Marketing&Communication Department Via Nazionale 100, Pianoro (Bo) Italy

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1 Marketing&Communication Department Via Nazionale 100, Pianoro (Bo) Italy Press Release Marchesini Group at Achema 2009 Marchesini Group, a worldwide leader in the field of automatic machines and complete lines for packaging pharmaceuticals and cosmetics, will attend Achema 2009 in Frankfurt from the 11 th 15 th May with cutting edge machinery designed for the liquid and solid product market, c/o Hall 3.1 Stand O32 Q41. The Group will exhibit some of its leading products for the liquids market: in the limelight will be the new ampoule line made up of the continuous rotary washing machine for ampoules WRA24 8, the new sterilization tunnel with cold chamber NLT60S C and the ampoule filling sealing machine RSF24 with 8 dispensing pumps. Another role leader will be a vial line made up of the ML616 machine, the labeller (BL400) and the continuous cartoning machine (MA305). The monobloc high speed ML616 machine that fills and caps glass syrup vials has 12 filling heads and 8 capping heads and also avails of a statistic control system with reject of non compliant products. For the syringe market, the Group will exhibit machine model FSP10, for filling and closing disposable sterile syringes pre arranged in BD Hypack systems or equivalent systems, in an aseptic environment. Spotlights will focus on the worldwide preview of Marchesini s brand new robotic line Unica that is able to integrate the two deep forming and carton packaging functions in just one monobloc unit: this solution features 100% robotic feeding systems. The stand alone machines will also comprise an ampoule labeller BL600 by Neri and, for creams, the tube filling machine model Millennium120 produced by Tonazzi Vasquali with its easily detachable and cutting edge dispensing unit. As for the solids market, the role leader will be Integra 300, an integrated robotic blister line that incorporates the two thermoforming (blistering) and carton packaging processes in just one monobloc unit, offering a production rate of 300 blisters/min. There will also be room for the MT1000 tablet tubing machine, which clearly changes the concept of filling rigid tubes, and also for Compact 12, a compact and integrated monobloc filling, counting and capping machine produced by Vasquali Tonazzi that processes tablets, coated tablets and capsules. As proof of Marchesini s commitment towards the topic of serialization of pharmaceutical products, the group will take the opportunity of the Achema 2009 event to present two versions of the new labelling machine BL400; this machine applies and checks tracking codes of pharmaceutical products and also labels with different code combinations.

2 Page 2 of 11 First of all will be machine model BL400XL, which prints and then checks Datamatrix codes on an impressive three positions (top face and two flaps of the carton). The other solution on show will be the high speed machine model BL400VTEXL, which not only prints Datamatrix codes on the top face and the two flaps of the carton, but may also fit up to three labelling heads to apply vignette labels on the top face and two corners of the carton (Tamper Evident). Legislations concerning the serialization of pharmaceutical products will shortly be enforced in various countries around the world and Marchesini Group is ready to offer its international customers specific purpose designed solutions that have already been tested with the aid of major multinational enterprises and also others: modular machines that can be integrated in existent packaging lines. Complete lines for all packaging requirements For packaging liquids NEW The new ampoule line New depyrogenation tunnel with sterilisation of the cooling chamber Versatile, fast and reliable line Among the lines manufactured by Marchesini Group dedicated to liquids, role leader at Achema 2009, will be the new ampoule line consisting of the continuous rotary washing machine for ampoules WRA24 8, the new depyrogenation tunnel with sterilisation of the cooling chamber model NLT60S C and the ampoule filling sealing machine RSF24, equipped with 8 dispensing pumps. The leader of the line is machine model WRA 24 8 produced by Corima, a continuous rotary washing machine for ampoules and vials with gripper conveyance system. The external parts of the machine are made of stainless steel, the rigid parts in contact with the washing fluids are made of stainless steel AISI 316L and finally the flexible parts are made of rubber approved for pharmaceutical use. The machine offers important features: 1) Automatic loading: automatic selection and transfer of the containers to the conveyance grippers by means of a loading star wheel. 2) Internal and external washing and drying: the cleaning cycle, which can exploit three different fluids, is made up of 8 internal cleaning stations of the containers, two of which are installed on this machine (Water for Injectables WFI and Compressed Air). The needles raise and penetrate the container and, following the continuous motion, they each perform their own washing or

