XTREMA HIGH SPEED FILLING & STOPPERING MACHINE

XTREMA HIGH SPEED FILLING & STOPPERING MACHINE

XTREMA HIGH SPEED FILLING & STOPPERING MACHINE FOR TIME HAS COME TO TAKE CONTROL This is the refrain that has driven IMA Life to further innovate. State-of-the-art constructive details coupled with consolidated and worldwide reknown filling technology, make of NEW XTREMA Series the latest technological breakthrough in aseptic filling. Designed with a modern modular concept, XTREMA gives the possibility to actively manage the production process, by tailoring the different machine phases to the actual production needs. XTREMA is an in-line filling & stoppering machine with positive in-line transport system. The machine is suitable for filling liquid solutions into cylindrical vials and for the insertion of rubber stoppers and can handle all vial sizes in the SVP range: from 0.10 to 100 ml and the LVP range up to 1000 ml.

A SEPTIC ENVIRONMENTS The XTREMA complete range of machines offers wide flexibility and modularity according to the production requirements. And offers the possibility to integrate modular equipment, providing the adaptability required by the productive process. From the top of the range full optional machine to simpler versions to satisfy production needs. XTREMA is available in the following versions: Continuous motion filler with or without statistical IPC for up to 600 vpm Intermittent motion filler with or without 100% IPC up to 400 vpm Continuous/intermittent motion filler, selectable from HMI, for up to 600 vpm or with 100% IPC still at 400 vpm. Due to the high degree of modularity the machine can be installed even in reduced space environments; wall installation or right to left machines are also available. Different vial in-feed and out-feed options are available according to the speed and the dimension of the vials to be handled.

XTREMA INNOVATIVE DESIGN Differential pumps Peristaltic pumps HIGHLY INNOVATIVE DESIGN DETAILS harmonized with the extreme ergonomics of the machine result in improved cleanliness and ease of accessibility. A key focus of XTREMA s design is the great flexibility that the machine can offer due to the possible integration of modular equipment, providing the adaptability and customization that pharmaceutical companies need when developing new production concepts. ANTROPOMORPHIC ROBOTIZED NOZZLE CARRIER To fulfil the latest cgmp regulations and requirements for isolation integration, all mechanical movements should not come in-andout of the grey area, in order not to contaminate the product being processed and to reduce the risk of leaks. The IMA Life anthropomorphic robotized nozzle carrier fully responds to this design requirement: similar to the human body motions, the fluid of the motion ensures as well, no vibrations and gentle handling of the vials. The nozzle carrier motion is driven by servo motor offering high flexibility in filling operations.

XTREMA DOSING SYSTEMS INNOVATIVE VOLUMETRIC DIFFERENTIAL PUMPS NEW MATERIALS COMBINED WITH REVOLUTIONARY ASSEMBLY TECHNIQUES Volumetric, differential dispensing pumps, suitable for CIP/SIP, based on a new design concept. The filling pumps are equipped with a QUICK FIT revolutionary type of assembly technique, which allows a very easy fitting and dismantling of the pumps without tools, and without touching the product contact parts. Thanks to the new cgmp design (exclusively for IMA Life), and Mass flow dosign system the outer shell in plastic material the pumps are also very light to handle and particularly ergonomic. XTREMA can be equipped with other filling systems typical of the aseptic operations such as: - time / pressure - peristaltic pumps - disposable filling units - mass flow All these systems can be assembled on the same support and changed according to the product to be handled and the stored recipes. The change from peristaltic to volumetric filling system is simply carried out by HMI. The assembly is simple and quick with lock/unlock system by HMI. XTREMA CAN BE EQUIPPED WITH CIP/SIP SYSTEMS, PARTICULARLY ADVANCED AND EFFECTIVE, PROVIDED WITH PROGRAMMABLE AUTOMATIC CYCLE, WITH NO NEED FOR COMPONENT REMOVAL. IDEAL FOR APPLICATIONS IN ISOLATION TECHNOLOGY.

