference in lenght <8%

Broken/chipped tablet <5% with Simmetry pack *

MEASUREMENT ACCURACY (GEOMETRICAL)

HQ EVO

Difference in area <4%

Difference in lenght<4%

Broken or chipped tablet<4%

CPU: Quad coreOS: Windows 7 Application: 64 bitTouch Screen Ram up to 8 GBHmi unlocked during the automatic workInterface: Ribbon Style

CPU: Dual coreOS: Windows 7Application: 64 bitTouch Screen Ram 2 GBHmi locked during the automatic workInterface: classic

Light: LEDNeon: noSupports BACKLIGHT for tray inspection: optional (COMPONENTS PACK*)

Light: NEON LED: optionalDoesn’t support BACKLIGHT for tray inspection

HQ EVO HQ LITE

HQ EVO

Difference in saturation <5%

Difference in hue <2%

Difference in value <5%

Dispersion RVB extreme

HQ LITE

Difference in saturation <10%

Difference in hue 5%

Difference in value <10%

MEASUREMENT ACCURACY (PICTORIAL)

MEASURED PARAMETERS

EXTRA CHECKS

HQ EVO

Multi-product management

Double tablet

Fragments in cavity

Product out of cavity

Foil splice (Extra-check pack *)

Dirty foil

Check of the machine step

Asynchronous shift register

Multifunction checks with additional cameras: ocv, pqv, barcode, programmable measures optional

Alucode optional

HQ EVO

Area (Number of pixel of the object)

Colour

Shape 1 and shape 2

Shape 3 and shape 4: simmetry

Black spots on the product

Presence of powder around the product

HQ LITE

Area (Number of pixel of the object)

Colours

Shape 1 and Shape 2

Shape 3 and Shape 4: simmetry (Simmetry pack*)

Black spots on the product (Extra check pack*)

Presence of powder around the product (Extra-check pack *)

User access FDA 21 CFR PART 11 compliant Alarms on signals Events logged into a fileAudit trails

Direct modem connectionInternet connection to SEA Vision server

According to GAMP4/5 rules

HQ LITE

Multi-product management (Multi-product pack*)

Double tablet optional (Extra-check pack*)

Fragments in cavity optional (Extra-check pack*)

Product out of cavity optional (Extra-check pack *)

Foil splice (Extra-check pack *)

Dirty foil optional (Extra-check pack*)

Check of the machine step optional (Extra-check pack*)

Alucode optional

WEB TYPE

HQ EVO

BLISTER (tablets, capsules, ecc...)

TRAY (vials, syringes, needles, kits, ecc...)

HQ LITE

BLISTER (tablets, capsules, etc...)

TRAY (vials, syringes, needles, kits, etc...) with limitation: No multi-product management

CHECK OF TABLETS AND CAPSULES ON ALU-ALUCheck of presence, colour, and integrity on tablets/capsules packaged on ALU-ALU material. Check of double product presence or foreign products in the same cavity.

CHECK OF TABLETS ON TRANSPARENT PVCPresence, colour and defects checks on products packaged in transparent PCV (clear or coloured).

BLU/TRANSPARENT CAPSULES IN BLISTERPresence check on blue/transparent capsules in blisters. The control also verifies the double pres-ence of products in the same cavity.

CHECK OF WHITE CAPSULES ON WHITE PVCThe software also performs a chromatic measure-ment of the object color, black spots detections on the product surface and tablet mix-up inside the same blister.

CHECK OF CAPSULES ON PVCPresence, color and integrity check of the capsule packaged in a PVC blister. The system detect half capsules, opened or excessively closed capsules.The colour accuracy is then granted by a double chromatic check, independent from the capsule position, aimed to recognize the two colours of the product.

TABLETS INTEGRITY IN THE BOTTLE LOADER.Check of falling tablets present in the bottle loader guide. The system controls both the tablets integrity and the correct filling of the bottle.

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BLISTERS AND PHARMACEUTICAL KIT INSPECTION

CHECK OF COMPONENTS IN TRAYCheck of the different components placed in the pharmaceutical tray and packaged in white or trans-parent PVC, and in cartons.

3D CHECK OF POWDER FILLING IN CAVITY This application inspects the correct blister’s cavity filling. With a 3D measurement of the powder inside the cavity.

CHECK OF CASE FORMING FOR COMPONENTS INSERTION Check of correct case forming and positioning of components

CHECK OF COLOUR RINGS ON AMPOULESCheck of presence and colour of rings on ampoules. The software allows the pixel sizes and the distance of ring

BLISTER IMPURITIES CHECK Check of impurity on blisters with the usage of back-lights placed under the blister.

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BLISTERS AND PHARMACEUTICAL KIT INSPECTION

CHECK OF THE BLISTERING MACHINE STEP The blistering machine step is checked through the measurement of the distance between a fixed point of the blistering machine web and a variable point inside the blister. This application is customizable.

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VIALS COUNTCount of vials in box (or inside cartons). The measure could be referred to a value set up at batch start.

CAVITY FORMING CHECK This application inspects the correct blister forming and filling (verification of the correct positioning of the tablet inside the cavity).

CHECK OF CASE FORMINGThis application verifies the correct case forming, and detects possible non compliant packages.

CHECK OF TRANSPARENT SYRINGE’S PLUNGER ROD PRESENCE IN CASE Presence check of the transparent syringes’ plunger rod included in the cases.

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BLISTERS AND PHARMACEUTICAL KIT INSPECTION

SEA VISION S.r.l.

Via Folla di Sopra 2127100 Pavia (PV) ItaliaTel. +39 0382 529576

www.seavision.itinfo@seavision.it