ASEPTiCell - Aseptic Small / Medium Batch Filling & Closing Machines

 Advanced cGMP Aseptic Processing – Small or Medium Batch Commercial

Today’s injectable drug products require flexible fill/finish systems that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

AST’s ASEPTiCell® 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.

By integrating standard process modules into an advanced robotic fill/finish system, the ASEPTiCell® provides unrivaled flexibility for cGMP aseptic production of Ready-To-Use Vials, Syringes and Cartridges, making the ASEPTiCell® the ideal fill/finish system for small to medium batch size commercial drug product applications.

The ASEPTiCell® 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.

 

Small & Medium Batch Capabilities

The ASEPTiCell® is easily configured to process all ready-to-use, nested, vial, syringe and cartridge formats for small and medium commercial batches.  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
  • Lyo or Lyophilizer Integration

 

Flexible & Modular System Design

In order to meet a wide range of customer and application needs, the ASEPTiCell® 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:

  • Semi-Automatic (SABO) or Automatic (ABO) Bag Opening
  • Automatic Tub Opening (ATO)
  • Automatic Filling & Closing (FCM)
  • Lyo Prep (LPM)
  • Vial Sealing (VSM)

 

Aseptic Barrier Technologies

ASEPTiCell® 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 condition during production.  With isolator integrated systems, the ASEPTiCell® 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)

 

Applications:

  • Small to medium batch production of commercial and clinical materials
  • Biologics, proteins and potent products
  • Filling of toxic and cytotoxic materials
  • Multi-product aseptic filling facilities
  • Pilot scale cGMP manufacturing

Benefits

  • Single integrated system for automated aseptic processing of ready-to-use vials, syringes and cartridges, without the need for docking modules or trollies
  • System can be integrated with multiple aseptic barrier options
  • Can be configured with multiple pump options including rotary piston for accurate product dosing
  • Automated syringe and cartridge piston placement using vacuum or vent-tube insertion and a variety of stoppering options
  • No glass-on-glass or glass-on-metal contact eliminates common quality challenges
  • Advanced features fully automate the production process to provide “hands off” operation
  • Historical process data accessible with Excel
  • Robotic flexibility and simple format parts allow for fast and easy change-over between batches in as little as 30 minutes
  • Intuitive operator interfaces and controls
  • Programmable compression force and crimping speed allows for automatic sealing head adjustment
  • Weigh cell integration automates pump calibration and fill weight measurement for statistical sampling or 100% In-Process Weight Check with minimal reduction in processing speeds
  • Compact footprint minimizes lab or cleanroom space
  • Capable of inert gas purging during filling
Machine Model: ASEPTiCell r50/i50 ASEPTiCell r100/i100
Approximate System Dimensions (LxWxH): 5500mm x 1800mm x approx. 3000mm
[216" x 110" x 118"]
6500mm x 1800mm x approx. 3000mm
[256" x 110" x 118"]
Containers: Pre-sterilized vials, syringes and cartridges
Vial Sizes: 2mL to 30mL (ISO 2R – 30R)
Syringe Sizes: 0.5mL to 20mL
Cartridge Sizes: 3mL, 5mL & 20mL
Production Rate: Up to 50upm Up to 100upm
Dispense Options: Peristaltic & Rotary Piston
Filling Volume: 0.1mL to 250mL
Filling Accuracy: Up to ±0.5%
Syringe / Cartridge Closing Method: Vacuum & Vent-Tube
Barrier System: Restricted Access Barrier System (RABS) or Isolator
Electrical Utilities: 230/480VAC - 50/60Hz.
Clean Air Utilities: Clean dry air 7 bar, 0.5L/min free air
Materials of Construction: Pharmaceutical grade stainless steel, plastics and elastomers
Human-Machine Interface (HMI) ASTView on a 21" color touchscreen
Module Options:
  • ŸBag Opening: Semi-Automatic Bag Opening (SABO) or Automatic Bag Opening (ABO)
  • Tub Opening: Manual Tub Opening (MTO) or Automatic Tub Opening (ATO)
  • Lyophilization Prep / De-Nesting Module (LPM)
  • Vial Sealing Module (VSM)
Available Options:
  • ŸIn-process fill weight verification (IPC) and automated pump calibration
  • Viable and non-viable environmental monitoring (EM)
  • Electronic Batch Report (EBR) system
  • Pre & post-fill container purging with inert gas

 *Figures are typical. Actual performance results and technical parameters may vary depending upon application requirements. 

**Subject to change without notice.

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