Vial Filling Equipment - ASEPTiCell i100

Aseptic Filling

Aseptic filling is the process of taking a sterile (aseptic) product and packaging it in a sterile container, such as a vial, syringe or cartdrige, in a way that maintains sterility.

The trend of pharmaceutical and biotechnology products requires flexible aseptic production systems that can efficiently process medium sized clinical and commercial batches without compromising quality.  The ASEPTiCell i100 provides unrivaled flexibility for aseptic filling production of ready-to-fill vials, syringes, and cartridges with a single machine.  ASEPTiCell i100 provides the right balance of flexibility with advanced system features to make it an ideal solution for Contract Manufacturing Organizations (CMOs), biotech and pharmaceutical companies.

ASEPTiCell i100 can be integrated with isolator-barrier technology to make the equipment the right choice for processing of aseptic, toxic and cytotoxic applications.  Integration with advanced process features such as automated bag and tub opening, statistical or 100% in-process fill weight control provide a completely automated “hands-off” system from start to finish.

Vial Filling Equipment

Pharmaceutical vial filling equipment plays an important role in production; filling of vials and bottles in a sterile and safe environment. This type of equipment ensures that quality control is maintained throughout the production process, decreasing product loss and more importantly to make sure volume levels stay consistent.  

Syringe Filling

In today's pharmaceutical market the trend is leaning more towards prefilled syringes. Patients benefit greatly from healthcare professionals that can provide a safe and consistent product. Pharmaceutical companies can also provide a diverse product line the market sorely needs.

Why a Prefilled Syringe?

  • Safety - eliminates the risk of needle stick injuries, cross contamination, and cross infection
  • Very easy to use and cuts down on administration steps
  • Consistency and security of dosage amounts

Business Advantages

  • Savings - reduced product waste in clinical trials versus vials
  • Simple storage and disposal
  • product diversity versus vials

Applications include:

  • Small to medium batch production of commercial and clinical materials
  • Biologics, proteins and potent products
  • Multi-product aseptic filling facilities
  • Filling of potent, toxic and cytotoxic materials
  • Filling and assembly of custom devices and containers

Benefits

  • Single integrated system automated aseptic processing of vials, syringes and cartridges
  • Advanced automated features fully automate the production process to provide “hands off” operation
  • 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
  • Minimal format parts allows for complete line changeover in as little as thirty minutes
  • Integrated in-process fill weight control provides real-time fill weight measurement for statistical sampling or each container
  • Standard line options available with quick delivery

Advantages of ASEPTiCell i100

The ASEPTiCell i100 is a multi-formation aseptic fill-finish system specifically designed for pharmaceutical and biotech products.  The ASEPTiCell i100 integrates proven industry technologies such as robotic and isolator-barrier technology to fill and finish pre-sterilized, ready-to-fill vials syringes and cartridges on a single platform.  In addition to these core system features, automated bag and tub opening, statistical and 100% in-process fill weight verification and vial capping completely automate the aseptic fill-finish process.  This “hands off” solution enhances system productivity, and controls contamination risk by minimizing operator interventions to the greatest extent possible.

The innovative implementation of robotics provides unique advantages that minimize cleaning effort, air flow disruption over open containers, and wasted drug product.  The robotic filling allows for statistical and 100% in-process fill weight measurement with each container being filled directly on the load cell in real-time.  Upon completion of the filling process the container is immediately closed.

Downstream operations downstream of the ASEPTiCell i100 can include lyophilizer loading and unloading and vial capping depending upon product and application requirements.

Technical Information

Dimensions (LxWxH)

1346mm x 61mm x approx. 2500mm

Products:

Liquid & lyophilized pharmaceuticals

Containers:

Pre-sterilized vials, syringes and cartridges

Vial Sizes:

2mL to 50mL (ISO 2R – 50R)

Syringe Sizes:

0.5mL to 20mL

Cartridge Sizes:

3mL

Production Rate:

Up to 7200 units per hour

Dispense Options:

Peristaltic & Rotary Piston

Filling Volume:

0.1mL to 100mL

Filling Accuracy:

Up to ±0.5%

Electrical Utilities:

480/220VAC – 60/50Hz.

Available Options:

  • Containment isolator
  • In-process fill weight verification (IPC)
  • Electronic Batch Reporting (EBR)
  • Automatic Bag Opening
  • Automatic Tub Opening
  • Nested vial sealing
  • Lyophilizer integration

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