Interpack 2023: Marchesini Group takes stock of its aseptic technologies
In the large area reserved for sterile and injectable drugs, at Interpack 2023 Marchesini Group will unveil for the first time NSY - a no-contact monobloc machine for the high-speed automatic inspection of syringes, with integral denesting and renesting unit - and a syringe filling machine EXTRAFILL-10.
NSY: a brand-new no-contact monobloc machine for the high-speed automatic inspection of syringes
NSY is the outcome of close cooperation between two of the Marchesini Group’s divisions: Corima, a Siena-based company specialized in technologies to guarantee the sterility of the injectables production process, and CMP Phar.ma from Vicenza, which produces pharmaceutical inspection machines.
The monobloc consists of a unit which performs robotised picking of the syringes from tubs/nests and feeds them into the inspection phase in a single row with no contact between syringes or with metal parts. The heart of this solution is inspection itself, which can achieve speeds of up to 36,000 syringes/hour.
This part of the machine is able to contain up to ten inspection stations to inspect every zone of the syringe: flange, stopper, particle detection, filling level, needle shield, defects in the glass walls and integrity inspection using HVLD (High Voltage Leak Detection) technology.
The monobloc features five reject lanes which can be customised to differentiate the rejected syringes and is designed to deliver approved syringes in a single row, without any contact between them or with metal parts.
Last but not least, the machine, which has a robotised unit for renesting the syringes in tubs/nests from the denesting station, can be equipped with a variety of optional accessories, including a camera to inspect for nest completeness and the relative syringe count, or coding of the nest or tub by labelling or inkjet or laser printing.
EXTRAFILL-10: a perfect combination of high speed and flexibility
The syringe filling machine EXTRAFILL-10 - so called because it is equipped by 10 dosing heads - has been conceived to fulfill the highest quality requirements of the pharmaceutical industry. It can process RTU (Ready to Use) vials arranged into nest and tubs having the same sizes of syringe’s nest or into single-piece nested-tray.
EXTRAFILL-10 is capable of running small size syringes up to 600/min (36.000/h). The high speed is necessary for high production volumes, typical of vaccines filling campaigns, but it is important even in case of preservative-free products which must be filled in a short time.
Its design allows an easy integration on the pharma-wall with a balcony style philosophy, which makes perfect the air flow laminarity over the containers. The wall integration makes also possible to perform regular maintenance tasks through the backside with no contamination of the filling room, exactly as required on the cGMP Annex 1. However, the EXTRAFILL-10 can be installed even in the middle of the filling room with no back-side integration on the pharma wall.
Another main feature of the EXTRAFILL-10 is the 100% in process weight control, maintaining the production speed at more than 300/min.
The rubber stopper feeding unit is another important innovation. The vibratory bowl works as a pre-feeder while sorting and buffering is performed by the vibratory linear tracks. Such a system offers two important advantages. The first is surely related to the easy format change over. The second is the feature of automatic rejection of sticky stoppers; twin-stoppers can be rejected without causing any jam on the feeding tracks; they are recirculated into the pre-feeder.
A high level of robotization is installed on the EXTRAFILL 10 filling line: a robot is used for high-speed syringe or vial denesting and loading on the linear transport system; a second robot is installed on the unload area, to avoid glass-to-glass contact.
At level of containment strategy, the machine can be supplied with open RABS, closed RABS or under our isolator of the series ISOL-AIR.