S T E R I L E F I L L I N G

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2 As an internationally active, innovative, intelligent and futureoriented company, in a constantly changing market, we need to open new paths. SFM is a company that combines state-of-the-art technology and services. SFM offers innovative, application-oriented and user-oriented technology and combines it with service and reliability. Our service concept distinguishes SFM from others.

3 With several references worldwide SFM proved its reliability in different sterile and non-sterile filling applications for the pharmaceutical industries. Customer benefit and customer satisfaction are our primary goals. All problems are solved in the best possible way in close cooperation with our customers. This is how SFM develops processing systems that guarantee top performance and ensure long-term customer satisfaction.

4 FILLING MACHINES FOR PHARMACEUTICAL APPLICATIONS The modern design of SFM filling, stoppering and capping machines takes into consideration the newest requirements of the filling process: In line transport and small width, suitable for the application of RABS and isolators, reduce the volume to be monitored and sterilized; Continuous monitoring of the viable and non viable particles; Filling by peristaltic pumps and volumetric pumps actuated by brushless motors, that allow precise filling volume and easy adjustment of the pumps by means of the HMI; Nitrogen blowing inside the vials before, during and after the filling; 100% IPC (In Process Control) of the weight and statistical Check Weighing system with feedback to the dosing pumps; Possibility of performing prefilled syringes, loaded from the nests; Vibration generator for the bowl of stoppers inside the mechanical volume, below the process area; Capping designed to reduce particle generation, by rotating the vials under the blades.

5 Sterile Filling Aseptic processing in particular is regulated by GMP and FDA guidelines as well as other directives which provide the foundation for the concept and design of our production systems. Vials SFM vials filling machines type VFM handle from 2ml to 100ml vials with minimal format changes and with production speeds up to 400 vial/min, according to vial size and filling volume. The filling machines are equipped with an in-feed rotating table which feeds empty vials into the walking beam system. The pumps in the filling section fill correct volume into the vials. Filling operations are carried out in two steps by means of stainless steel dosing nozzles mounted on an AISI316L stainless steel support. To avoid foaming, the filling system utilizes diving nozzles that, during the filling operation, is retracted upward. Each vial can be individually weighed before and after filling to get the net the fill weight. A feedback control loop can also be provided to automatically adjust the filling volume of each individual filling pump. For high speed filling machines, a statistical check weighing system is foreseen. Vials proceed to the stopper inserting station where stoppers are fed by a vibratory feeder bowl to the stoppering unit. VFM50 VFM100 VFM200 VFM300 VFM400 Up to 3.000/hour Up to 6.000/hour Up to /hour Up to /hour

6 Ampoules SFM ampoules filling and sealing machine is a linear filler suitable to process 4, 6 or 8 ampoules at each machine cycle, according to the required output. The machine has been designed following the criteria typically needed in aseptic environments, such as, reduced dimensions, geometry facilitating the unidirectional airflow, high ergonomic level, slim design. The very accurate constructive concepts allow the machine to condition ampoules at high speed: up to 400 ampoules/min and the possibility to handle both open and closed ampoules. A combi version is also available to match ampoules and vials filling. The filling of ampoules is carried out by means of volumetric pumps even if the machine can be equipped with other filling systems typical of aseptic operations as Time/Pressure or Peristaltic Pumps. The sealing station consists of two stations with different burning temperatures (according to the ampoules glass thickness). The machine is equipped with the gas shut off system in case the flames failure. AFM200 AFM300 AFM400 Up to /hour Up to /hour

7 Cartridges The design of the SFM KFM series complies with the GMP and US FDA regulations. This machine performs the following operations: Cartridge infeed to the working area through an infeed star-wheel. Lower positioning of the bung. Introduction of mixing balls. Gas flushing before filling process. Filling. Closing of the cartridge with an aluminum cap and rubber stopper. Accumulation of the cartridge to the next machine or operation. As all other SFM machines also the KFM type is equipped with servo motor drives. The filling is done in two steps to avoid introduction of air in the cartridge. The filling can be performed either with volumetric- or peristaltic pumps. The closing station is equipped with a crimp head, which achieves a minimum generation of particles during the closing process. The changeover to a different size can be carried out quickly, easily and without tools, by exchanging complete sets of size parts. KFM50 KFM100 KFM200 Up to 3.000/hour Up to 6.000/hour

