Small-Batch Aseptic Filling Equipment (GENiSYS i20)

Small Batch Aseptic Processing Machine (GENiSYS i20) 

Just because batches are small doesn’t mean you have to compromise on productivity or quality. AST’s GENiSYS i20 uses isolator technology for aseptic processing making it so that you don’t have to compromise on either. GENiSYS i20 combines its proven GENiSYS system design with isolator technology to provide the most flexible and compact isolated aseptic filling system for processing ready-to-fill vials, syringes, and cartridges.

Design Advantage:

  • The GENiSYS i20’s innovative design delivers this wide-range of container processing capabilities without the need of additional machine modules or trolleys that dock to the isolator; saving you money and valuable cleanroom space.

 

Applications include:

  • Clinical materials manufacturing
  • R&D and drug process development
  • Stability studies
  • Small batch commercial manufacturing
  • Compounding pharmacies

Pharmaceutical Isolators 

We have designed our small batch aseptic processing machines to be easily integrated with pharmaceutical isolators. Isolators are designed to seamlessly enclose our small batch aseptic filling and closing (GENiSYSi20) systems so that operators can intervene in the aseptic process in a safe and secure manner cutting down on production costs. At AST-inc our patented aseptic filling and closing machines (GENiSYSi20) are made specifically for aseptic product testing on a clinical or smaller scale. The increased popularity of filling line isolators for potent product handling offers the user protection and safety they can trust. Pharmaceutical isolators will also eliminate the need for PPE and decrease the cost of medical attention for operators.

Benefits

  • Flexible small batch production
  • Highest level of sterility assurance
  • Containment of cytotoxic and potent materials
  • Automated processing of ready-to-fill syringes, vials, and cartridges
  • Gentle robotic handling of each container
  • Fast and easy change-over between batches
  • Automated fill weight measurement and control
  • Multiple syringe and cartridge stoppering options

GENiSYS i20 Design Capabilities

Aseptic Processing Flexibility

  • The GENiSYS i20 is a highly flexible filling system for filling and stoppering pre-sterilized syringes, vials and cartridges on a single compact machine.  The system is integrated with and aseptic isolator and offers advanced features to ensure that each container is handled with care and to consistently produce the highest quality sterile products.
  • GENiSYS i20 innovative design provides all the flexibility necessary to process ready-to-fill vials, syringes and cartridges without the need of additional trolley’s or modules to dock to the isolator.  By quickly changing machine format parts the system is ready to process another container type.
  • GENiSYS i20 provides flexible stoppering options available for plugging and closing vials, syringes and cartridges.  The system allows for syringe and cartridges pistons to be inserted using vacuum or vent-tube options, and vials can be fully or partially stoppered.  By offering conventional stoppering processes at a bench-scale GENiSYS i20 makes tech transfer and scale-up simple and straight forward.

Aseptic Process Integration

  • GENiSYS i20 integrates with a four-glove aseptic isolator chamber with material infeed and exit air locks.  The isolator chamber interior, material air locks, and equipment are compatible with Hydrogen Peroxide (H2O2) bio-decontamination.  The system uses an innovative bio-decontamination system, Esco Bio-Vap™, that minimizes the overall bio-decontamination cycle time and eliminates common sterilant distribution challenges encountered with traditional vaporized H2O2 systems.
  • GENiSYS i20 can be integrated with peristaltic or rotary piston pumps for accurate and gentle product dosing. The design of the dosing system was carefully considered to minimize product waste and is the only compact multi-format filling system available with an integrated In-Process Control (IPC) system that automatically weighs the volume of the dosed container. The IPC system can perform statistical to 100% weighing of each container filled. The pumps integrated with the IPC system minimize product waste common to the beginning and end of batch operations.

 

 

GENiSYS™ is a compact aseptic filling machine specifically designed for small batch manufacturing of parenteral products. It is capable of filling and closing ready to use vials, syringes and cartridges on a compact, capable and highly flexible platform. It is the perfect solution for product development, clinical trials or small scale commercial manufacturing.

Technical Information

Machine Model:

GENiSYS c10/20

GENiSYS r10/20

GENiSYS i10/i20

Dimensions (LxWxH)

1830mm x 622mm x 1672mm

[60" x 24" x 66"] 

1955mm x 860mm x 2405mm

[77" x 34" x 95"]

3320mm x 927mm x approx 2100mm

[130" x 36" x 82"]

Containers:

Pre-sterilized vials, syringes and cartridges

Vial Sizes:

2mL to 30mL (ISO 2R – 30R)

Syringe Sizes:

0.5mL to 20mL

Cartridge Sizes:

3mL

Production Rate:

Up to 25 containers per minute

Dispense Options:

Peristaltic & Rotary Piston

Filling Volume:

0.1mL to 250mL

Filling Accuracy:

Up to ±0.5%

Electrical Utilities:

110/220VAC – 50/60Hz.

110/220VAC – 50/60Hz.

230/480VAC - 50/60Hz.

Syringe / Cartridge Stoppering Method:

Vacuum & Vent-Tube (Mechanical)

Barrier System:

Laminar Airflow (LAF) Hood

Restricted Access Barrier System (RABS)

Isolator

Materials of Construction:

Pharmaceutical grade stainless steel & plastics

Available Options:

  • In-process fill weight verification (IPC)
  • Viable and non-viable environmental monitoring
  • Electronic Batch Reporting (EBR)
  • Pre & post-fill container purging with inert gas

*Figures are typical.  Actual performance results vary depending upon application requirements. 

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