XTREMA VIAL TRANSPORT SYSTEM SPEED AND FLEXIBILITY: AN INNOVATIVE VIAL TRANSPORT SYSTEM The transport system is linear and positive and allows the conditioning of vials in multi-pocket dowels, which allocate several vials, reducing, in this way the number of dowels to be changed over. The multi-pocket dowels are attached to the carrier system and are very easy to dismantle without tools assuring a very quick size change-over and extreme cleanliness of transport mechanism. The dowels are made of a special plastic material which enables direct exposure to the sterlization gas agent. To reduce particle generation the vials are positively transported on the st.st. belt throughout the whole machine length without friction of the vial bottom. Vial puck quick change over The containers are gently transported throughout the machine up to the stoppering station. The new linear transport conveyor runs vertically, as well as all the other component movements. This helps the unidirectional air flow over the entire machine and therefore on the vial mouths. The round design of the anthropomorphic arm also assures a vertical air flow and no turbulence.

XTREMA HIGH SPEED STOPPERING Lifting platform HIGH SPEED STOPPERING STATION The stoppering station includes a st.st. 316L vibratory bowl feeding the stoppers directly on to a stoppering carrousel with vacuum-operated heads. The vacuum distributor in st.st. and Rulon 641 easily removable and autoclavable. The stoppering head is automatically height adjustable by means of servo motor. Ideal for the processing of plug style stoppers and lyo stoppers. Pre-feeding of stoppers is smooth from the hopper to the sorting bowl to reduce particle generation and distribution. Stopper placement on the vials is performed by a horizontally operating vacuum wheel. Automatic height adjustment of sorting bowl and stoppering head by servo motor, without tools. Continuous stopper feeding from vibratory bowl. Lifting platforms to elevate the vials for stoppers pick up. Stopper confirmation presence on carousel and stopper presence & height check on vial.

XTREMA IN PROCESS CONTROL OF FILLING VOLUME 100% IPC Check-Weighing System BUILT-IN VERSATILITY WITH SOPHISTICATED IPC SYSTEM The Total Ipc system for distributed volume is based on the dual potentiality offered by the machine to select the vial transport motion according to the required production: high-speed at continuous motion and low to medium speed at intermittent motion. The XTREMA offers the possibility to fill at high-speed and simultaneously achieve 100 % check-weighing sampling of an alternate filler with a rate of 400 Vpm, the highest available on the market. The selection from continuous to alternate motion is automatic by HMI. The IPC system removes the vials in batches from the conveyor system for tare and gross check-weighing and then feeds the vials back into the empty dowels. If a deviation in the filling volume is detected, the PC feedback software automatically adjusts the dosing unit. The Total Ipc system is of course also available on the intermittent motion machines up to 400 vpm. Available for the Intermittent motion or Intermittent/Continuous configurations High speed: up to 400 vpm - Tare and Gross check with 6 loading cells each station Detail of load cell Time saving: reduced accumulation of vials at machine downstream. A so called periodic check can also be achieved on this machine version when it s necessary to check only a pre-defined number of vials (typically at batch start and at batch end). The number of vials to check is entered directly on the HMI. During the rest of the production the machine works at the highest speed. Overall accuracy of the system in working conditions is +/- 15-20 mg.

XTREMA CONTROL SYSTEM Statistical IPC Tare Weight Statistical IPC Gross Weight A Statistical Ipc system is available on the continuous motion machines. In this case the machine carries out a vial sampling by removing one vial at a time and feeding it back after the checkweighing. During the weight detection the machine moves at the highest speed. With statistical calculated frequency, the group automatically picks up the container before and after dosing and places it onto the load cells for weighing (tare-gross weight). Available for the Continuos motion configuration High speed: up to 600 vpm - Tare and Gross check with 1 loading cell each station Sampling plan up to 3% Settable sampling sequence. OPERATOR FRIENDLY HMI The XTREMA machines are equipped with a very user friendly touch-screen PC based HMI. The control panel, fitted on a swinging arm, assures easy graphic surfing among the various machine operations and direct access to the maintenance information. Direct management of all machine motion controls via PC HMI. The machine software has been developed according to the GAMP4 guidelines and is 21 CFR Part 11 compliant. Multilevel configurable password system. Easy machine troubleshooting and teleservice also available.

