MAR, THE RIGHT SOLUTION FOR YOUR PHARMACEUTICAL FILLING PROJECTS.

MAR, THE RIGHT SOLUTION FOR YOUR PHARMACEUTICAL FILLING PROJECTS.

M.A.R. is a leading Italian Company manufacturing liquid and powder machines for the pharmaceutical field. Our Company started with the production of semi automatic machines for laboratories and small batches, more than 40 years ago and nowadays our machines range includes solutions for vials, cartridge and syringes - in nest and out of nest - covering different speeds up to 600 vials per minute, as well as customized complete lines from washing machines to end of line equipments. In the 70 s M.A.R. was the first company to realize a machine with a statistical check-weighing system and in the early 90 s the first project under isolator was achieved. In all these years, M.A.R. has dedicated itself to a constant research and development of innovative solutions, achieving the efficiency flexibility and versatility of the technology supplied. Our sales structure is based on an agency network located all over the world, where some agencies supply direct assistance to Customers while in other countries the Assistance Service is provided by M.A.R. itself, with two commercial offices in India and USA. Thanks to our network, M.A.R. covers major markets like Europe, North/ South America, and Asia, achieving an extensive reference list. M.A.R. is the right solution for your pharmaceutical projects

M 19 M19 INTERMITTENT MOTION FILLING AND CAPPING MONOBLOC LIQUID FILLERS for Generic 5 The M19 is an intermittent motion monobloc liquid filling machine for speeds up to 100 vials or bottles per minute. This M.A.R. model is ideally suited to the production of products such as parenteral, ophthalmics as well as syrups and nasal sprays, etc., and it can be installed under isolator technology. The machine is suitable for small bottles which require filling and up to two other operations which can be stopper insertion and aluminum over-sealing, plug insertion and screw capping or dropper insertion and other combinations. Ophthalmic application There are two versions: a) with all operations carried out around a central star-wheel; b) with filling heads inline along the infeed conveyor. The positive pick and place heads use vacuum to accurately transfer and locate the closing element. The machine is able to reject incomplete or incorrect vials. Filling in line, capping operation in star-wheel S U I T A B L E F O R : generics ophthalmics injectables

LIQUID FILLERS for Generic 7 M 26 M26 LINEAR FILLING MACHINE M 12 M12 CAPPING MACHINES M.A.R. M26 linear filler represents the most traditional filling system which can handle different liquid products for the pharmaceutical or cosmetic field, thick liquids, solutions, suspensions, etc. The M26 peculiarity is the capability of filling foaming products with smooth results deriving from diving nozzle moving system. Filling syringes units is controlled with servo-motor drives. directional rotary seal-less and valve-less volumetric syringes or ceramic syringes suitable for CIP/SIP operations or peristaltic pumps are available. Maximum production output = 400 pieces/minute based on 12 dosing pumps and for fill volumes up to 5 ml. The M26 filler can be installed under isolator technology and RABS. Continuous motion capper M12 is able to apply aluminum caps, Pilfer- Proof caps, screw-caps, press-on caps and plastic pumps at speeds ranging from 80 to 600 pieces/ minute. Machines for plug insertion perform this operation by vacuum. Torquing of screw-caps can come with magnetic or pneumatically operated clutch. Sealing of pharmaceutical aluminum caps for injectables with fixed blades acting on rotating vials with pressure control. Machine is suitable for installation under isolator conditions. Adjustment and control of the closing parameters by HMI. The machine can be equipped with 2, 4, 6, 8, 10 or 12 filling syringes, which configuration can be chosen according to the speed required. Versions with AISI 316L SS uni- Pilfer-Proof sealing is achieved with traditional style spinning head. Sealing with fixed blades S U I T A B L E F O R : generics ophthalmics injectables Torquing station (magnetic clutches)

