Flexible Aseptic Fill-Finish Systems for Vials, Syringes & Cartridges

The current and future wave of pharmaceutical and biotechnology products is making historical aseptic manufacturing methodologies inadequate and antiquated.  Traditional production processes used for high volume drug products are stressed to efficiently meet the production requirements of targeted medicines that dominate today’s clinical pipelines.  To address the production and quality requirements these products demand, traditional production processes must be rethought and redeveloped.  Recognizing these trends, AST has developed advanced automated aseptic filling machines dedicated to providing flexible and efficient production of sterile injectables in vials, syringes, and cartridges.

 

Advanced Aseptic Fill-Finish Solutions: ASEPTiCell® & GENiSYS®

AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine.  These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products. 

 

ASEPTiCell® Robotic Production Fill-Finish System

ASEPTiCell® is a robotic filling and closing system designed for commercial and clinical drug products.  The system is an adaptive platform capable of filling and closing ready-to-use vials, syringes, and cartridges on a single integrated platform.  The ASEPTiCell uses standard modules that can be easily configured to quickly tailor a system that meets each application’s unique requirements, without the cost of customization.  Standard modules and capabilities of the system include:

  • Complete “no-touch” processing of ready-to-use vials, syringes, and cartridges up to 100 containers per minute
  • Modules for bag and tub opening, automatic filling and closing, lyophilization, and vial capping
  • Multiple integrated barrier system options including Restricted Access Barrier Systems (RABS) and aseptic isolators

 

GENiSYS® R Robotic Small Batch Filling & Closing System

GENiSYS® R is an adaptive aseptic filling and closing equipment designed specifically to address the unique processing challenges posed by small-batch applications such as cell, gene, and regenerative therapies.  GENiSYS R has a unique blend of automated capabilities that maximize product yield and ensures each container is processed in strict accordance with cGMP requirements.  The system has the flexibility to easily handle variations in process requirements and container options alike.  With the ability to process ready-to-use vials, syringes, and cartridges, the GENiSYS R helps bring products to market quickly and cost-effectively.  Some of the capabilities and features of the GENiSYS R include:

  • Flexible filling and closing of ready-to-use vials, syringes, and cartridges up to 20 containers per minute
  • Perform 100% fill weight check with minimal reduction in overall output
  • Integrated modules for bag opening, automatic filling and closing, lyophilization and vial capping
  • Multiple integrated barrier system options including Restricted Access Barrier Systems (RABS) and aseptic isolators

 

GENiSYS® C

GENiSYS® C is the ultimate “multi-tool” for filling and closing vials, syringes, and cartridges with automated features typical of larger-scale filling machines.  It’s extremely compact footprint and advanced system features make this system an ideal solution for small batch filling applications like R&D, process development, niche products, clinical and commercial manufacturing.

  • Processing of vials, syringes, and cartridges up to 20 containers per minute
  • Advanced features such as IPC, environmental monitoring and electronic batch records
  • Flexible dosing options including peristaltic and rotary piston pumps
  • Compact cart system design makes installation easy within existing facilities with limited space

 

Applications Include

  • Small batch clinical and commercial product manufacturing
  • Drug product & process development
  • Gene & cell therapies
  • Compounding pharmacies

 

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