HARLEQUIN

BLISTER AND PHARMACEUTICAL KIT INSPECTION

Harlequin is the vision system for blistering and thermoforming machines for the inspection of oral solids and pharmaceutical kits Harlequin was created by SEA Vision in 1995 as the first colour blister vision system for the inspection of tablets, capsules, pills and powders. Thanks to 20 years of continuous improvement, the blister inspection system can be installed on thermoforming machines, too: Harlequin is able to check vials, syringes and ampoules in pharmaceutical trays. Harlequin can measure images through an accurate check of pictorial and geometrical parameters. The software works under Windows 7 (64 bit) OS. The hardware is composed by a main unit with I/O board (PCI-Express technology), HMI panel, cameras and dedicated light units. In order to simplify the system self-programming, Harlequin has a Wizard tool that allows the operator to regulate both working formats and

article parameters through an interactive procedure. Harlequin has two versions, Evolution and Lite, which are different in terms of performances. Both Harlequin Evolution and Lite are compliant to FDA 21 CFR part 11, allowing the multi-user access to the system through the management of enabled users.

HARLEQUIN EVOLUTION Harlequin Evolution is the vision system for the inspection of product presence with high performances and flexibility. It can manage multiple packaging machines at the same time, providing several additional controls without expansion limits. Thanks to multifunction cameras, Harlequin Evolution is able to read barcodes, 2D codes, on-line printed variable data and artworks on several separate packaging machines. Harlequin Evolution features are:

Touch screen interface with ribbon graphics

Customizable icons and functions of the menu

Unlocked HMI panel during automatic work (operators can use the interface while the packaging machine is running)

Image reconstruction for a complete object view

Very high resolution colour cameras and LED light units

Wizard functions allowing the format self-programming

HIGHLIGHTS

High performances and maximum flexibility. No expansion limits

Harlequin Evolution is able to manage at the same time several

packaging machines

HARLEQUIN LITE Harlequin Lite is the vision system for the inspection of product presence dedicated to blistering machines. Its features are:

Classic HMI interface

Mechanical configurations dedicated to the main packaging machines manufacturers for an easy product presence inspection

Standard resolution cameras with neon light unit with different sizes, according to the forming web and to the packaging machine

Wizard functions allowing the format self-programming of pharmaceuticals products, packaged with different materials

Optional software packs (Symmetry pack, Extra-checks pack, Multi-product pack) can be added to Harlequin Lite, in order to improve the system’s performances.

HIGHLIGHTS

Simple and robust inspection of the product presence, but with limited

functions compared to Harlequin Evolution

Scalability: system’s performances can be improved by optional software packs

CPU: Quad core CPU: Dual core OS: Windows 7 OS: Windows 7 Application: 64 bit Application: 64 bit Touch Screen Touch Screen Ram up to 8 GB Ram 2 GB HMI unlocked during the automatic work HMI locked during the automatic work Interface: Ribbon Style Interface: classic

LCD TFT size: 12” LCD TFT size: 12” Interface: Touch screen or trackball Interface: Touch screen or trackball I/O BASE: 16 inputs + 16 outputs opto-coupled at 24V,

watch-dog on outputs I/O BASE: 16 inputs + 16 outputs opto-coupled at

24V, watch-dog on outputs I/O OPTIONAL: 24 inputs+ 24 outputs opto-coupled

at 24V, watch-dog on outputs I/O optional: 24 inputs + 24 outputs opto-coupled at

24V, watch-dog on outputs

Light: LED Light: NEON Neon: no LED: optional Backlight for tray inspection: optional

(Components pack) N/A

Max cameras for Harlequin: 2 Max cameras for Harlequin: 2 Alucode camera with special dome light for code

check on aluminium foil Alucode camera with special dome light for code

check on aluminium foil Max 14 cameras can be installed also on separate

machines for PQV and other checks N/A

Image resolution and depth: high 1376 x 1032, RGB 24 bit

Image resolution and depth: standard 768 x 576, RGB 24 bit

HARLEQUIN EVOLUTION/LITE

Technical sheets

User access FDA 21 CFR Part 11

Signal alarms

Events logged into a file

Audit trails

Direct modem connection

Internet connection to SEA Vision server

Compliant to GAMP 4/5

HARLEQUIN EVOLUTION HARLEQUIN LITE

MEASUREMENT ACCURACY (GEOMETRICAL)

