VDW Verein Deutscher Werkzeugmaschinenfabriken e.V.

Marchesini group is glad to present the Iso-technique line for oncological drugs arranged for both liquid and lyophilized alcohol-based products sold to Chemifarma. The line can process from 6.000 to 24.000 pieces in just one hour. It consists of a vial rotary loading table where the small containers are loaded, a rotary washer WR 16 that washes the inside of the containers, the depyrogenation tunnel DEPYR 901 produced by NERI, the vial filling machine for aseptic products, STERY LC, the freeze-drier LYOMEGA 100ST made by Telstar, the alu-seal capping machine CAPSY and the rotary washing machine that decontaminates the outside of the containers, WRE.

HOW THE ISO-TECHNIQUE LINE FOR ONCOLOGICAL PRODUCTS WORKS?

Step 1
The sterilization process starts inside the rotary washing machine WR16, which decontaminates up to 400 pieces in one minute and guarantees 3-log reduction of contaminants. The result is a perfectly clean container, both inside and out, before the next step takes place: product depyrogenation.

Step 2
After washing, the containers are fed through the DEPYR 901 tunnel which, thanks to its 3-log reduction of contaminants, eliminates any feasible external substances, for example bacterial toxins that are capable of raising body temperature. This tunnel is equipped with a dynamic balancing and dry-heat sterilization system of the cooling zone, with split circuit. It works with a counter pressure of 75 Pascal, as requested by relevant FDA and EMEA standards. The pressures of each zone can be adjusted separately to generate the perfect gradient for the process in progress.

Step 3
Once the containers have been fed onto an accumulation table, with external drive separated from the tunnel by a shutter/bridge, they move into the linear and continuous-motion filling machine STERY LC, which works with positive conveyance of the individual container.

During the filling phase, the vials are perfectly exposed to the laminar air flow, centred and never come into contact with the guides or with any other mechanical part, thus preserving their sterile conditions. The vials are filled via continuous-motion by peristaltic or volumetric pumps (which can both be used on the same machine) by means of a walking beam driven by another brushless motor, whose different movement phases can be programmed: this means that the up and down ramps and the speeds can be programmed according to the product, to the vials and to other factors that may affect the filling process, thus offering maximum line customization.

Step 4 e 5
After the filling and closing phase, the containers are fed through the freeze-drier model TELSTAR LYOMEGA 100ST. This unit has an automatic push-in/push-out loading system. From the freeze-drier, which works at a minimum temperature of -65°C with the possibility to load with pre-cooled plates at - 45°C, the containers reach the alu-seal capping machine CAPSY LC. To improve product protection, the alu-cap infeed zone is situated downstream from the capping head, therefore in a zone where the vial is already considered to be sealed.

The new alu-cap pre-feeder allows the hopper to be filled directly from sterile bags on the operator’s side without any other in-between phases. Moreover, during the capping process, the alu-cap compression force is controlled (by means of a proportional regulator), as well as the compression position and the rolling speed of the alu-cap on the blade (by means of a brushless motor) in order to ensure perfect process repeatability.

Both Stery and Capsy guarantee perfect and safe access to all the critical zones, also using gloves, simpler spare-part management and maintenance and are pre-arranged to be able to integrate cRABS or isolators. Thanks to their balcony design – which offers excellent exposure to the vertical laminar air flow and consequently cuts washing, drying and decontamination times by 50% compared with conventional machines – these machines have reached the highest degree of efficiency of the laminar air flow to protect the area in which the product is exposed and perfect segregation of the area with controlled contamination from that in which the mechanical components are installed. The resulting solution is fully compliant with the provisions of the regulating authorities in terms of injectables.

To conclude, the container reaches the rotary washing machine WRE where the outside of the containers is decontaminated and subsequently dried. By protecting the capsule, the machine decontaminates the external surfaces of the containers and guarantees at least 3-log reduction of contaminants. The perfectly decontaminated container is then sent to the traying machine where the packaging process ends.