LIQUID FILLERS for Generic 9 M 47 M47 ROTARY FILLING AND CAPPING MONOBLOC Double capping station The M47 is a continuous motion monobloc machine to fill pharmaceutical liquid products at speeds up to 400 pieces per minute. The machine is particularly suitable to fill and cap bottles with a combination of rubber plugs, screw-caps, aluminium caps and pilfer proof caps. Glass or plastic containers can be filled with different product types such as drinkable solutions or syrups. Versions with 10, 12, 16, 20, or 24 filling heads and 5, 8, 10 or 12 heads can be supplied to carry out a combination of plugging, torquing or sealing. The machine incorporate adjustment for fill volume and capping head settings from HMI using servo motors. CIP system is included. M.A.R. also proposes a version of the M47 monobloc for filling operations, only. The M47 is also suitable to handle cosmetic products for high speed outputs. Front view of filling station S U I T A B L E F O R : generics

LIQUID FILLERS for Ophthalmic 11 M 53 M53 IN-LINE FILLING AND CAPPING MONOBLOC Working line M.A.R. double pitch intermittent motion machine model M53 represents great innovation in pharmaceutical packaging machine design. This latest machine model offers the capability to handle glass and plastic bottles and vials, droppers of different styles, rubber stoppers, etc.; as well as closures, which include different types of screw-cap and aluminum cap applications. Bottle (or vial) transport is carried out by mean of a walking beam comb system that moves the bottles through the machine without the use of a belt or star-wheels to eliminate particles generation. All operations are performed in-line. The M53 machine dimensions have been reduced to an absolute minimum for installation under isolator technology, and is specifically designed to allow maximum laminar flow if placed under a HEPA filter system. The base machine can be completed with: Automatic plastic bottle feeding and unscrambling systems and/or infeed tables for glass containers; Loading hoppers for the continuous supply of caps, stoppers, etc.; 100% IPC check-weighing system. M53 operating speeds range from 60 up to 120 pieces/minute. Ophthalmic application S U I T A B L E F O R : generics ophthalmics injectables

M 52 M52 IN-LINE FILLING AND CAPPING MONOBLOC FOR OPHTHALMICS Nitrogen tunnel after filling LIQUID FILLERS for Ophthalmic 13 The drop cap unit is placed on the first main star-wheel of the machine and will be dedicated to the feeding, application and insertion of the droppers on filled bottles. The screw cap unit is placed on the second main star-wheel of the machine and is suitable to apply screw-caps onto filled/plugged bottles. M52 has been specially designed and developed to suit the market needs for filling and capping operations of ophthalmic under RABS, crabs or isolator conditions. The model M52 is a continuous motion machine carrying out in-line filling, plugging and capping operations for ophthalmic products, capable to achieve a max. speed up to 350 p/minute. The in-line filling unit is positioned along the vial transport plastic material belt, with manually interchangeable inserts. S U I T A B L E F O R : generics ophthalmics The hoppers and the vibrating bowls are enclosed on a st.st. structure and guarding with gloves used for the dropper/screw-cap bags supporting and stocking prior their opening for feeding to the feeding hopper. This is done to reduce at the minimum the particle contamination. Capping unit detail

M 50 M50 FILLING AND CAPPING MONOBLOC FOR OPHTHALMICS LIQUID FILLERS for Ophthalmic 15 The M50 for ophthalmics can be equipped with 3 4 or 8 AISI 316L SS uni-directional rotary piston sealless and valve-less syringes, ceramic syringes to stand CIP/SIP automatic cycles or peristaltic pumps. Filling and plug capping movements are very smooth and the lack of fast rotations dramatically lowers the level of particles This version of M50 can also handle non-ophthalmic plastic or glass bottles, at this speed. It can also be manufactured in the version suitable for spray-pumps insertion (nasal spray pump type) as well as for aluminum pumps insertion. In this case, it comes with the crimping station with mechanical system. Working desk Speed ranges from a minimum of 150 p/minute (model equipped with 3 filling needles) to a max of 350 p/ minute (model equipped with 8 filling needles). Some M50 machines for ophthalmics have been installed under isolator. Capping unit Caps feeder S U I T A B L E F O R : ophthalmics generics

