ASEPTIC PROCESSING
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Catalog excerpts

ASEPTIC PROCESSING - 1

SMALL VOLUME PARENTERAL CONTAINERS ASEPTIC PROCESSING

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INTERNAL WASHING | WR Series DEPYROGENATION | DEPYR Series FILLING & STOPPERING | STERY Series CONTAINMENT | ISOL-AIR Series ALU CAPPING | CAPSY Series EXTERNAL DECONTAMINATION | WRE CODING | CODY 02 | AMPOULES 18 FILLING & SEALING | RSF Series 03 | DISPOSABLE SYRINGES 22 BAG CUTTING & TUB PEELING OFF | FREETUB Series 24 FILLING & STOPPERING | FSP Series 25 DE-LIDDING, DE-LINING, FILLING & STOPPERING EXTRAFILL Series

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WE AT MARCHESINI ARE PROUD LEADERS IN MANUFACTURING AND INTEGRATING COMPLETE LINES SINCE 1974. WE PRODUCE STAND-ALONE MACHINES AND COMPLETE LINES TO HANDLE THE ENTIRE PACKAGING PROCESS FOR THE PHARMACEUTICAL AND COSMETIC INDUSTRIES. Following the acquisition of CO.RI.MA. in 2003, we became a leading company offering complete lines for injectable products in pre-filled syringes, vials and ampoules, from the washing process of the primary container to resting the final packed product on the pallet. The Marchesini Group combines CO.RI.MA’s proven experience in machine production for sterile...

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Balcony-style facilitates innovative line installation, containers can be transported without friction, and cleaning surfaces is simple and easy. All machines comply with GMP and FDA Wall installation enables maintenance to be carried out from the back-side of the machines in a non-classified technical environment. New models are constantly being developed in our High-speed machines provide solutions aimed at reducing total changeover time and maximising the pharmaceutical process performance. Fully automated In Process Controls and containment cabinets in Isolation Technology have been...

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SMALL VOLUME PARENTERAL CONTAINERS VIALS

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PACKAGING PROCESS PRIMARY PACKAGING SECONDARY PACKAGING INTERNAL WASHING INTERNAL WASHING BUNDLING BUNDLING FREEZE-DRYING (machine by third party) EXTERNAL DECONTAMINATION PLASTIC TRAY PACKAGING PAPER BOARD TRAY PACKAGING VISUAL INSPECTION (machine by third party) TRAY PACKAGING INTO CARTON The above chart illustrates the complete Marchesini line, whereas the contents of this catalogue detail the primary packaging machines. For information on secondary packaging and end of line machines, visit our website www.marchesini.com 7

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MACHINE SOLUTIONS INTERNAL WASHING WR SERIES Rotary continuous motion machines for internal washing and drying of ampoules and vials for Small Volume Parenteral (SVP). • 8 internal and 3 external washing/blowing stations • Pre-washing in Ultrasonic Bath • Water Recycling • Automatic drainage and drying • Container siliconizing OUTPUT 3.000 / 24.000 pcs / h PRODUCT RANGE Ampoules 1 ml / 25 ml Vials 2R / 500 ml

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DEPYROGENATION DEPYR SERIES Depyrogenation Tunnels for ampoules and vials for Small Volume Parenteral (SVP). • Hot chamber with dedicated make-up unit and air-flow control • Automatic balancing and air flow adjustment • Pressure cascade according to process requirements • Outfeed chamber with dedicated cooling coil and 100% air recycling • Dry-Heat sterilization of outfeed chamber OUTPUT 3.000 / 24.000 pcs / h PRODUCT RANGE Ampoules 1 ml / 25 ml Vials 2R / 500 ml

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MACHINE SOLUTIONS FILLING & STOPPERING STERY SERIES Filling and stoppering machines for liquid or lyo products, suitable for filling vials for Small Volume Parenteral (SVP) in an aseptic process with complete or partial closure using rubber stoppers. • Intermittent or continuous motion • Balcony or traditional table-top arrangement • Statistical or 100% weight check In Process Control (IPC) • Dosing system: rotary piston and/or peristaltic pumps • Inert gas flushing • Easy integration with RABS or Isolator • Cleaning and Sterilization in Place (CIP/SIP) Featured Model: STERY-LC OUTPUT 3.000...

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Featured Model: STERY-LA Featured Model: STERY-SA 11

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MACHINE SOLUTIONS CONTAINMENT ISOL-AIR SERIES Containment cabinets suitable for product and/or operator protection within aseptic processes. • Closed RABS or Isolation technology • Bio-decontamination with Vaporized Hydrogen Peroxide (VHP) • All types of aseptic transfer connections available • Environmental Monitoring (EM) devices • Bag-IN / Bag-OUT filters • Washing in Place (WIP) • HVAC Air Handling Units (AHU) Featured containment type: Closed RABS

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ALU CAPPING CAPSY SERIES Alu Cap sealing machines for liquid or lyo products, suitable for closing vials for Small Volume Parenteral (SVP) in an aseptic process. • Intermittent or continuous motion • Balcony or traditional table-top arrangement • Automatic Sealing Pressure Regulation • Low particle generation • Easy integration with RABS or Isolator Featured Model: CAPSY-LC OUTPUT 3.000 / 24.000 pcs / h PRODUCT RANGE Vials 2R / 500 ml MADE BY CO

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MACHINE SOLUTIONS EXTERNAL DECONTAMINATION WRE Rotary continuous motion machines for external washing and drying of ampoules and vials for Small Volume Parenteral (SVP). • Cabinet and duct washing with spray-balls and manual spray-guns • Automatic drainage and drying • Dedicated detergent circuit • Bag-In / Bag-Out filters OUTPUT up to 24.000 pcs / h PRODUCT RANGE Ampoules 1 ml / 25 ml Vials 2R / 125 ml MADE BY CORI

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CODING CODY Continuous motion machines for printing codes on vials or caps/seals with camera verification. • Different code printing positions possible - shoulder, body or bottom of vials; lateral or top side of caps/seals • Vials transferred by a screw to main starwheel for coding and checking operations • Vials are held by vacuum systems in the main starwheel to ensure uniform printing and maximum control precision • Printing head and camera height automatically adjusted from the HMI • Vial collection in trays OUTPUT up to 24.000 pcs / hr PRODUCT RANGE Cartridges 1ml / 3 ml Vials 2R / 500...

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SMALL VOLUME PARENTERAL CONTAINERS AMPOULES

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PACKAGING PROCESS PRIMARY PACKAGING SECONDARY PACKAGING INTERNAL WASHING PLASTIC PACKAGING TRAYS LABELLING CARTONING PAPERBOARD PACKAGING TRAYS LABELLING EXTERNAL DECONTAMINATION VISUAL INSPECTION (machine by third party) LABELLING The above chart illustrates the complete Marchesini line, whereas the contents of this catalogue detail the primary packaging machines. For information on secondary packaging and end of line machines, visit our website www.marchesini.com 17

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