ARGO is the automatic Inspection machine for liquid filled infusion containers. A concentrate of up to date technology for particles checking.

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1 INSPECTION MACHINE

2 ARGO is the automatic Inspection machine for liquid filled infusion containers. A concentrate of up to date technology for particles checking. Machine speed up to pch Handled containers: Glass bottles BFS bottles fill sealed Vials

3 GENERAL DESCRIPTION Containers are fed up from motorized belt trays and collected to the first starwheel, where the containers can be controlled in their sealing part (cap/bend/tip), if requested. The conforming ones are charged in the main carousel. Each vial/ampoule is picked up and held by pneumatic grippers fitted with specially shaped pads. This holding system leaves the bottom of the container (underside and bottom shoulder) completely clear, for best illumination and vision. Spinning of each container is performed to put in movement each particle inside product, and completed just before reaching the inspection position, where the cameras take several images of the container and lighting system flashes to perform particle and filling level inspection, and cosmetic control if requested. After that, release of container is operated at good or reject position according with result of all inspections and quality requirements. Machine construction, including safety guards, frames and electrical cabinet are made in AISI 304 SS. CONTINUOUS TRACKING SYSTEM ON MAIN CAROUSEL Cameras and illuminators are placed on a moving system able to follow the carousel movement for some angle in order to provide longer inspection time along with faster production speed and avoid any shacking of containers. TRACKING/INSPECTION RETURNING BACK

4 Infeed screw, starwheels and guides are easily exchangeable for handling different bottle sizes. They are made out of macromolecular polyethylene. Infeed screw is fitted with a safety device which stops machine in case of jamming. Reciprocating motion driven by a servomotor for smooth product handling, with no liquid shaking that would affect inspection quality. Carousel supported from above and having container gripper units, for easy cleaning and access. Easy access to mechanical and electrical equipment. Total access to the vision system, cameras and illuminators, for easier adjustment and maintenance.

5 PARTICLE AND FILLING LEVEL CHECKING for BOTTLES Containers are first spun according with programmed spinning profile. When liquid and particles are in movement, container is stopped and inspected. Acquisition and comparison of several images at high speed and resolution provides the traces and movement of all particles bigger than 30 um. Final analysis of processed images can reject containers according with number and size of detected particles and programmed acceptance/quality criteria. The inspection machine ARGO can be configured with one or two types of light system, in order to handle both glass and plastic containers. State-of-the-art stroboscopic LED lights are used to illuminate the product and provide best image quality and detection performances. Images are analysed to calculate filling level too. Bottom light station (Inspection based on light scatter/ reflection Tyndall Effect) Inspection station aimed to detect particles by detecting light scattered from particles to camera. The use of latest white LEDs provides an extremely bright and collimated beam to avoid container side walls lighting. Suitable to detect even smallest particles, down to 5um. Back light station (Inspection based on absorbed light) Inspection station aimed to detect particles by measuring drop of light caused by particles shadow. More suitable to inspect plastic containers and less sensitive to light reflections caused by oddly shaped containers and to air bubbles. Same system can also check meniscus for floating particles.

6 OTHER CONTROLS Machine can be equipped with additional Controls Check of sidewall to detect dirt, cracks and glass defects Cosmetic control Is performed on the main carousel after particle checking. The container is rotated around his axis so that the complete unfolded sidewall image is acquired and transferred to the computer for processing. Checking of: - dirt, dust, inclusions, stones - chips & cracks in the glass - surface shape irregularities, bumps, ripples - air bubbles included in glass - particles stuck on the sidewall Cap/sealing control Is performed in the first starwheel with dedicated camera and illuminator to inspect the whole neck/cap area. Checking of: - presence, height,shape - flip-off, rubber presence - irregularities on bending, black spots, bubbles - bumps, ripples, cut, dents, scratches -Top/side control - colour Hanger control Performed with dedicated bottom camera to check presence and shape of hanger.

7 CONTAINERS HOLDING SYSTEM Containers are picked and held by neck. Body and bottom of containers are therefore free and can be completely illuminated and inspected for best detection of defects. Grippers rotation is driven by programmable servomotors controlled by the PLC. Proper and consistent spinning is critical to guarantee good and stable inspection performances. All spinning cycle parameters can be precisely adjusted and controlled by software. Quick format change of container gripper pads. No tools are required. Patented Fully automatic height adjustment of carousel by servo assisted screw jack to fit different bottle sizes. The main carousel is supported from the top and columns position allows convenient access to inner area for easiest cleaning and maintenance.

