Z-810
This advanced modular technology is designed to mitigate any potential microbiological contamination, while simultaneously offering exceptional flexibility, swift changeover, and superior quality.
Our technology stands at the cutting edge of Annex 1 compliant design, offering pharmaceutical companies a suite of top-tier features. These features are designed with a primary focus on patient safety and emphasize compliance, efficiency, precision, and reliability.
The platform provides excellent accessibility, facilitating effortless operation and cleaning. Depending on the specific application, the platform can be equipped with Statistical In-Process-Control (IPC) or 100% IPC to ensure optimal performance.
Accompanied by a comprehensive set of (GMP) documentation, the Z-810 platform guarantees adherence to regulatory standards. It is capable of handling an impressive output of up to 165 products per minute, demonstrating its high efficiency and productivity.
Fully featured fill-finish
All common ready-to-use syringes, vials and cartridges in a tub/nest configuration on one platform. The filling process begins with debagging and the entry of the sterile RTU into infeed station. From here, a conveyor belt transports the tub to a dedicated automatic station where the Tyvek and slipsheet are carefully removed using a combination of heat and vacuum. This prepares the tub for the nest removal at the delivery station.
After removal of the nest from the tub, it is placed into a format part controlled by a Stäubli 6-axis robot, that positions the nest beneath the dosing station. Aseptic filling of the liquid or gel into the container takes place and stoppers are methodically inserted in rows under vacuum to assure a bubble free product.
Once all containers are securely closed, the process advances to the next station. Syringes and cartridges are generally returned to the tub which exits the machine onto an outfeed conveyor. In Vial filling applications an additional module is utilized for crimping that is separated from the filling zone in order to comply with Annex 1. A sensor-based quality control system meticulously checks each vial to ensure the crimp-on cap is fitted correctly, removing any defective products. The accurately filled and sealed vials are then arranged in rows, ready for tray loading or secondary packaging.
Future proof flexibility
The modular design platform, allows for upgrade to different nested container types in future, providing a technology that can adapt to your future business requirements while maintaining a robust compliant process.
Details
Precision Handling: Robot integration for precise handling with maximum performance. Format parts that support the container precisely during the filling and stoppering processes. Annex 1 compliant design.
Virtual cockpit (HMI): Our HMI system gives you the ability to control your production using recipe management, obtain batch report, make line clearance, and various service topics. cGMP documentation. Audit trail.
Aseptic Filling in an Isolator or under LAF, RABS: Aseptic transfer of materials and media. Filling, stoppering, and crimping of products according to Annex 1 guideline. Particle counters. Microbial Air samplers. Connection to LYO technology.
Workflow
Specifications
Whether for sealing tests in the laboratory or industrial mass production: we’ll help you find the right machine for every application, or create a solution specifically for your business.