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GENiSYS® C

GENiSYS®  C

GENiSYS® C

Product catalog summary
Overview: The GENiSYS C is a compact and flexible small batch filling system designed for aseptic production. It offers a user-friendly interface and can handle nested ready-to-use or custom vials, syringes, and cartridges. The system is ideal for labs and cleanrooms with limited space.
Key Features:
  • In-Process Control (IPC): Provides real-time weight feedback to maximize product yield.
  • Environmental Monitoring (EM): Monitors viable, non-viable, and particle levels.
  • Electronic Batch Records (EBR): Records critical process information for 21 CFR Part 11 compliant reports.
  • Pump Integration: Options include peristaltic, rotary piston, and time pressure filling.
  • Barrier System Integration: Protects products and operators during the filling process.
Integration and Compatibility: The system can be integrated with various barrier systems such as Laminar Airflow (LAF) hoods, Restricted Access Barrier Systems (RABS), and aseptic isolators. It is suitable for R&D, process development, engineering runs, niche product manufacturing, cGMP clinical trials, and small batch commercial manufacturing.
GENiSYS VSM: The GENiSYS VSM complements the GENiSYS C by automating vial sealing with crimp caps. It accommodates various vial sizes and ensures high-quality seals with minimal particle generation.
Technical Specifications:
  • Production Rate: C10 model up to 10 units per minute (upm), C20 model up to 20 upm.
  • Materials: Pharmaceutical grade stainless steel, plastics, and elastomers.
  • Operator Interface: ASTView on a 10” color touchscreen.
Additional Features: The system supports pre-sterilized containers, in-process fill weight verification, automated dynamic pump calibration, and integrated barrier systems. It also offers pre- and post-fill container gas purge options.
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Catalog excerpts

GENiSYS®  C-1

The GENiSYS C provides unrivaled flexibility in a compact layout for small batch aseptic production. With an intuitive user interface, and the ability to process nested ready-to-use or custom vials, syringes and cartridges, the system can be configured to your process requirements. Advanced features include: • n-Process Control (IPC) for real-time weight feedback and I product yield maximization • nvironmental Monitoring (EM) for viable, non-viable, and E particle monitoring • lectronic Batch Records (EBR) to record critical process E information that can be used to create 21 CFR Part 11 compliant batch reports • ump Integration options include peristaltic, rotary piston, and P time pressure filling • arrier System Integration to protect your product and B operators during the filling process GENiSYS C is an advanced yet compact, flexible small batch filling

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GENiSYS®  C-2

GENiSYS C and VSM with extended multi-pressure zone Laminar Airflow hood The GENiSYS VSM pairs seamlessly with the GENiSYS C to automate vial sealing with crimp caps after filling The GENiSYS C is ideal for use in labs and cleanrooms with minimal available space. The system can be fully integrated with a range of barrier systems, including: and stoppering. The VSM can accommodate a wide range of vial sizes, and allows users to set, monitor and record critical recipe parameters. With minimal particle generation during sealing and the ability to provide consistent, high-quality seals, the GENiSYS...

 Open the catalog to page 2

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