M 53 M53 COMBO MONOBLOC FOR VIALS AND PFS LIQUID FILLERS for Parenteral/vials Working desk under isolator 17 PFS loading by chute The model M53 Combo is a double pitch filling/stoppering and capping monobloc capable to handle both PFS and vials at 120 p/minute based on 2 ml. vial and 1 ml. syringe. The equipment is suitable for injectable products under RABS or isolator and the transport is made by a walking beam comb system, which reduces particles contamination to minimum level. The machine can also treat lyo products. In this case, the rubber stopper is partially inserted into vial. As an option, it is possible to install a 100% or statistical IPC checkweighing system. In addition, M53 is also available in a Small Batch version which can achieve a max speed of 60 p/minute based on 20 ml. vial and 30 p/ minute based on 1 ml. syringe. PFS filling The stopper/plunger are fed from a vibrating bowl, then inserted into a star-wheel and pushed on vial/pfs neck. Vial loading by turnable Sealing unit Vial filling S U I T A B L E F O R : injectables

LIQUID FILLERS for Parenteral/vials 19 M 39K M39-K DOUBLE PITCH MONOBLOC FOR CARTRIDGES High view M39-K is a double pitch monobloc machine, which provides dosing and capping operations by moving two cartridges per time, up to 120 p/minute. The machine is suitable to handle cartridges from 0.5 to 10 ml. Cartridges loading and unloading is by means of compact in-feed and out-feed trays. The bung is inserted by mechanical system, while the sealing of the aluminum cap on cartridges is realized by means of crimping heads. The machine is pre-arranged to include a SS or glass ball into cartridges. Filling syringes are rotary piston seal-less and valve-less style, made from AISI 316LSS or ceramic with the possibility to use also ceramic syringes to stand automatic CIP/SIP cycles or peristaltic pumps. Working desk S U I T A B L E F O R : injectables

LIQUID FILLERS for Parenteral/vials 21 M 50 M50 FILLING MONOBLOC FOR INJECTABLES Stoppering station The M50 is a continuous motion machine for the production of injectable solutions and injectable suspensions performing up to 420 vials/minute. The pitch of vials, which are very close one to another, and the dosing/ stoppering cycle allow the M50 to be amongst the most efficient equipments for the extreme reduction of particles contamination, according to the different elements used. The M50 machine can be equipped with the following filling systems: AISI 316L SS uni-directional rotary seal-less and valve-less volumetric syringes; Ceramic uni-directional rotary seal-less and valve-less volumetric syringes suitable for CIP/SIP operations; Peristaltic pumps and comes in the following versions: With three dosing units at a speed up to 150 pieces/minute, With six dosing units at a speed up to 300 pieces/minute, With eight dosing units at a speed up to 420 pieces/minute. Application with statistical IPC check-weighing system can also be provided. The application of a Nitrogen purging unit is also available in order to reduce the oxygen level in extreme conditions. Many machines are installed under isolator technology and RABS. Statistical check-weighing unit S U I T A B L E F O R : injectables

M 52 M52 IN-LINE FILLING AND STOPPERING MONOBLOC FOR LIQUIDS LIQUID FILLERS for Parenteral/vials 23 Stoppering unit The model M52, in-line continuous motion filling machine for liquids (solutions and suspensions) has been specially designed and developed to suit the market needs for filling and stoppering operations to be carried out under isolator or RABS conditions. The dimensional advantages, ease of change and simplicity in use make this model one of the more appreciated machines from the M.A.R. range. The machine filling system can be equipped with AISI 316L SS unidirectional seal-less and valve-less volumetric pumps which can stand automatic CIP/SIP cycles. Peristaltic pumps filling system is also suitable. A special system for vial transport by a single plastic material belt and manually interchangeable Arnite inserts is completed without the need for tools. Statistical IPC checkweighing system can be provided. The stoppering station uses vacuum through an AISI 316 SS wheel to pick and place the stoppers continuously. Height adjustments are external from the machine, fixed pre-set points covering the size range are set by hand-wheels. Check weighing unit, CIP/SIP filling unit under isolator Working desk The M52 is available in different versions, 4S, 6S, 8S and 12S achieving speed up to 600 pieces/minute. S U I T A B L E F O R : injectables

