HARLEQUIN BLISTER AND PHARMACEUTICAL KIT INSPECTION HARLEQUIN EVOLUTION LITE

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Chester Geoffrey Williams
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HARLEQUIN BLISTER AND PHARMACEUTICAL KIT INSPECTION Harlequin is the vision system dedicated to blister and thermoforming machines for the inspection of oral solids and pharmaceutical components.

In order to simplify the system self-programard Tool that allows the operator to regulate both working formats and article parameters for products packaged in plastic material (white PVC,

2 HARLEQUIN BLISTER AND PHARMACEUTICAL KIT INSPECTION Harlequin is the vision system dedicated to blister and thermoforming machines for the inspection of oral solids and pharmaceutical components. The Software works under Windows 7 (64 bit) and uses cutting-edge hardware devices PCBased Quad & Octa core CPU s, very high resolution cameras and LED light units with custom-design. In order to simplify the system self-programard 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) HARLEQUIN EVOLUTION LITE and scalability. Harlequin Lite is the system Entry Level vertechnical INFORMATION: Unlocked HMI panel during automatic work Image reconstruction for a complete object view Graphical Oscilloscope for signal error debugging SVM (SEA Vision Machine): integrated virtual PLC for machines rejection management Compliant to FDA 21 Cfr Part 11 Harlequin Evolution is a complete vision inspection system, able to manage at the same time more packaging machines, and to grant many additional checks (thanks to multifunction cameras) such as: barcode and 2D codes reading on cartoners, on line printed variable data with integrated printer management, printing artworks checks (PQV) from digital/flexographic printers.

3 Difference in area <4% Difference in area <8% CPU: Quad core OS: Windows 7 Application: 64 bit Touch Screen Ram up to 8 GB Hmi unlocked during the automatic work Interface: Ribbon Style CPU: Dual core OS: Windows 7 Application: 64 bit Touch Screen Ram 2 GB Hmi locked during the automatic work Interface: classic Difference in lenght<4% Broken or chipped tablet<4% Difference in lenght <8% Broken/chipped tablet <5% with Simmetry pack * MEASUREMENT ACCURACY (GEOMETRICAL) LCD TFT size: 12 Interface: Touch screen or trackball I/O BASE: 16 input + 16 output opto-coupled at 24V, watch-dog on outputs I/O OPTIONAL: 24 input + 24 outputs opto-coupled at 24V, watch-dog on outputs LCD TFT size: 12 Interface: Touch screen or trackball I/O BASE: 16 input + 16 output opto-coupled at 24V, watch-dog on outputs I/O optional: 24 input + 24 output opto-coupled at 24V, watch-dog on outputs 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 MEASUREMENT ACCURACY (PICTORIAL) Light: LED Neon: no Supports BACKLIGHT for tray inspection: optional (COMPONENTS PACK*) Light: NEON LED: optional Doesn t support BACKLIGHT for tray inspection Wizard for the self programming of the single product Wizard for the self programming of the multiproduct Cross check parameters/ articles Optional (Components pack*) Wizard for the self programming of the single product Wizard for the self programming of the multiproduct SPECIAL SOFTWARE FEATURES Max cameras per Harlequin: 4 Tv 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: 2 Tv Alucode with special Dome light for barcode or 2D check on aluminium foil: 1 only Alucode Image resolution and depth: standard 768 x 576, RGB 24 bit Integrated 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 Integrated PLC functions for the reject without additional devices Real time display of the Shift Registers Graphic oscilloscope for signal error debugging REJECT 4

4 BLISTER (tablets, capsules, ecc...) TRAY (vials, syringes, needles, kits, ecc...) Area (Number of pixel of the object) BLISTER (tablets, capsules, etc...) TRAY (vials, syringes, needles, kits, etc...) with limitation: No multiproduct management WEB TYPE Area (Number of pixel of the object) User access FDA 21 CFR PART 11 compliant Alarms on signals Events logged into a file Audit trails Colour Colours Shape 1 and shape 2 Shape 3 and shape 4: simmetry Black spots on the product Presence of powder around the product 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 *) Multi-product management Double tablet Fragments in cavity Product out of cavity MEASURED PARAMETERS Multi-product management (Multiproduct pack*) Double tablet optional (Extra-check pack*) Fragments in cavity optional (Extracheck pack*) Product out of cavity optional (Extra-check pack *) Direct modem connection Internet connection to SEA Vision server 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 Foil splice (Extra-check pack *) Dirty foil optional (Extra-check pack*) Check of the machine step optional (Extra-check pack*) Alucode optional EXTRA CHECKS According to GAMP4/5 rules

The software also performs a chromatic measurement of the object color, black spots detections on the

Check of presence, colour, and integrity on tablets/ capsules packaged on ALU-ALU material.

CHECK OF WHITE CAPSULES ON WHITE PVC Presence, colour and defects checks on products packaged in

BLU/TRANSPARENT CAPSULES IN BLISTER Presence check on blue/transparent capsules in blisters.

CHECK OF CAPSULES ON PVC Presence, color and integrity check of the capsule packaged in a PVC blister.

The colour accuracy is then granted by a double chromatic check, independent from the capsule position,

5 The software also performs a chromatic measurement of the object color, black spots detections on the product surface and tablet mix-up inside the same blister. Check 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 WHITE CAPSULES ON WHITE PVC Presence, colour and defects checks on products packaged in transparent PCV (clear or coloured). BLU/TRANSPARENT CAPSULES IN BLISTER Presence check on blue/transparent capsules in blisters. The control also verifies the double presence of products in the same cavity. CHECK OF CAPSULES ON PVC Presence, 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. CHECK OF TABLETS ON TRANSPARENT PVC CHECK OF TABLETS AND CAPSULES ON ALU-ALU BLISTERS AND PHARMACEUTICAL KIT INSPECTION 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.

CHECK OF COMPONENTS IN TRAY Check of the different components placed in the

CHECK OF COLOUR RINGS ON AMPOULES Check of presence and colour of rings on

The software allows the pixel sizes and the distance of ring 3D CHECK OF

cavity filling. With a 3D measurement of the powder inside the cavity.

through the measurement of the distance between a fixed point of the

6 CHECK OF COMPONENTS IN TRAY Check of the different components placed in the pharmaceutical tray and packaged in white or transparent PVC, and in cartons. CHECK OF COLOUR RINGS ON AMPOULES Check of presence and colour of rings on ampoules. The software allows the pixel sizes and the distance of ring 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 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. CHECK OF CASE FORMING FOR COMPONENTS INSERTION Check of correct case forming and positioning of components BLISTER IMPURITIES CHECK Check of impurity on blisters with the usage of backlights placed under the blister.

CHECK OF CASE FORMING This application verifies the correct

Count of vials in box (or inside cartons).

blister forming and filling (verification of the correct

VIALS COUNT Licenza Software: Misure Programmabili BLISTERS

7 CHECK OF CASE FORMING This application verifies the correct case forming, and detects possible non compliant packages. Count 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). VIALS COUNT Licenza Software: Misure Programmabili BLISTERS AND PHARMACEUTICAL KIT INSPECTION CHECK OF TRANSPARENT SYRINGE S PLUNGER ROD PRESENCE IN CASE Presence check of the transparent syringes plunger rod included in the cases.

8 SEA VISION S.r.l. Via Folla di Sopra Pavia (PV) Italia Tel

Blister. Packaging Machine.

Blister. Packaging Machine. www.jbmptp.com Blister Packaging Machine The best of service with the highest quality machine for long term business. Our mission is to develop and maintain mutually beneficial relationship with our customers