8 HARDWARE AND SOFTWARE SYSTEM All machine systems are based on Embedded Windows XP. Software (automation, safety, vision, HMI) is entirely developed by PHARMAMECH. Virtually any kind of customization, adjustment is therefore possible. Automation, vision and HMI software are CFR21 Part XI compliant. Machine is completely based on Ethernet connection and can therefore be easily connected to existing plant LAN or Supervisor. Automation PLC can be programmed to become the line or plant Supervisor. It can be connected to virtually any existing I/O bus. Connection with SCADA system also available. All components (sensors, motors, cameras, etc.) are continuously checked for faults. Almost all kind of accessories can be connected and used (printers, modems, external HDD or USB pen for backup, etc.). System and application critical files are protected against deletion, modification, copying. No shutdown procedure is required. No loss of data/files in case of power failure. Alarms, warning and all parameters changes are stored on disk. Storage of inspection data and statistics is also available for easier validation/setting up process. Customized batch reports (PDF) and printout. Maximum safety level: CAT 4 (EN 954-1) - SIL 3 (IEC 61508). All the functions can be managed by a convenient and large touch screen. Keyboard and trackball can be added for maintenance and advanced operation. Two IP65 sealed USB and LAN plugs are available for connection with notebook and other functions (backup, print, support, etc.). Remote access available for maintenance, support, assistance. UPS is provided as a standard to protect computers and electronic boards from over-voltages / short breaks.

9 This protocol has been prepared by: SERVICES PHARMAMECH can provide different Services to follow every step of Projects. PRE-SALE AND PROJECT EXECUTION SERVICES Discussion about inspection issues and quality requirements Analysis and Definition on new equipment integration in new/existing line Arrangement of controls and machine setting (problems & solutions study, preliminary tests with samples) Support in URS (User Requirement Specifications) writing Contractual performance definition Project Manager interface Project planning Kick-off meeting and Milestone Meetings with Customer INSTALLATION, COMMISSIONING AND ACCEPTANCE TEST SERVICES FAT (Factory Acceptance Test) SAT (Site Acceptance Test) Mechanical & electric installation (connection to extension of existing conveyors system) Connection with existing plant network, SCADA, supervision Setup of connection for remote control/support, printings, backup & recovery Training (basic and advanced) Validation processes (DQ/IQ/OQ/PQ, Knapp Test, documents filling up) Support for Operational Procedures setup/writing Supply of spare parts for n years INSTALLATION QUALIFICATION PROTOCOL INSTALLATION QUALIFICATION PROTOCOL IQ Device Protocol N Rev. Page INSPECTION MACHINE ARGO IQ MP / 42 Device Protocol N Rev. Page INSTALLATION QUALIFICATION PROTOCOL IQ INSPECTION MACHINE ARGO IQ MP / 42 Device Protocol N Rev. Page INSPECTION MACHINE ARGO IQ MP / 42 Customer Customer INSTALLATION QUALIFICATION PROTOCOL IQ Device Protocol N Rev. Page INSPECTION MACHINE ARGO IQ MP / 42 Customer IQ Customer INSTALLATION QUALIFICATION PROTOCOL INSTALLATION QUALIFICATION PROTOCOL INSTALLATION QUALIFICATION PROTOCOL INSTALLATION QUALIFICATION PROTOCOL Protocol n. IQ MP01043 Protocol n. IQ MP01043 Protocol n. IQ MP01043 Protocol n. IQ MP01043 Inspection machine ARGO Inspection machine ARGO Inspection machine ARGO Glass Vials Line Glass Vials Line Inspection machine ARGO Glass Vials Line Glass Vials Line This protocol has been prepared by: This protocol has been prepared by: Name Title Signature Date Name Title Signature Date Name Title Signature Date Ing. S. Arletti Software R&D Ing. S. Arletti This protocol has been prepared by: Software R&D Ing. S. Arletti Software R&D Name Title Signature Date AFTER SALES SERVICE Spare parts supply Critical spare parts list, availability within 48h Ing. S. Arletti Software R&D Version Emission Date Emission Reason Version Emission Date Emission Reason Version Emission Date Emission Reason 1.0 To approve protocol 1.0 To approve protocol 1.0 To approve protocol To approve results Version Emission Date Emission Reason To approve results 1.0 To approve protocol Verifying of machine operation skills and additional training for machine operator/s Planned maintenance service Emergency service on site, availability within 48h, 24h/7days 24h/7days remote support service Assistance for further validation processes (DQ/IQ/OQ/PQ, Knapp Test, documents filling up) The AFTER SALES service is guaranteed in every Country with Spare parts supply, Maintenance and Training support To approve results To approve results Every service item must be verified and decided together with Customer during defining Project quoting.

10 OUR PRODUCT LINE INCLUDES Automatic and semiautomatic Inspection machines for ampoules, vials, syringes, cartridges, bottles, bags, BFS. Integrity control machines, LK Test Washing/inspection machines Tray and conveyor loading machines Monoblocks (Inspection+LK Test, Inspection+Labelling, Washing, Drying+Inspection) PHARMAMECH PLUS Our Inspection machines can treat different container sizes (small volume containers and large volume containers, BFS, syringes, cartridges, bags) even at high production speeds. Our machines and Controls are tailor-made, studied and adjusted according to Customer needs and special applications. INFORMATION ARE NOT BINDING. - The manufacturer keeps the right to carry out without notice any modification deemed necessary.

11 The dream of every designer, is to realize user friendly machines, with low maintenance costs and long life. Designing in the correct way since the beginning, with passion and perseverance, and maximizing the use of new technologies, the results achieved are surprising. PHARMAMECH SRL Via del Donatore, COLLECCHIO (PARMA) ITALY Tel Fax info@pharmamech.com -

12 04/2011

G.F. S.p.A. Via T. Edison, Rubbiano fraz. Solignano (PR) - Italy Tel Fax Web:

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