3 Page 3 of 11 blowing functions. The sequence of cleaning fluids to be used can be chosen based on the specific process requirements, keeping the circuits strictly separate. 3) Control of the cleaning fluid spray time: the opening times of the feeding valves of each washing fluid can be programmed from the operator panel and enable the optimisation of fluid consumptions. 4) Automatic unloading: by means of an unloading screw with continuous motion. The washing machine is then connected in line to the new depyrogenation tunnel with sterilization of the cooling chamber, model NLT60S C produced by Neri that belongs to a new series of depyrogenation tunnels with laminar flow of hot air for ampoules or vials, having amongst other functions, also the peculiar function of automatically sterilizing the cooling chamber. The cooling chamber is sterilized by a flow of air heated by a special set of heating elements made of stainless steel AISI 316 L, installed within the circulation lines. The depyrogenation tunnel and the cooling chamber are both insulated with double walls to guarantee thermal isolation from the external environment. While the cooling chamber is being sterilized, to save Energy, the hot air circulation system automatically works in recycle mode. During the sterilization cycle of the cooling chamber, the outlet of the tunnel is automatically shut off by a hermetically sealed hatch, which separates the inside of the machine from the sterile chamber or from the isolator. The tunnel is equipped with an automatic compensation system of pressure peaks in the sterile chamber, which is automatically disabled during the sterilization function of the cooling zone. A silicone Hepa filter is installed in the cooling chamber, for high temperatures, which can work continuously under a flow of air at 250 C. How does the tunnel work? The cooling chamber is sterilized when the tunnel has completed the normal treatment of a batch of ampoules or vials. The sterilization process of the cooling zone (time/temperature cycle) is set on the Operator Terminal and is programmed to guarantee the correct sterilization of the whole cooling chamber, especially points in which it is quite difficult for the flow of hot air to reach, which are consequently normally colder. The probes that control the heat regulation function are installed in these points. During the sterilization cycle of the ampoule or vial cooling zone, the probes that control the process must ensure that the minimum temperature of 170 C is reached and held at such level for the whole time necessary to reach a bacterial reduction of 6 Log. The sequence of the sterilization cycle of the cooling chamber is completely automatic and is performed as follows: the insulated ampoule outlet hatch is closed, which separates the tunnel from the sterile chamber; the sealing gasket of the hatch is inflated with sterile compressed air; the liquid in the cooling battery is drained; the by pass that recycles the air is opened; the air expulsion line is closed; the heating elements are switched on: the set temperature is reached and is held for the time required to ensure correct sterilization. When the sterilization cycle of the cooling chamber is complete, the recycling by pass is automatically shut off and the hot air expulsion line is opened again; in this way, the temperature

4 Page 4 of 11 lowers gradually and, at the end of the cooling phase, the machine is ready to receive the ampoules or the vials again to be depyrogenated. Finally, the ampoules are fed to the ampoule filling sealing machine RSF24, produced by Corima; this versatile, fast and reliable machine is equipped with 8 dispensing pumps and is very easy to service and clean. The machine features cutting edge technical solutions to meet the highest of quality standards in the pharmaceutical industry: studied and designed to ensure the highest levels of cleanability of machines for this market, model RSF24 guarantees maximum effectiveness of the air flows used to protect the product during the filling phase. All exposed parts are made of stainless steel AISI 316 or they are made using plastic materials suitable for the requirements of the workplace. Special care was also taken in designing the feeding circuits of the sealing gases in order to satisfy the highest of European safety requisites. Servo motors are used to drive the main movements of the machine because they guarantee versatility and repeatability of all the functions assigned to the machine and to its control system. Some of the movements driven by servo motors worth a mention are those of the dispensing needles, of the pumps, of the flames and those of the grippers that tear off the glass trims, because these are indeed the movements that control the two main functions of the machine: on one hand, product dispensing during the filling phase and on the other, closing and forming of the tip of the ampoule during the sealing phase. These solutions not only guarantee the perfect repeatability of the functions carried out, but also ensure the possibility to process liquids with special chemical physical characteristics or glass containers with just as unusual characteristics. NEW UNICA, the new robotic monobloc line Compact, fast, ergonomic and innovative Robotic feeding units: Robovision is the role leader Spot lights are on Marchesini s stand, during Achema 2009, for the worldwide preview of Unica, the latest creation of Marchesini, which has the same philosophy as the robotic monobloc unit Integra. Unica is able to integrate the deep forming and carton packaging processes in one monobloc unit: the solution features totally robotic feeding units. Just like Integra (the monobloc blister line), Unica is split up into two sections the thermoformer and the cartoner each of which are managed by their own stand alone PC. Manufactured entirely with balcony structure in total compliance with GMP standards, the line is designed around three basic concepts: versatility, ergonomics and maximum efficiency in a very compact space. Ease of access, ergonomic stations and maximum visibility of all the units make the line very easy to clean, without forgetting the vertical wall that clearly separates the mechanical area from the work area.

