Bottle Filling Line Isolators

Bottle Filling Line Isolators

Today, Barrier Isolator systems are an essential and important item of equipment in the pharmaceutical industry.

The advantages of a well-engineered barrier isolator over a conventional clean room facility include;

  • more effective process control
  • improvement in product quality
  • the reduction of operating costs
  • capability of longer, more efficent production runs

Complex filling lines require competent management of the interaction between filling machine, isolator system and subsequent machines, e.g. freeze-drying systems or overseal capping machines.

The challenges facing pharma-engineers include;

  • reliable operation
  • the safe functioning of the interfaces
  • the simplicity of the overall controls system
  • ease of operation of the individual components
  • equipment maintenance and service friendly

Schematic Engineering Industries provide Turnkey Isolator Solutions and can offer full bottle filling systems, including conveyor and integrated automation, from a single supply source.

These barrier isolators seamlessly integrate with the clients bottle filling machine and conveyor system, as shown to the right.

Design Features

  • Uni-directional laminar flow
  • H14 HEPA filtration
  • 21 CFR Part 11 ready
  • Large oval gloveports
  • Temp. & RH monitoring/control
  • cGAMP - PLC/HMI controlled

Technical Specification

  • ISO 14644-1: class ISO 5 (Class 100, Grade A)
  • 21 CFR Part 11 ready
  • Rigid Stainless Steel Construction
  • Containment breach and Filter choked alarms
  • Low pressure and high pressure alarms
  • Interlocked door system and H14 HEPA filtration
  • Light Vacuum (100 Pa) system
  • Integrated conveyorsystem
  • Temperature and Humidity (RH) monitoring/control
  • cGAMP - PLC/HMI controlled
  • Isolator system is designed to achieve a minimum of ISO 4.8 (Grade A) classification (Optional).
  • Supplied to all OEL Categories OEL 1-5

Operational Benefit

  • Integrates with 3rd party filling lines
  • Adheres to regulatory standards
  • Reduced risk of human intervention
  • Improves filling line operation/performance

Applications

  • Aseptic Filling Lines

Supply Options

  • Integral Bio-decontamination (Optional)

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