8 Combined filling Thanks to the GMP conform modular design of SFM machines certain filling and closing stations can be arranged in one single machine platform. This advanced design enables SFM to combine i.e. Ampoule and Vial filling in one common base machine in order to customize the process. Combined filling machines perform: Vials and Syringes Vials and Ampoules Vials and Cartridges Vials Syringes and Cartridges VSFM model VAFM model VKFM model VSKFM model

9 Syringes SFM filling machines SYFM series performs Pre Filled Syringes (PFS) from 1ml to 20ml, with minimal format changes, and with production speed up to 200 PFS/min. The walking beam transports the PFS through the pre-gas station, the filling station and the post-gas station. In the bung insertion station the star-wheel handles bung stoppers fed by a vibratory feeder bowl and special double pistons insert the bung stoppers into the PFS. Incomplete syringes, without bung stopper, will be automatically rejected. SYFM50 SYFM100 SYFM200 Up to 3.000/hour Up to 6.000/hour Opthalmic The SFM OFM series is an intermittent motion filling and closing machine with a wide performance range. It is suitable for dosing volumes from 0.25ml to 100ml with a speed of up to 200 bottles/min. The machine is supplied with different dosing systems (volumetric pumps with gravity valves, front or rotating valves, 2 or 3 piece cylinder valves, time/pressure filling system and peristaltic pumps) and a large number of closures can be applied, too. The OFM is used to pack pharmaceutical products, from syrups to oral and nasal drops. No bottle/no fill device is available, as well as filling needles with pneumatic cut-off system, capping pressure control, screw-capping with torque control. The machine is built in AISI 304 or AISI 316L and fully cgmp compliant. OFM50 OFM100 OFM200 Up to 3.000/hour Up to 6.000/hour

10 Nest Syringes The SFM NFM series is a filling and stoppering machine for ready-to use, disposable syringes in nests. The filled and stoppered syringes in the nests are automatically re-inserted into the tubs to be taken to the next step in the secondary packaging process. The machine can be equipped with volumetric pumps or with other filling systems typical of aseptic operations as Time/Pressure or Peristaltic Pumps. CIP/SIP system is available on request. The NFM series is fully equipped with brushless motors to reach maximum flexibility in handling and filling accuracy. Syringes according to ISO NFM 100 Number of Syringes per Nests Syringes/h 0,5 and 1 ml long ,5 and 1 ml long , 2 and 3 ml ml ml ml Syringes according to ISO NFM 200 Number of Syringes per Nests Syringes/h 0,5 and 1 ml long ,5 and 1 ml long , 2 and 3 ml ml ml ml

11 Non-Sterile Filling Bottle Filling The SFM BFM series is an intermittent motion filling and closing machine with a wide performance range. It is suitable for dosing volumes from 0.25ml to 500ml with a speed of up to 100 bottles/min. The machine is supplied with different dosing systems (volumetric pumps with gravity valves, front or rotating valves, 2 or 3 piece cylinder valves, time/pressure filling system and peristaltic pumps) and a large number of closures can be applied, too. The BFM can also be used to pack pharmaceutical products, from syrups to oral and nasal drops. No bottle/no fill device is available, as well as filling needles with pneumatic cut-off system, capping pressure control, screw-capping with torque control. The machine is built in AISI 304 or AISI 316L and fully cgmp compliant. BFM 50 BFM100 BFM200 Up to 3.000/hour Up to 6.000/hour Container Filling The SFM CFM series is an intermittent motion filling and closing machine with a wide performance range. It is suitable for dosing volumes from 0.25ml to 100ml with a speed of up to 200 bottles/min. The machine is supplied with different dosing systems (volumetric pumps with gravity valves, front or rotating valves, 2 or 3 piece cylinder valves, time/pressure filling system and peristaltic pumps) and a large number of closures can be applied, too. The CFM can also be used to pack pharmaceutical products, from syrups to oral and nasal drops. No bottle/no fill device is available, as well as filling needles with pneumatic cut-off system, capping pressure control, screw-capping with torque control. The machine is built in AISI 304 or AISI 316L and fully cgmp compliant. CFM 50 CFM100 CFM200 Up to 3.000/hour Up to 6.000/hour

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