5 Page 5 of 11 Outstanding novelties are represented by the feeding units which, compared to Integra, feature two Robovision machines, being robots with four axes developed entirely by Marchesini Group to pick up products, syringes or other products from a belt and to feed them to the thermoformer and also to the cartoner. Maximum layout flexibility, a large work area and precision are the main features of this brand new product: a revolutionary system that offers extreme flexibility and considerable reduction in cleaning and size changing times. Characterised by cutting edge technical solutions and a balcony structure, the thermoformer is able to produce very deep containers, for both cosmetics and pharmaceuticals. The machine offers some very important features: a pitch of 160 mm for an absolutely ample forming area; a brushless motor that powers the main drive of the machine with main shaft and cams; special attention has been paid to size changing, which is performed without using tools, thanks to quickrelease couplings and locking handles. As for the packaging of the containers in cartons, the machine allows the operator to carry out management procedures, such as loading the cartons and the leaflets in just one access area. The product and the cartons are conveyed by special toothed belts, while the cartons are picked up and opened by oscillating arms. The winning feature of the new monobloc lines of Marchesini Group Integra and Unica is indeed versatility, which is enabled by the ever increasing use of robotic solutions. Size changing is simple and rapid and guided entirely by the PC. The line is able to process up to 150 cartons/minute. Vial line Maximum flexibility Precision dosing Another role leader will be a vial line made up of the ML616 machine, the labeller (BL400) and the continuous cartoning machine (MA305). The monobloc high speed ML616 machine that fills and caps glass syrup vials has 12 filling heads and 8 capping heads and also avails of a statistic control system with reject of non compliant products. The ML616 is a high speed single block rotary machine for filling and capping bottles, equipped with a 12 station filling head and a 9 station capping head. A high performance machine with maximum flexibility, precision dosing and extremely compact dimensions, the ML616 structure is made easy to clean by the absence of dead angles and edges. This modular machine is made in several versions according to different packaging requirements: for filling only, capping only or for filling and capping bottles. The filling section has centralised head height adjustment, simultaneous adjustment of the syringes and the volume to be dosed and a drainage tube for collecting any liquid under the filling zone. Bottles are conveyed by quickcoupling self centring pick up grippers which grip the bottle neck. The absence of lifting plates guarantees maximum bottle cleanness.

6 Page 6 of 11 Volumetric filling can be set up with ceramic or stainless steel valves and syringes with a seal, using rotary piston valve syringes or ceramic or stainless steel tube squeezing valves and syringes with a seal. The syringes are rapidly removed without tools, for washing and sterilising. The syringe control is enclosed in the base, avoiding the risk of cross contamination. The machine is designed to allow installation of a CIP (Clean In Place) or SIP (Steam In Place) unit, whilst in the capping section the closing heads have different combinations depending on the types to be applied and may be with or without rotation. Labelling machine BL400 Machine model BL400, produced by Neri, is an ergonomic linear labelling machine, fast and reliable. The machine applies a label around the sides of vials and cylindrical containers made of glass, metal or plastic. The ergonomics of this machine are designed to enable all adjustments, replacements of the label reels, of the printing tapes and of the size parts on the controls side, to make all the operator s jobs extremely easy. The machine can work in line with other packaging machines or as a stand alone unit with special feeding devices and equipment that re processes the vials. Cartoner model MA305 At the end of the line is MA305 continuous motion cartoner, an extremely versatile machine, built with a balcony structure to allow full visibility and inspection, with completely separate mechanical zone and product and carton conveyor zone. This feature permits total and easy identification and removal of any residues at the end of a batch. Products arriving from the feed chain conveyor are inserted by a set of pushers located on the side opposite the operator, which track the continuous motion of the carton chain conveyor, whilst the cartons are fed forward by motor driven tracks. For packaging solid products Integra300: integrated robotised blister line Compact: thermoforming and cartoning in a single block Ergonomic and versatile Robocombi: integrated robotised connection Compact, fast, ergonomic, innovative. INTEGRA300 is the integrated robotised blister line from Marchesini Group. This latest design blister line can integrate in a single block the two operations consisting of thermoforming and packaging in cartons. The line is divided into two sections, each controlled by its own independent PC, and is extremely compact. Built entirely with a balcony structure in full compliance with GMP standards, it was designed around three basic concepts: versatility, ergonomics and maximum efficiency with limited dimensions. The extreme accessibility and ergonomics of all of the stations and maximum visibility

