GENiSYS® C R&D, Engineering Runs, Small Batch CGMP Filling & Closing
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.
Capabilities
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), 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
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), 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
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
- 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