LIQUID FILLERS for Parenteral/syringes 25 M 54 M54 FILLING MACHINE FOR NESTED VIAL/ PFS/CARTRIDGES PFS nest filling unit The M54 allows the processing of nested ready to use vial, PFS and cartridges in one unit. The M54 is capable to receive components by loading open tubs directly into the loading area. The fully automated working cycle includes the pick-up of the nest from the tub, the filling cycle, the stoppering cycle, and re-positioning the nest into the tub. The machine is electronically driven by means of brushless motors. The machine can be quipped with 2 or 5 or 10 (two or five or ten) rotary seal-less and valve-less filling syringes that might also be supplied in ceramic (to stand CIP/SIP automatic cycles) or peristaltic pumps, in addition the equipment can be completed with all the extras/options that might be required for this application. Filling operations are carried out in one step (2 or 5 or 10 components are filled per time) and each dosing needle will deliver 100% of fill volume into each syringe. The stoppering station includes a vibrating bowl and linear chute, which handles 2, 5 or 10 bungs per time, which are pushed into the component from pushing rods. The M54 machine can be completed as a fully automatic line adding our OBM (Opening Bag Machine) and OTM (Opening Tub Machine). The operator can set up the machine accordingly by himself within the scope of a form change. Customer make a quick change within 30/40 minutes. Output of the machine is up to 150 syringes/minute based on 1 ml PFS size (5 filling syringes), 300 syringes/ minute based on 1 ml PFS size (10 filling syringes). Vial nest Stopper feeding bowl Working desk S U I T A B L E F O R : injectables

POWDER FILLERS M41/DP M41/DP POWDER AUGER DOSING AND CAPPING MACHINE Dosing & capping units 27 The M41 Auger Machine is designed to carry out volumetric dosing of powder or fine grain products and is especially designed for the pharmaceutical industry using a high precision electronic device which is easily set. Auger dosing technology makes this machine particularly flexible and adaptable for most types of powders and particularly difficult products. It is also suitable for handling special containers with several dispensing and closing elements, such as the anti-asthmatic products. Up to four different dosing heads can be installed on the same mechanical group: Model DP/1 for doses from a few milligrams up to 10 grams; Model DP/2 for doses from 10 grams up to 100 grams. Fill accuracy, depending on fill volume and product features is within +/- 0,5% and +/- 1%. These heads are fed through a rotary valve complete with pneumatic control. All product contact parts are made from AISI 316SS and are quickly detachable for easy cleaning and sterilizing operations. The M41 Auger Machine is particularly suitable for installation under isolation technology. The M41 Auger Machine capacity is up to 100/150 pieces/minute. DP/2 filling unit Sealing unit

POWDER FILLERS MM24P /2S MM24P/2S VACUUM/PRESSURE POWDER FILLING AND STOPPERING MONOBLOC 29 The dosing system has been developed with the capacity to fill single or multiple dosages into the same vial. The monobloc is equipped with a feeding system to fill two bottles per time. This machine is fed through a rotary valve complete with pneumatic control. A micrometric adjustment allows to reach an important accuracy on dosage between ports. Application with 100% IPC checkweighing system. Machine runs at 300 p/minute. Incomplete/incorrect vial rejection system provided. The MM24P/2S is a compact intermittent motion machine suitable to fill sterile powder using the vacuum/pressure system. The two dosing discs, 24 ports total, which have the capacity adjustable between 0.180 and 3.2 cc. contains sintered SS filters used to retain the powder into the port while the vacuum is present inside the port itself. The monobloc machine is realized to reduce footprint with high performances. Dosing disc detail

