GENiSYS® R Automated cGMP Aseptic Small Batch Processing

Aseptic Small Batch Filling & Closing Machine

AST’s GENiSYS® R has a unique blend of automated capabilities to ensure your sterile products, whether clinical or commercial, are processed in strict accordance with cGMP requirements.  The system has the flexibility to adapt to your process requirements and container options alike, and its ability to process all ready-to-fill vial, syringe, and cartridge formats allows you to bring drug products to market cost-effectively.

Aseptic Filling Machine

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GENiSYS® R Automated cGMP Aseptic Small Batch Processing – Clinical and Small-Batch Commercial

GENiSYS R can be configured with advanced system features and capabilities to tailor the equipment for each unique application.  The system meets the highest standards for aseptic processing by providing features such as environmental monitoring, multiple product dispense system options, in-process fill weight control, and electronic batch record reporting.

Capabilities

The GENiSYS R is easily configured to process all ready-to-use, nested, vial, syringe and cartridge formats for clinical and small-batch commercial applications. The use of highly reliable robotics enables a complete system changeover in as little as thirty minutes. The system can include automated lyo loading and unloading.

  • Vial Filling, Closing, and Sealing
  • Syringe Filling and Closing
  • Cartridge Filling and Closing
  • Lyophilizer Integration

In order to meet a wide range of customer and application needs, the GENiSYS R has a modular design that provides our customers a system that is tailored to their application requirements without the cost and risk associated with customization. Available modules include:

  • Manual (MBO) or Semi-Automatic Bag Opening (SABO)
  • Manual Tub Opening (MTO)
  • Automatic Tub Opening (ATO)
  • Automatic Filling & Closing (FCM)
  • Lyo Prep (LPM)
  • Vial Sealing (VSM)
  • In-Process Control (IPC) that provides real-time fill weight feedback and control – maximizing product yield
  • ASTView a high-resolution interface that provides intelligent and intuitive control and real-time process monitoring of the system
  • Robotic processing provides clean, reliable and flexible filling and closing of Ready-To-Use, nested, pre-sterilized 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 either Isolator or RABS technology to ensure an aseptic environment
  • 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
  • Biologics, proteins and potent products
  • Multi-product aseptic filling facilities
  • Pilot-scale cGMP manufacturing

Benefits

Aseptic Barrier Technologies

GENiSYS R is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the GENiSYS R is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.

  • Restricted Access Barrier System (RABS)
  • Isolator – with in-situ bio-decontamination using hydrogen peroxide (VHP)

Maximize Product Yield

Eliminating waste is the key to successful small-batch processing. Necessary operations such as pump calibration, in-process fill weight checks and residual product hold-up in the fluid path all contribute to product rejects. The GENiSYS R’s in-process control system allows for 100% fill weight inspection with minimal reduction in processing speeds to minimize or even eliminate improperly filled containers and minimize product hold-up at the end of the batch – resulting in maximize product yield. In addition, the ASTView Electronic Batch Record (EBR) system provides a complete record of the dispensed material.

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Technical Information

Machine ModelGENiSYS® R20
Standard System Dimensions
(LxWxH)
(SABO-MTO-FCM-VSM)		4225mm x 1400mm x 2405mm
[166" x 55" x 95"]
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
Production RateUp to 20upm
Dispense OptionsPeristaltic & Rotary Piston
Filling AccuracyUp to ±0.5%
Vial Closing MethodsSerum or Lyo stopper options
Vial Sealing MethodsCrimp or Press-fit capping options
Syringe / Cartridge Closing MethodVacuum, Vent-Tube and Vent/Vac Combo
Barrier SystemRestricted Access Barrier System (RABS) or Isolator
Materials of ConstructionPharmaceutical grade stainless steel, plastics, and elastomers
Human-Machine Interface (HMI)ASTView on a 21" color touchscreen
Module OptionsManual Bag Opening (MBO)
Semi-Automatic Bag Opening (SABO)
Automatic Bag Opening (ABO)
Manual Tub Opening (MTO)
Automatic Tub Opening (ATO)
Lyophilization Prep / De-Nesting Module (LPM)
Vial Sealing Module (VSM)
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

Literature

↧ AST Brochure