XTREMA BARRIER TECHNOLOGY GREAT DESIGN FLEXIBILITY, OFFERS THE POSSIBILITY TO INTEGRATE MODULAR EQUIPMENT, PROVIDING THE ADAPTABILITY REQUIRED BY THE PRODUCTIVE PROCESS AND IMPROVING CLEANLINESS AND EASY ACCESS. Thanks to the ergonomic positioning of the operating groups and the geometry facilitating the unidirectional airflow, XTREMA is ideal to be exposed to VHP sterilization gas agent (Hydrogen Peroxide in Vapour Phase). Ergonomic displacement of operating groups Geometry facilitating the unidirectional air flow (UAF) Completely sealed by inflatable gaskets Ideal to be exposed to VHP (Hydrogen Peroxide in Vapour Phase) HMI friendly interface with easy accessible location Isolated filling line XTREMA is therefore particularly well suited for installations under any type of installation or layout: traditional clean room RABS (Restriced Access Barrier System) Barrier Isolator Wall installation Left to right vial flow (standard version) * Right to left vial flow (mirror version).

LARGE VOLUME PARENTERALS: XTREMA LV Mass flow dosing system back view XTREMA LV (LARGE VOLUME) SERIES The XTREMA LV (Large Volume) series is conceived and designed to fulfil Large Volume Parenterals (LVP) requirements. Exactly like the standard version, this configuration can be integrated in complete filling lines, from vial washer up to (and including) the freeze-dryer equipment and the alu capping machine. Even this machine configuration is absolutely fit for integration under containment technology, such as crabs and Isolation systems, as well. Based on a MASS FLOW measurement system, the machine is suitable for large volume fillings from 100 ml up to 1.000 ml. The mass flow dosing system (equipped with 8 mass flow meters) is designed for any process requiring high-speed and high accuracy dosing. A rapid changeover with easy- to- clean hygienic design facilitates CIP SIP operations thus contributing to keep a very low particle generation level. 100% IPC Periodical check: numbers of vials directly entered on the HMI CIP-SIP System Mass flow dosing system with integrated-pinch valve-brushless control fills

100% IPC detail 100% IPC Checkweighing facility of filled weight composed by: 4 load cells for net weight sampling before dosing; 4 load cells for gross weight sampling after dosing; two anthropomorphic arm (one for each cell group) for vials positioning on loading cell

XTREMA FULLY INTEGRATED SOLUTIONS Powder filling system Liquid filling system MULTIPLE FILLING SYSTEMS CAN BE INSTALLED ON SAME MACHINE FRAME (E.G.: LIQUIDS & POWDERS) TO BE USED ALTERNATIVELY. THIS FEATURE OFFERS GREAT ADVANTAGES IN TERMS OF FLEXIBILITY OF USE. The XTREMA is ideal for integration into complete aseptic processing lines, whether or not under isolator or RABS. IMA Life offers the complete processing solutions from vial washer freeze dryer and unloading systems. Full harmonization of electrical and mechanical components, conveyors, guarding, LAF units, RABS or isolators, gloves, RTP ports, and last but not least, the same control systems. Combined testing & validation approach. Total responsibility of the line lies with only one Project Manager, thus facilitating the project to stay on track.

XTREMA TECHNICAL DATA XTREMA - CONTINUOUS / INTERMITTENT MOTION - 8 PUMPS - TOTAL IPC 1350 3529 980 2005 2005 2131 2131 655 1350 655 1350 655 1475 655 1475 Example of machine layout 1350 3529 980 XTREMA - CONTINUOUS MOTION - 4 PUMPS - STATISTICAL IPC 1350 2759 980 1350 2759 980 Example of machine layout XTREMA - LV 3000 Example of machine layout 7000 XTREMA & XTREMA LV SERIES Vial diameter 14 101 Vial height 30 231,6 Stopper diameter 13 33 Stopper height - 25 Filling dosing unit Up to 12 Filling Volume Output Output with 100% IPC Transport system Min. 0,10-1000 ml Up to 600 vpm Up to 400 vpm Intermittent motion Continuous motion (Xtrema, only) Intermittent/Continuous motion (Xtrema, only) Max.

December 2014-991XTR2001 www.ima-pharma.com IMA S.p.A. reserves the right to make any changes to the described machine characteristics. IMA S.p.A. IMA LIFE division Via Emilia 428-442 - 40064 Ozzano dell Emilia (Bologna) - Italy Tel. +39 051 6514111 - Fax +39 051 6514666 mktg.life@ima.it - www.ima.it