ASEPTiCell®

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® provides unrivaled flexibility for aseptic filling production of ready-to-fill vials, syringes, and cartridges with a single machine.  The ASEPTiCell® offers the right balance of flexibility with advanced system features to make it an ideal solution for Contract Manufacturing Organizations (CMOs), biotech and pharmaceutical companies.

The ASEPTiCell® 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

ASEPTiCell MachinePharmaceutical 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
Capabilities

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
  • Lyophilizer Integration

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)

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)

Applications:

  • 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
Benefits
  • 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
Technical Information

Machine Model:

ASEPTiCell®

Standard System Dimensions (LxWxH):

(ABO-ATO-FCM-VSM)

6603mm x 1700mm x 2000mm
[260" x 67" x 79"]

Containers:

Pre-sterilized vials, syringes, and cartridges

(Note: Tooling for non-standard/custom container formats available)

Vial Sizes:

2mL to 50mL (ISO 2R – 50R)

Syringe Sizes:

0.5mL to 50mL

Cartridge Sizes:

1mL to 20mL

Production Rate:

Up to 100upm

Dispense Options:

Peristaltic & Rotary Piston

Filling Accuracy:

Up to ±0.5%

Vial Closing Methods

Serum or Lyo stopper options

Vial Sealing Methods

Crimp or Press-fit capping options

Syringe / Cartridge Closing Method:

Vacuum, Vent-Tube, & Vent/Vac Combo

Barrier System:

Fully Integrated Restricted Access Barrier System (RABS) or Isolator

Materials of Construction:

Pharmaceutical grade stainless steel, plastics, and elastomers

Human-Machine Interface (HMI)

ASTView on a 21" color touchscreen

Module Options:

  • Semi-Automatic (SABO) or Automatic (ABO) Bag Opening
  • Automatic Tub Opening (ATO)
  • Automatic Fill/Close (FCM)
  • Lyophilization Prep / De-Nesting Module (LPM)
  • Vial Sealing Module (VSM)

Standard Options:

  • In-process fill weight verification (IPC) with automatic line purging and dynamic pump calibration
  • Viable and non-viable environmental monitoring (EM)
  • Electronic Batch Reporting (EBR)
  • Pre- & Post Fill Container Gas Purging

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.

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