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 allow 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 conditions 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)
- 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
- 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. 3200mm
[216" x 110" x 125"]
|6500mm x 1800mm x approx. 3200mm
[256" x 110" x 125"]
|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|
380/480VAC - 50/60Hz.
220/110VAC - 50/60Hz.
|Clean Air Utilities:||Clean dry air 6 bar, 56L/min free air|
|Materials of Construction:||Pharmaceutical grade stainless steel, plastics and elastomers|
|Human-Machine Interface (HMI)||ASTView on a 21" color touchscreen|
*Figures are typical. Actual performance results and technical parameters may vary depending upon application requirements.
**Subject to change without notice.