Innovation for sterile applications

Innovation for sterile applications

The sterile line for vials reconfirms Marchesini Group as a role player in the highly interesting sterile packaging segment of the pharmaceutical market. The machines have interesting technological solutions ideal for an evolving and demanding production sector. The sterile line is composed by a rotary washing machine WRA24, a depyrogenation Tunnel NLT 120S, a Filling and Stoppering machine Steril 400, an ML670 cap sealing machine and a labeller BL600.

Marchesini Group also offers all necessary solutions for the secondary packaging, from cartoners to pallettizers.

Vial washing machine WRB24-8 by Co.Ri.M.A.- The rotary washing machine, equipped with ultrasonic bath, is completely driven by brushless motors. All devices for the management of washing media such as tanks, pumps, valves, filters and instruments, are installed on a skid. This unit is separated from the machine frame for an easier maintenance. Vials are held by pincers on the neck without any interference for cleaning agents on vial body and mouth. The size change-over is fast and easy to carry out as the only format parts to be replaced are located at machine infeed and outfeed

The depyrogenation Tunnel NLT 120S by Neri.- The tunnel is designed to sterilize and depyrogenate the vials. It is also suitable to compensate the overpressure of the filling room and minimize the air flow between the filling room and the washing room. It is composed of three chambers which are elastically and hermetically connected to each other in order to compensate the thermal expansion. The belt is equipped by fixed flaps on the sides in order to avoid any rubbing of the vials and consequent particles generation. It can be equipped with HEPA filters having a ceramic matrix with the same dilatation rate of filter frame and gasket ones. The air for the drying and the cooling chambers is taken from the washing room and filtered by pre-filters in order to protect the HEPA filters and extend their lifetime.

Steril400 - The Steril400 is a linear continuous motion machine for liquid filling in a sterile environment and complete or partial closure of the container using rubber stoppers. Entirely made of AISI 316L stainless steel or FDA approved materials, the machine consists of three modules: infeed, filling/stoppering and outfeed. They can be installed with different layout configurations according to customer needs. The machine can be equipped with isolator, RABS (Restricted Area Barrier System) and/or with laminar flow cabinet. The balcony structure and the complete separation between the mechanical and the filling/stoppering sections allows the mechanical components to be accessed only from the back side, avoiding all contaminations in the front area, protected by the recirculating laminar flow. The machine design assures a perfect laminar air flow to protect the product during and after filling. The PC-controlled machine with simple, fast size change-over can be installed against a wall, with the mechanical part outside the aseptic area, and can be cleaned with H2O2 steam and common detergents for aseptic environments. Thanks to a perfect vial positive transfer system, there is no vial rubbing or particle release. Filling is carried out by rotary piston pumps, eight in the standard version, or up to ten on request. Each pump, having two parts, can be completely disassembled and therefore perfectly sanitised in an autoclave. Each rotary piston pump can be operated by a brushless motor, for precise and independent adjustment of the filling volume, whilst the stopper turret, loading system and vibrating base have automatic height adjustments. The machine can also be provided with a statistical weight check group, performed by a robotised vial pick and place system.

Steril400 main production features: 400 vials/minute, filling volume up to 30 ml and maximum vial diameter up to 36 mm.

ML670 aluminium cap sealing machine- The ML670 is a rotary cap sealer The ML670 is a rotary aluminium cap sealer ideal for sterile environment, high speed  applications. The capping turret has ten capping chucks, is entirely made of 304 SS and is designed according to GMP regulations. The machine is equipped with brushless servomotors controlled by a PC architecture.

The greatest advantage of the machine is the perfect synchronization between machine and capping chucks speeds, allowing an extremely high quality cap seal and avoiding the creation of any particles.

Both the pressure applied on the top of the alu seal and on the sealing blade can be set-up and constantly controlled through the PC, therefore allowing the highest possible sealing quality and the reject of any vial not falling within the set-up parameters.

Labeller BL600 by Neri. – The BL600 is a new concept, high speed linear labelling machine for applying self-adhesive labels on ampoules, vials and other round containers. It has innovative features specifically designed to meet the most different labelling requirements as well as maximum accessibility and excellent ergonomics.. The machine, which can process up to 600 items per minute, guarantees fail-safe operation, has a cantilever structure with ergonomic arrangement of all units and clearly separated working, mechanical and electrical zones. The adjustable roller conveyor can handle a wide range of sizes; automatic change-over through the HMI can also be provided in order to allow even greater flexibility. As a result, the size change-over is extremely simple and fast and cleaning and maintenance are very easy.