7 Page 7 of 11 of all units allow immediate line cleaning, not forgetting that a vertical stainless steel wall guarantees separation of the mechanical zone from the working area. The line has an integrated robotised connection, the Robocombi, a solution which picks up each blister and places them directly in the cartoner buckets, without any intermediate steps. This flexible solution from Marchesini helps to make the new line one of the most modern robotic creations in the pharmaceutical packaging sector. As regards blister packaging in cartons, the machine allows the operator to control operations such as carton and leaflet loading, recovery of good, complete blisters in the line in a single access zone. The cartons, picked up and erected by oscillating arms, are conveyed using special toothed belts. Another superb feature of Integra is the size change over, simple and fast thanks to the possibility of retrieving the product parameters from the PC. The line can handle 300 blister /min. and 150 cartons/min. Stand alone machines Solids, Liquids, creams, track & trace solutions NEW Etichettatrice BL400VTEXL (track & trace) Affidabilità e massima precisione per l applicazione e il controllo di codici per la tracciabilità di prodotti pharma e di etichette Ergonomica e versatile In view of the enforcement of serialization legislations for pharmaceutical products in various countries around the world, Marchesini Group offers the market some specifically designed solutions, which have already been tested in collaboration with major multinational enterprises and also others, and which are already used in production facilities in a number of countries: they are modular solutions that can be also easily integrated in existent packaging lines. As proof of Marchesini s commitment towards the topic of serialization of pharmaceutical products, the group will take the opportunity of the Achema 2009 event to present two versions of the new labelling machine BL400; this machine applies and checks tracking codes of pharmaceutical products and also labels with different code combinations. First of all will be machine model BL400XL, which prints and then checks Datamatrix codes on an impressive three positions (top face and two flaps of the carton). The other solution on show will be the high speed machine model BL400VTEXL, which not only prints Datamatrix codes on the top face and the two flaps of the carton, but may also fit up to three labelling heads to apply vignette labels on the top face and two corners of the carton (Tamper Evident).

8 Page 8 of 11 The advantages of the machine, which has already met with success on the international market, are many. First and foremost, it is a machine with balcony structure, ergonomic and completely accessible, which facilitates cleaning and management, plus the operator has a full view of the whole production process. The labelling machine works in steps, which guarantees maximum application precision of the label and the final result, plus size changing is precise and quick. Finally, this machine rejects non compliant products and works at a very high speed (450 cartons per minute). There is also a version for marking and checking flat carton blanks before they are erected, which can be installed off line (BL400VA). FSP10 syringe filling machine Speed: 24,000 syringes/hour Balcony structure and brushless motors The Co.Ri.M.A. FSP10 is a machine able to fill and close, in a sterile environment, disposable sterile syringes prepared in BD Hypack or equivalent systems. The machine has several significant technical solutions, including use of the balcony structure and all construction solutions facilitating air flows to protect the product, the system for moving nests to the loading station which prevents any risk of contact with the lower ends of the syringes, the centring system used to insert caps, for avoiding contact between the surfaces of the syringes and the cap insertion systems. The FSP10 fills and closes up to 24,000 disposable syringes/hour and was designed and meet current Good Manufacturing Practice (cgmp) requirements and for RABs (Restricted Access Barrier system) technologies. Amongst the optional systems for this machine are those for injecting inert gas during filling and capping (patented system ensuring perfect isolation of the cap from contact with the air before it is put in position) and steam cleaning (CIP) and sterilising (SIP) in place for the whole dosing system. Not forgetting the use of brushless motors for all machine movements, motors which provide precision and adaptability for all mechanisms, plus management of filling and closing processes with products which have special chemical or physical properties. Labelling machine BL600 Maximum accessibility and ergonomic arrangement of all the units making up the machine Speed: up to 600 pieces per minute Simple and fast size change Produced by Neri, machine model BL600 is a high speed machine that applies self adhesive labels on ampoules, vials or other round containers. Featuring maximum accessibility and particular attention to ergonomics, machine model BL600 is able to process up to 600 pieces per minute.

