GENiSYS® C Multi-Format Filling and Closing Machine

Source: AST
GENiSYS C rendering

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 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.

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 dispenses 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