Filling Line Isolator

• ISO Class 5 air cleanliness classification as per ISO 14644-1
• Factory-configured to operate in a positive or negative pressure regime, depending on client requirements.
• Configured to operate in single pass/total exhaust or recirculating airflow
• Unidirectional airflow
• Turbulent airflow
• Automated Pressure Hold Test
• With on-board compressed air supply
• With client supplied compressed air
• Biodecontamination System
• Esco Pharma’s BioVap™ biodecontamination cycle ensures a 6 log reduction in bioburden.
• Audio/Visual Alarm System
• Touch-Panel Interface
  • Siemens HMI/PLC
  • Allen-Bradley PLC
• Surface Finish Options:
  • Grained Finish-Directional
  • Orbital Finish-Upcharge Required
• Barrier Technology:
  • Restricted Access Barrier System (RABS)
    • Material Entry
    • Closing oRABS
      • Both operate in ISO Class 5 environment and can be configured in positive or negative pressure depending on the application.
  • Isolator
    • Filling Line Isolator
      • Allows the introduction of stoppers and fill media via closed transfer ports
    • Lyophilizer Isolator
      *Dependent on client requirements
      • Facilitates in the loading and unloading of the lyophilizer.
      • With ISO Class 5 air quality inside via laminar airflow
      • The lyophilizer is pressure-tested as a combined system with the isolator
      • Automated entry/exit door system
      • Rapid Transfer Port (RTP) rapid upgrade capability
      • With clean gasket finish
• Channel with fill-line base
  • Able to accommodate multiple filling line base types:
    • Full Stainless Steel
    • Stainless Covred Aluminum Base
  • Repeated fitment (no damaged gasket)
  • Guaranteed air-tight sealing
  • Flush/Smooth crevice-free transition between filler base and isolator shell
• Single Wall or Double Wall design
  *Dependent on client requirements
  • Single Wall design-Remote HVAC Skids
  • Double Wall design-Remote HVAC Skids
  • Double Wall design-Non-Remote HVAC Skids
• Heating, Ventilation, and Air Conditioning (HVAC) system
  • Remote
  • On-board
• Cleaning Processes
  • Wash-in-Place (WIP)
  • Clean-in-Place (CIP)
• Integrated systems for filling process
  • Vial washer
  • Depyrogenation tunnels
  • Automatic loading/unloading system
  • Automated tub conveyor and Automated nest transporter
  • Filling/Stoppering Inserting Machine
  • Lyophilizer
  • Robotic Arm (for filling, stoppering, and capping)

Disclaimer
Esco does not manufacture stand-alone filling lines, rather, it is always in combination with Esco’s isolators or with open/close restricted access barrier systems (o/cRABS).
When necessary, Esco can: do the front end engineering design, ergonomic trials, URS write-up, and coordinate with its various partners for the provision of a full integrated system (Isolator + Filling lines + Freeze Drier + Auto-loading/unloading system) or provide a full integrated system according to client URS.
Esco also has an option to link the complete system to the client’s SCADA/DCS system (PCS7, DeltaV, Wonderware or others) for eBatch records and eSignatures in compliance to GAMP 5, 21 CFR Part 11 compliance with computer systems validation.

Esco Pharma's prized isolation technology can be configured at either positive or negative pressure with a unidirectional/laminar recirculating or total exhaust airflow regime; depending on the process and the material to be handled by the clients.

The isolator can house a whole filling line system for the production of sterile liquid and/or semi-solid pharmaceuticals. The components for the construction of this technology are modular and can be upgraded easily, very unlike traditional manufacturing.

Similar to Esco’s individual isolators utilizing unidirectional laminar airflow, the filling line isolator has its fan filter units (H14 filters) responsible for ensuring the sterility of the work zone. It is also pressure tested in the factory and can be programmed (via PLC controller) with its own automated pressure hold testing to guarantee that there are no leaks in system.

Additionally, the integration of the BioVap™ biodecontamination system also ensures the prevention of cross-contamination risks. During the biodecontamination process, about 30% of hydrogen peroxide (H₂O₂) mist is injected into the work zone, hence ensuring a 6 log reduction in bioburden.

Esco is equipped with the experience and the know-how to successfully integrate modular and innovative manufacturing technologies into your existing facilities; ensuring a safe and cost-effective way of advancing your processes.

There are two main types of Filling Line technologies

• Traditional Filling Line System

  • Are single format dedicated lines often with pre-preparation (washing/sterilization tunnels), to process glass vials, cartridges, and syringes.

    • Non-Robotic

    • Robotic

• Flexible Multi-format Ready-to-Use (RTU) Filling Line System

  • Integrates the best industry technologies to simplify the manufacturing process. It utilizes flexible ready-to-use and single-use consumables, thus, removing container preparation process at the manufacturing site. It can also cater to multi-format containers and sizes on a single modular platform.

    • Single Format

      1. Non-Robotic

      2. Robotic

    • Multi-Format

      1. Non-Robotic

      2. Robotic

• Traditional Filling Line System

  • Rotary Washer

  • Depyrogenation Tunnel

  • Filler

  • Stoppering/ Partial Stoppering

  • Loading / Unloading and Freeze Drier

  • Capper

  • External Washer

• Flexible Multi-format Ready-to-Use (RTU) Filling Line System

  • RTU consumables

  • Single-Use Disposable Components:

    • Mixing bag/Holding bag

    • Pre-filtration sampling bags

    • Reservoir bags

    • Aseptic connections/assemblies

  • Automated Tub Conveyor & Automated Nest Transporter

  • Robotic Arm (filling, stoppering, and capping)

  • External Vial Washer

  • Additional Features

    • Stopper gap detection system

    • Quarantine location

    • Inspection and labelling system

    • Viable monitoring (active and passive)

    • Modular in-situ configuration to have changeable parts to fill multiple container formats (e.g. RTU vials/ syringes/cartridges/IV bags)

Disclaimer
Esco does not manufacture stand-alone filling lines, rather, it is always in combination with Esco’s isolators or with open/close restricted access barrier systems (o/cRABS).
When necessary, Esco can: do the front end engineering design, ergonomic trials, URS write-up, and coordinate with its various partners for the provision of a full integrated system (Isolator + Filling lines + Freeze Drier + Auto-loading/unloading system) or provide a full integrated system according to client URS.
Esco also has an option to link the complete system to the client’s SCADA/DCS system (PCS7, DeltaV, Wonderware or others) for eBatch records and eSignatures in compliance to GAMP 5, 21 CFR Part 11 compliance with computer systems validation.