Vial Filling & Sealing Machine (ASEPTiCell r25)

Modular Aseptic Filling and Closing Machine

Vial filling and sealing machines are used primarily for filling, plugging and capping for small batches (clinical trials). At AST-inc we use medically sterilized rubber stoppers to maintain safety and sterility. Our Modular aseptic filling and closing machine has flexible capping and plugging arrangements with mechanical devices that are more stable and reliable with changeable capping heads for different caps.

Flexible Aseptic Production

The trend of pharmaceutical and biotechnology products requires flexible aseptic production systems that can efficiently process small to medium sized clinical and commercial batches without compromising quality.  The ASEPTiCell r25 provides unrivaled flexibility for aseptic production of ready-to-fill vials, syringes, and cartridges with a single machine.  ASEPTiCell r25 balance of flexibility and capabilities makes it an ideal solution for Contract Manufacturing Organizations (CMOs), compounding pharmacies, biotech, and pharmaceutical companies.

Isolator-Barrier Technology

ASEPTiCell r25 can be integrated with isolator-barrier technology to make the equipment the right choice for processing of aseptic, toxic and cytotoxic applications.  Integration with standardized process modules can expand system capabilities with semi-automated or fully automated functions to tailor the system to meet the unique needs of every application.  By leveraging our pre-engineered module designs and manufacturing approach provides a cost-effective solution that can be delivered with minimal lead-time.

Applications include:

  • Clinical trial and small batch manufacturing
  • Biologics, proteins and potent products
  • Patient specific therapies
  • Multi-product aseptic filling facilities
  • Filling and assembly of custom devices and containers

Benefits

  • Single integrated system automated aseptic processing of vials, syringes and cartridges
  • Robotic flexibility provides complete processing capabilities without the need of docking modules or trollies
  • No glass-on-glass or glass-on-metal contact eliminates common quality challenges
  • System can be integrated with multiple barrier-isolator options
  • Compact footprint minimizes cleanroom space requirements
  • Minimal format parts allows for rapid changeover increasing equipment productivity

Modular Design

The ASEPTiCell r25 is a multi-format production system that processes sterile injectables for the Pharmaceutical and Biotechnology industries.  The ASEPTiCell r25 innovative design leverages industry proven technologies such as robotics and isolator-barrier technology to fill and finish pre-sterilized, ready-to-fill vials, syringes and cartridges on a single platform.

The ASEPTiCell r25 modular design allows the filling machine to have additional process modules to be integrated to provide a tailored design for every application without the cost and risk of customization.  These modules can provide capabilities that include; bag opening, automated tub opening, lyophilizer loading / unloading and vial capping.  This modularity allows for a “plug and play” ability to add these capabilities upfront or in the future when the capabilities are required.

The compact system footprint keeps cleanroom space requirements to a minimum making it ideal for modular and existing cleanroom applications.  

 

ASEPTiCell™ SA is a compact aseptic filling system specifically designed for small to medium batch manufacturing of parenteral drug products. It is capable of filling, closing and sealing ready to use vials, syringes and cartridges on a compact, robotic platform at the highest levels of sterility assurance. It is the perfect solution for late stage clinical trials or commercial manufacturing of small to medium size batches of orphan drugs, tailored therapies and biologics.

Technical Information

Machine Model:

ASEPTiCell r25/i25

ASEPTiCell r50/i50

ASEPTiCell r100/i100

Approximate System Dimensions (LxWxH):

4850mm x 1800mm x approx. 2750mm

[190" x 71" x 108"] 

5325mm x 1800mm x approx. 3000mm

[210" x 110" x 118"] 

5325mm x 1800mm x approx. 3000mm

[210" 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

Production Rate:

Up to 25 containers per minute

Up to 50 containers per minute

Up to 120 containers per minute

Dispense Options:

Peristaltic & Rotary Piston

Filling Volume:

0.1mL to 250mL

Filling Accuracy:

Up to ±0.5%

Syringe / Cartridge Closing Method:

Vacuum & Vent-Tube (Mechanical)

Electrical Utilities:

230/480VAC - 50/60Hz.

Barrier System:

Restricted Access Barrier System (RABS) or Isolator

Restricted Access Barrier System (RABS) or Isolator

Restricted Access Barrier System (RABS) or Isolator

Module Options:

  • Automatic Bag Opening (ABO)
  • Automated Tub Opening (ATO)
  • Lyophilization Prep / De-Nesting Module (LPM)
  • Vial Sealing Module (VSM)

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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