The solutions supplied by the Marchesini Group for injectables have been boosted by the new model of STERY-LA for filling and stoppering vials in an aseptic environment. The new unit features the traditional Marchesini vertical balcony design, which perfectly separates the filling process and the mechanical components, located at the back of the machine. The laminar flow has reached the highest possible level of efficiency to ensure product sterility, the company said.
The balcony technology also makes it possible to discharge or recover the air from the laminar air flow through the bottom, ensuring a uniform flow of air without dead zones or turbulence. It also makes machine cleaning much easier.
STERY-LA also integrates a range of solutions to control and ensure the quality features of the end product, such as the weight control system of 100% of batched product.
Combined with the batching systems (peristaltic pumps and rotary piston pumps) installed on the machine, it guarantees batching precision, minimises dead product volumes and makes it possible to manage the machine in every configuration.
By exploiting this In Process Control (IPC) system throughout the production process, each vial is weighed before and after filling; any “out-of-target” vials will be individually rejected. If the target volume is systematically displaced, the filling volume dispensed by each single dosing pump can be individually adjusted.
Marchesini said special attention has been paid to managing the rubber stoppers. An especially designed system has been installed to maximise this function, even when the stoppers stick. The stopper pre-infeed and infeed systems have been integrated into the machine in order to ensure the highest possible standards of accessibility and ergonomics currently available.
The company has also developed the “ISOL-AIR” isolator, which can be supplied together with the air conditioning system (HVAC), sized to cut the decontamination cycle times, with hydrogen peroxide vapours.
STERY-LA fully meets all the provisions enforced by regulatory authorities for injectables and, especially in the case of isolated filling lines for potent drugs, cuts water consumptions during the Wash-In-Place (WIP) cycle and halves drying and decontamination times compared with conventional table-top machines.
The aseptic packaging solution is complete with CAPSY-LC, an alu-capping machine for SVP (Small Volume Parenteral) solutions processed in an aseptic environment. It has been designed so that containment systems such as cRABS or isolators can be easily installed.
The balcony design of CAPSY-LC ensures:
- excellent laminar air flow: the air can be discharged or recovered at the bottom of the machine, thus guaranteeing air flow without dead zones or turbulence
- perfect segregation of the operational area theoretically contaminated by potent drugs. The zone where mechanical components are installed is air-tight and separated from the processing area.
Fully integrated system
Once filled by STERY-LA, the vial containing the Liquid Product is sent to CAPSY-LC for immediate capping. As an option, for filling lines of liquid and Lyo drugs, half stoppered vials can by-pass the capping station to be fed to the Automatic Loading System of a Freeze Dryer. Once lyophilized, full stoppered vials return from the Freeze Dryer and run along the internal by-pass conveyor in the opposite direction to be fed to the capping station.
This system represents a very compact 3-way vial diverting system fully integrated into the same isolator of the CAPSY-LC machine.
Machine compactness is an extremely important factor to reduce the running costs of an isolated line. The cap pre-feeder fills the hopper directly from sterile Beta-bags on the operator side without any other steps in-between.
In the capping phase, both the compression force on the cap (via a proportional regulator) and the spinning speed of the cap against the blade (via brushless motor) are controlled so that the process is perfectly repeatable.
The result is a compact and efficient machine designed to be easily installed against the wall, to guarantee safe use for operators and to be integrated into line with the filler, loaders, buffers and loading and unloading units for freeze-dried products.