ACCESSORIES M33 FOR BOTTLE BLOWING M33 unit is specifically designed for bottle blowing operations. Bottles are fed on a turntable and then transferred to the blowing wheel entrance, placed in a vertical position relative to the turntable. This wheel rotates inverting the bottle. Bottle cleaning operations are carried out during the vertical rotation for a fixed time. The bottles return into a vertical position to bottle exit. Achievable speed is up to 60 bottles/minute based on 50 ml. bottles. MSC CONTINUOUS MOTION MACHINE FOR BLOWING MSC high speed continuous motion machine for blowing and vacuum extraction of bottles for pharmaceutical use. Two versions available: - Equipped with 10 bottle holding grippers and 10 needles reaching an output up to 150 bottles/minute; - Equipped with 20 bottle holding grippers and 20 needles reaching an output up to 300 bottles/minute. Bottles are inverted by means of Arnite grippers. Blowing-vacuum needle are inserted into the bottle. Bottle feeding from stainless steel mesh conveyor or from in-line conveyor. MTR TURNTABLES FOR BOTTLE FEEDING AND ACCUMULATION MTR can be manufactured with different diameters: 800 mm. 1.000 mm. and 1.200 mm. Some versions are equipped with perforated disc and with particulate aspiration under the turntable. Other versions with external feeding disc and central hole to improve the deflection of the laminar flow. Any turntable diameter can be combined with sterilizing tunnels, with a control system for min/max load. Versions for installation under isolator are also available. M21 SINGLE OR DOUBLE TRAYING UNIT M21 is a single or double unit to collect vials into trays. An electronic system is used to orderly vials into rows at quincunx. If it is a double tray loader when the first tray is full the vials are directed to the second tray and vice versa. This enables continuous operation. All safety devices are included, such as full tray non replaced. Versions for installation under isolator are available. Maximum operating speed = 400 vials/minute (configuration with two trays). OTM/OPENING TUB MACHINE OTM is a unit to open tubs for disposable syringes. Basically the machine includes: - A robot cycle to remove lids - A station for waste material - A discharge station for empty tubs. Machine has a small footprint and can easily be installed under Laminar Flow, crabs or isolator. Speed: from 10 tubs/minute and up. DSM/DENESTING SYRINGES MACHINE DSM is a machine to automatically remove syringes from nest. Syringes are picked-up, row by row, by a servo-controlled system. Then, they are deposited into a linear vibrating chute which will transfer them out of the DSM area, to feed them to down-stream machines. This machine is proper for installation under Laminar Flow, Rabs, crabs and isolator.

ISOLATORS Since 1990 M.A.R. has offered complete Isolators and Restricted Access Barrier Systems (RABS) as another Advanced Aseptic Processing solution. In addition M.A.R. supplies crabs and ISOLATORS, equipped with systems for product manipulation and transfer, allowing operators to work with the safety of an absolute barrier and provide a controlled atmosphere for the product. orabs crabs and ISOLATORS control systems are developed in accordance with FDA, cgmp, GAMP and 21CFR Part11 requirements.

AUTOMATIC PROCESSING LINE Sequence of operations Vials loading Linear or Rotary Vial Washing machine Vial Sterilization and Depyrogenation Vial Buffering Vial Filling and stoppering optionals Processing freeze-dried stoppers and normal stoppers Vial tray loading Fully automatic in-process control (IPC) Pre-post Nitrogen gassing Sealing Laminar Flow / RABS system or Isolator External Washing (Cytotoxic products) 3 4 2 1 1. Linear washing machine 2. Sterilization and depyrogenation tunnel 3. Soft touch or turntable 4. Filling and Stoppering machine with fully automatic IPC

M.A.R. Macchine Automatiche Riempitrici s.p.a. Viale Italia, 50 20020 Lainate (Milan) ITALY Phone: +39 02 93 75 37.1 Fax: +39 02 93 75 37 41 E-mail: infosales@margroup.it www. margroup.it MAR USA, Inc. 80 Oak Street Norwood, NJ 07081 Phone: +1 201.750.1944 Fax: +1 201.750.1966 E-mail: maffeis.alberto@marmachines.com www.marmachines.com MAR India Pvt. Ltd. Survey No 66, Plot No. 18, Near IPOL, Village Waliv, Vasai (East). Dist.: Thane 401208. Maharashtra, India Phone: 0091-250-3980238 E-mail: sales@mar-india.com www.marmachines.com