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The ASEPTiCell: The Full Power of Robotics for Aseptic Fill-Finish Production
The ASEPTiCell® is where the full power of AST’s automated and robotic solutions meets precision modular engineering for the commercial production of medium-batch liquid pharmaceuticals. Featuring fully automated filling, closing, and sealing of RTU containers from start to finish, this highly intuitive, flexible fill-finish system was the industry’s first aseptic multi-format filling line capable of processing ready-to-use nested vials, cartridges, and syringes on a single line. The latest-generation ASEPTiCell builds on that initial innovation, offering industry-leading multi-modal flexibility, efficient recipe-driven production, and fewer change parts for minimal format changeover time and optimal machine uptime.
In the Know
Capabilities
- Tested, standardized modules configurable for fully automated commercial processing needs
- cGMP technology across all modules
- Universal RTU container processing capabilities
- Scalable solutions for easy validation and efficient technology transfer
- Product stewardship measures for quality control and high-value products
- Full ramp-up support, including qualification services and full documentation packages
- Responsive, 24/7 aftermarket support throughout the life of your equipment
- Isolator or RABS configuration
- Compact, Integrated configuration for a smaller operational footprint
- Processes up to 100 units per minute
- Configurable, recipe-driven production
- Toolless change parts
- Processing tools and robotics never drop below working height
- Processes vials, syringes, and cartridges on the same line with minimal changeover time between formats
- EM suite design, including optional automated plate handling
- No glass-on-glass or glass-on-metal contact eliminates common quality challenges
- Peristaltic and rotary piston pump options
- ASTView, a centralized HMI for intuitive operation and data retention, and an optional EBR system for 21 CFR Part 11 Compliance
- For syringes and cartridges, Piston insertion for options for the full scope of drug product properties and sensitivities
The ASEPTiCell is the ideal solution for parenteral drug manufacturers looking for a higher throughput and larger batch-size processing. The system features a throughput of one hundred units per minute and can process batch sizes of 30,000 units or higher. For vial processing, the latest generation system comes with AST’s new VSM-100 for high-speed vial capping. Additionally, the system is available with 100 percent IPC functionality with no compromise to machine output.
When combined with the new Atmos™ isolator, The ASEPTiCell is a robust fill-finish system with industry-leading cycle times and designed as a comprehensive, user-friendly turnkey solution.
The ASEPTiCell leverages the latest in robotics and automation for the flexible processing of RTU Containers. The advantages of end end-to-end robotics include:
- Built for ISO 5 – Grade A operations
- Non-absorptive & microbially resistant
- FDA compliant
- VPHP compatible
- Minimal human interventions
- Intuitive design, made for round-the-clock operation
- Gentle container handling
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Interactive Diagram of ASEPTiCell | Click a Hotspot
Automatic Bag Opening with hygienic trash removal and no-touch transfer into Grade A space
Robotic tub handling with seal removal and staging with minimal particle generation
ASTView, a centralized HMI fully integrated for fill-finish and isolator operation and data retention
Robotic, recipe-driven filling and closing of containers with in-line quality controls, product recovery and reject handling
Annex 1 Compliant High speed vial capping
Atmos™ Isolator Technology for Grade A air handling and critical zone processing
The Next Tier of No-Touch Technology
Lead time and machine changeover requirements are crucial to the time-to-market equation for pharmaceutical manufacturers. The built-in philosophy at AST approaches fill-line configurations in an adaptable way that prioritizes customer’s specifications. Like grabbing the right tools from a toolbox, AST’s modular approach enables our team to capture the majority of requirements with our existing modular solutions, which allows very rapid configuration, delivery, validation, and launch of an operation.
The available modules on the ASEPTiCell are:
- ABO – Automatic Bag Opening
- ATO – Automatic Tub Opening
- FCM – Fill / Close Module
- LPM/LTM – The Lyo Processing and transfer module
- VSM – Vial Sealing Module
(also available in a linear configuration) - OFM – Outfeed module
You’ve seen the ASEPTiCell® in action…
Now discover how this solution can work for your application.
Meeting Industry Needs | Applications
AST has led the flexible aseptic manufacturing movement since the design and launch of our first ASEPTiCell, which was the industry’s first multi-format system designed to process ready-to-use nested vials, cartridges and syringes. Now an industry standard, multi-modal pharmaceutical manufacturing stakeholders are looking for ways to grow pipeline agility through proven cGMP technology. AST’s ASEPTiCell offers fill-finish processing for the full range of commercial and custom RTU formats and product applications.
AST’s robotics are designed to execute critical processes with precision and repeatability across the fill-finish line. Simplified, well-designed movements are a way to ensure that robotic handling adheres to proper aseptic technique, which is especially crucial in critical zones and for cGMP compliance, including alignment with the new Annex 1. Robotic processing in the ASEPTiCell minimizes air disturbance over exposed product, and unidirectional airflow is always maintained.
When compared to other similar solutions, the ASEPTiCell offers a more compact, flexible solution with equal or greater optimization for throughput and quality. Designed as a 100 percent integrated solution, the ASEPTiCell leverages the latest in hygienic robotic technology in a powerful turnkey system that features end-to-end flexibility, product stewardship, and programmable, recipe-driven operations. Important operational features include hands-free de-packaging and container handling, automated visual inspections, in-process weight checks, and fast format changeover of robotic tooling for processing vials, cartridges, and syringes on the same line.
The continued growth of highly targeted biologics, like cell and gene treatments, requires commercial production at an agile pace with new strategies in place for quality and yield. The demand represents good news: More and more people are getting life-improving and life-saving results from these innovative treatments.
The heart of AST’s ASEPTiCell is the flexible, robotic FCM, designed for commercial-level filling and closing of liquid pharmaceuticals. It offers in-nest processing for tubs and custom nest configurations for trayed formats. The FCM leverages simultaneous filling and nest handling with no wasted motion while maintaining First Air, making it an ideal solution for the development and production of the latest biopharmaceuticals.
Use Cases
FAQs
Does this system process in-nest?
The system is designed for the in-nest processing of up to 100 units per minute or up to two tubs at a time, depending on the configuration of the nest. Processing has been designed to maximize laminar airflow for critical zone operations and maintain First Air throughout filling and closing of the container.
What are the options for closing or finishing containers?
The ASEPTiCell can be configured for all universal RTU closing requirements for vials, syringes, and cartridges, including press-fit cap applications. For higher throughput vial sealing, this system features the VSM-100, a rotary-spinning disk vial sealer that processes 100 vials per minute.
With a higher throughput, does this system offer IPC?
Yes, the ASEPTiCell offers both statistical IPC and Augmented IPC for 100 percent in-process weight checks, which executes weight checks for all containers while remaining in a statistical sample mode for minimal impact to machine processing speed.
What Commissioning, Qualification, and Validation (CQV) services does AST offer?
AST offers as-needed or complete CQV training and services through AST Academy, depending on the needs of the project. This includes the full-service AST Launch for accelerated operational startup.
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