9 Page 9 of 11 The labelling machine has a positive transport system with variable pitch that ensures fail safe operation and a balcony structure with ergonomic arrangement of all the units making it up. All the operational, mechanical and electrical zones are perfectly separate. The transport roller conveyor with variable pitch is able to process a wide range of sizes with possibility of automatic size change, which can be set on the operator terminal. Size changing is consequently very easy and fast. Cleaning and maintenance are also quite simple. Millennium 120 tube filling machine Speed: 120 tubes/min. Removable dosing unit Balcony structure, highly ergonomic Marchesini Group s answer to tube filling requirements is the Millennium 120 made by Tonazzi Vasquali, with a dosing unit that can be removed in an easy, innovative way. Second in line after the successful Millennium version, this single channel tube filling machine achieves speeds of 120 pieces/minute. Designed for installation under a laminar flow hood, this machine features simultaneous installation of metal/hot air closing systems, resulting in maximum flexibility and modularity with fast size change overs. The dosing unit is removable: all of the connectors for parts in contact with the product are Tri Clamp and the whole unit (consisting of hopper, valve, piston and nozzle) can be extracted and easily transferred to the washing and sterilising area. Size change over adjustments are centralised, controlled by a servomotor and can be activated directly from the PC on the machine. The tubes are conveyed on special self centring holders. A movement controlled by a brushless motor lifts the tube holders towards the dosing nozzle, guaranteeing perfect filling from the bottom. This method prevents pockets of air from remaining in the tube, even with difficult products and at high speeds. The machine has a balcony structure, allowing maximum accessibility for inspection of the drive units and from the operator side for cleaning and adjusting all units and components. MT1000: the new rigid tube filling machine Compact tube feed system Revolutionary tube filling system Ergonomic, innovative, revolutionary: MT1000 is a tube filling machine for tablets which clearly changes the concept of filling rigid tubes. The tubes are conveyed in holders with synchronised dynamic motion. Tablets are inserted using a revolutionary positive pick & place system; a compact tube feed system guaranteeing space saving. The machine structure has no sharp edges, hidden points or recesses where dust or product fragments can gather. Its design prioritises the need for a clean, uncontaminated environment.

10 Page 10 of 11 The lower part of the feed and filling station was deliberately left open, so that the dusts generated can fall to the ground, and there is a centralised extractor system. All of the main machine operations are driven by brushless motors. The tube feed and orientation system is much more compact than the normal existing systems: the tubes are fed loose and tube orientation is handled automatically using a system of plates which feed the tubes up towards the feed belt. A screw feeder between the tube arrival belt and the pick up device makes the tubes arrive in the correct position for loading. The tube is then picked up, placed directly in the chain and held securely in the conveyor holder. The tube carrousel has two parallel belts, each with an independent motor, to which 4 sets of 12 tube holders are hooked. The 4 sets of tube holders are located at units in which the main operations are carried out: tube loading, tube filling and cap loading. Thanks to the fact that they have their own motors, making them independent of one another, the two belts each move a pair of sets of tube holders. This system with synchronised dynamic motion eliminates tube stops between one operation and another, making the whole process smoother and more continuous. The tablets are conveyed on a belt from which they descend towards the feed channels, so that they are arranged vertically. A robot with 12 arms equipped with suction cups picks up a row of 12 tablets at a time, turns them through 90 degrees and places them directly in the tubes. This tube filling system is truly revolutionary. This is positive transfer, which brings many advantages: the tablet is constantly accompanied, never left on its own; the tablet is not subjected to friction or pressure, instead its integrity is preserved by avoiding any rubbing which could result in damage; pick up and counting are guaranteed and controlled directly by the machine PC. Finally, size parameters can be set on the PC: the stroke is variable and is automatically calculated, to minimise friction and impacts. NEW Compact 12 Integrated monobloc tablet filling, counting and capping machine Maximum accessibility This machine is a compact and integrated monobloc filling, counting and capping machine produced by Vasquali Tonazzi that processes tablets, coated tablets and capsules. The machine integrates an electronic counter with 12 channels and a capping unit for producing up to 60 vials/minute: the integration of the two machines enables amazing advantages in terms of compactness and cleaning in the filling zone. The machine is indeed originally pre arranged to integrate an isolator containment system for protecting the operator, or laminar flow systems for protecting the product. The vial inlet and outlet at the back guarantee accessibility on three sides of the machine. The management logics of the two machines are perfectly integrated in the industrial Siemens or Allen Bradley PC, equipped with large colour touch screen display.

11 Page 11 of 11 Assisted program setting and a sophisticated trouble shooting system offer complete yet simple control of all the machine functions. All types of capping systems can be installed (screw on, presson, crimped). Finally, the large area available at the front enables additional functions, such as the insertion of silica gel, cotton or sponge. For more info: Marchesini Group Press Office Mrs Manuela Goldoni ( ) Mr Guido Rossi ( ) press.office@marchesini.com