GENiSYS® C R&D, Engineering Runs, Small Batch cGMP Filling & Closing

Automated Filling & Closing System for Vials, Syringes & Cartridges

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.

Automated Filling System

Trusted Partner for Maximum Product Yield

Maximize Product Yield

Eliminating waste is the 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.

Capabilities

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.

The GENiSYS C is designed for use within a Laminar Airflow Hood (LAF), Restricted Access Barrier Systems (RABS), and aseptic isolators, 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)
  • Barrier Isolator Systems
  • 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 dispenses and closing options for syringes, vials, and cartridges
  • Aseptic Barrier options allow the system to be integrated with a Laminar Airflow Hood (LAF), RABS or isolator 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
  • 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

  • Automated processing of ready-to-fill vials, syringes and cartridges
  • Up to 20 containers per minute
  • Fast and easy change-over with tool-less change parts
  • High accuracy product dosing
  • Optional fully integrated in-process weight check system
  • Multiple syringe and cartridge stoppering options
  • Viable & non-viable environmental monitoring
  • LAF, RABS or Isolator Configuration
  • High-resolution color touchscreen interface
  • Optional Electronic Batch Reporting (EBR) System
  • 21 CFR Part 11 compliant
  • IQ/OQ and GAMP documentation available

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Technical Information

Machine ModelGENiSYS® C10 GENiSYS® C20
System Dimensions
(LxWxH)
1800mm x 625mm x 1725mm
[71" x 25" x 68"]
ContainersPre-sterilized vials, syringes, and cartridges
(Note: Tooling for non-standard/custom container formats available)
Vial Sizes2mL to 50mL (ISO 2R – 50R)
Syringe Sizes0.5mL to 50mL
Cartridge Sizes1mL to 20mL
(Note: Options available for sizes not listed)
Production RateUp to 10upm Up to 20upm
Dispense OptionsPeristaltic & Rotary Piston
Filling AccuracyUp to ±0.5% (varies with fill volume)
Vial Closing MethodsSerum or Lyo stopper options
Vial Sealing Methods
Press-fit capping; crimping available with optional Vial Sealing Module
Syringe / Cartridge Closing MethodVacuum, Vent-Tube and Vent/Vac Combo
Barrier SystemLaminar Airflow Hood (LAF)
Materials of ConstructionPharmaceutical grade stainless steel, plastics, and elastomers
Human-Machine Interface (HMI)ASTView on a 10" color touchscreen
Available OptionsIn-process fill weight verification (IPC) and automated dynamic pump calibration
Viable and non-viable environmental monitoring (EM)
Electronic Batch Report (EBR) system
Pre & post-fill container purging with inert gas
Extended Laminar Airflow (LAF) Hood

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