GENiSYS C Automated Filling & Closing System for Vials, Syringes & Cartridges

R&D, Engineering Runs, Small Batch cGMP Filling & Closing

AST’s GENiSYS® C is an advanced, yet compact, filling and closing system for automated processing of nested, custom and ready-to-use vials, syringes and cartridges.  With many features typically found in large scale filling machines, the GENiSYS® C’s compact footprint makes this system ideal for use in small scale filling applications, including: R&D, process development, engineering runs, niche product manufacturing, and even cGMP clinical and small batch commercial manufacturing.

 

Superior Process Flexibility

GENiSYS® C is the ultimate “multi-tool” for small batch aseptic applications.  Its design provides unrivaled flexibility in a compact layout, with an intuitive and simple to operate user interface.  The GENiSYS® C is designed to process nested, ready-to-use and custom vials, syringes and cartridges.  The system can be configured with advanced system features and capabilities, including: peristaltic and rotary piston pumps, integrated in-process weighing (IPC), viable, non-viable and particle monitoring (EM), electronic batch record (EBR) reporting, inert gas purging, and vacuum or vent-tube piston insertion of pre-filled syringes and cartridges.

 

Aseptic Barrier Technologies

The GENiSYS® C is designed for use within a Laminar Airflow Hood (LAF) or Restricted Access Barrier System (RABS), making the system ideal for use in labs and clean rooms with minimal available space.  AST’s meticulous attention to aseptic design, selection of the materials and surfaces has been done to ensure that the system meets cGMP standards for aseptic processing.

  • Laminar Airflow Hood (LAF)
  • Restricted Access Barrier System (RABS)

 

Maximize Product Yield

Eliminating waste is key to successful small batch processing.  Necessary operations such as pump calibration, on-going fill volume checks and residual product hold-up in the fluid path all contribute to wasted product material.  The GENiSYS® C in-process control system allows for 100% fill weight inspection and real-time filling directly on the electronic weigh scale to eliminate improperly filled containers and minimize product hold-up at the end of the batch in order to maximize product yield.  Couple this with ASTView Electronic Batch Record (EBR) system, and you are able to have a complete record of the dispensed product.

 

Advanced System Features:

  • In-Process Control (IPC) that provides real-time fill weight feedback and control - maximizing product yield
  • ASTView is a high-resolution interface that provides intelligent and intuitive control and real-time process monitoring of the system
  • Servo-Driven Motion control system provides accurate and repeatable filling and closing of nested vials, syringes and cartridges
  • Process flexibility that provides multiple dispense and closing options for syringes, vials and cartridges
  • Aseptic Barrier options allow the system to be integrated with a Laminar Airflow Hood (LAF) or RABS technology for aseptic environments
  • Electronic Batch Report (EBR) System records critical process information that can be used to create 21 CFR Part 11 compliant batch reports

 

Applications include:

  • Small to medium batch production of commercial and clinical materials
  • Filling of toxic and cytotoxic materials
  • Filling and assembly of custom devices and containers
  • R&D, pre-clinical and drug process development
  • Engineering runs

Benefits

  • Single integrated system for automated processing of ready-to-use vials, syringes and cartridges
  • Can be configured with multiple pump options including rotary piston for accurate product dosing
  • Automated syringe and cartridge piston placement using vacuum or vent-tube insertion and a variety of stoppering options
  • No glass-on-glass or glass-on-metal contact eliminates common quality challenges
  • Programmable filling needle motion
  • Historical process data accessible with Excel
  • Simple format parts allow for fast and easy change-over between batches
  • Intuitive operator interfaces and controls
  • Weigh cell integration automates pump calibration and fill weight measurement for statistical sampling or 100% In-Process Weight Check with minimal reduction in processing speeds
  • Standard line options available with quick delivery
  • Compact footprint minimizes lab or cleanroom space
  • Capable of inert gas purging during filling
Machine Model: GENiSYS® C10 GENiSYS® C20
Dimensions (LxWxH)

1830mm x 622mm x 1672mm

[60" x 24" x 66"]

Containers:

Pre-sterilized vials, syringes and cartridge

(Note: Tooling for non-standard/custom container formats available)

Vial Sizes: 2mL to 30mL (ISO 2R – 30R)
(Note: Options available for vials greater than 30mL)
Syringe Sizes: 0.5mL to 20mL
Cartridge Sizes:

3mL, 5mL & 20mL

(Note: Options available for sizes not listed)

Production Rate: Up to 10upm Up to 20upm
Dispense Options: Peristaltic & Rotary Piston
Filling Volume: 0.1mL to 250mL
Filling Accuracy Up to ±0.5%
Syringe / Cartridge Stoppering Method: Vacuum & Vent-Tube
Barrier System: Laminar Airflow Hood (LAF)
Electrical Utilities: 110/220VAC – 50/60Hz.
Human-Machine Interface (HMI) ASTView on a 10" color touchscreen
Materials of Construction: Pharmaceutical grade stainless steel, plastics and elastomers
Available Options:
  • In-process fill weight verification (IPC) and automated pump calibration
  • Viable and non-viable environmental monitoring (EM)
  • Pre & post-fill container purging with inert gas
  • Extended Laminar Airflow (LAF) Hood
  • ŸElectronic Batch Report (EBR) system

 *Figures are typical. Actual performance results and technical parameters may vary depending upon application requirements. 

**Subject to change without notice.

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