Difference in area <4% Difference in area <8%

Difference in length <4% Difference in length <8%

Broken or chipped tablet <4% Broken/chipped tablet <5% with Symmetry pack

MEASUREMENT ACCURACY (PICTORIAL)

Difference in saturation <5% Difference in saturation <10%

Difference in hue <2% Difference in hue 5%

Difference in value <5% Difference in value <10%

Dispersion RVB extreme

SPECIAL SOFTWARE FEATURES

Wizard for the single product self-programming Wizard for the single product self-programming

Wizard for the multi product self-programming Wizard for the multi product self-programming Cross check parameters/articles (Components pack)

REJECTION

Integrated PLC functions for the rejection without additional devices

Integrated PLC functions for the rejection without additional devices

Real time display of the shift registers Real time display of the shift registers

Graphic oscilloscope for signal error debugging Graphic oscilloscope for signal error debugging

Generic shift registers for tracking external signals

HARLEQUIN EVOLUTION HARLEQUIN LITE

WEB TYPE

BLISTER (tablets, capsules, etc…) BLISTER (tablets, capsules, etc…)

TRAY (vials, syringes, needles, kits, etc…)

MEASURED PARAMETERS

Area (number of pixels of the object) Area (number of pixels of the object)

Colours Colours

Shape 1 and shape 2 Shape 1 and shape 2

Shape 3 and shape 4: symmetry Shape 3 and shape 4: symmetry (Symmetry pack)

Black spots on the product Black spots on the product (Extra check pack)

Presence of powder around the product

Presence of powder around the product (Extra check pack)

EXTRA CHECKS

Multi-product management Multi-product management

Double tablet Double tablet (Extra check pack)

Fragments in cavity Fragments in cavity (Extra check pack)

Product out of cavity Product out of cavity (Extra check pack)

Foil splice Foil splice (Extra check pack)

Dirty foil Dirty foil (Extra check pack)

Check of the machine step Check of the machine step (Extra check pack)

Asynchronous shift register Alucode Multifunction checks with additional cameras: OCV, PQV, barcode, programmable measures

Alucode

OPTIONAL PACKS FOR HARLEQUIN EVOLUTION:

COMPONENTS PACK includes: inspection of coloured rings, check of components presence with backlight, cross-check of parameters/articles

FOR HARLEQUIN LITE:

SYMMETRY PACK includes: shapes 3 and 4 (symmetry), inspection of broken/chipped tablet with measurement accuracy <2%

EXTRA-CHECKS PACK includes: check of double tablets, fragments in cavity, products out of cavity, machine step, black spots on the product, presence of powder all around the product

MULTI-PRODUCT PACK includes: multi-product management

COMPONENTS PACK FOR HARLEQUIN EVOLUTION

Inspection of coloured rings: check of presence and colour of rings on syringes and ampoules.

Components presence: check of the different components placed in the pharmaceutical tray.

Cross-check of parameters/articles: analysis of the articles’ archive, identifying the critical similarities among the products that could lead to a dangerous mix-up.

SYMMETRY PACK FOR HARLEQUIN LITE

Shapes 3 and 4 (symmetry): detection of 1 and 2 axes’ asymmetries on the product.

Inspection of broken/chipped tablet: detection of broken or chipped tablets.

EXTRA-CHECKS PACK FOR HARLEQUIN LITE

Double tablet: possibility to check two tablets inside the same blister’s cavity.

Fragments in cavity: possibility to check the presence of tablet’s fragments inside the blister’s cavity.

Products out of cavity: possibility to detect the products’ presence out of the cavity.

Machine step: when blisters reach the welding station, cavities must fit welding borders. If the blistering machine has not an integrated detector, Harlequin can provide this function.

Black spots on the product: detection of black spots on the product.

Presence of powder all around the product: detection of the product’s powder all around the product itself.

MULTI-PRODUCT PACK FOR HARLEQUIN LITE

Multi-product management: possibility to check several products that are

included in the same blister.