AUTOMATIC ASEPTIC FILLING ISOLATOR – AFL Series – TAILIN

Origin: China

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The Aseptic Filling Isolator features a three-chamber design, comprising a transfer chamber, filling chamber, and capping chamber. An integrated Vaporized Hydrogen Peroxide (VH₂O₂) sterilization system enables the chambers to be sterilized either individually or simultaneously.

With modular assembly and automated production, the system improves aseptic preparation efficiency while minimizing the risk of contamination during the filling of aseptic preparations and ATMPs.

Custom configurations are available to meet specific customer requirements.

Advanced Protection for Aseptic Filling Processes

The Aseptic Filling Line Isolator is a custom-designed cGMP Grade A / ISO 5 containment system for critical processes such as aseptic filling, stoppering and capping. It is designed for batch pharmaceutical production of injectable products, helping minimize contamination risks from the external environment.

Key Features

  • cGMP Grade A / ISO 5 environment for reliable sterility assurance
  • H14 HEPA filtration for both air intake and exhaust
  • Integrated VH₂O₂ sterilization system with precise concentration and saturation control
  • Fully enclosed chambers with GMP-compliant inflatable silicone seals
  • Real-time environmental monitoring of microbial contamination, airflow velocity, differential pressure, humidity and temperature
  • 21 CFR Part 11-compliant control system with multi-level access, audit trail and e-signature
  • Automated leak testing for individual chambers according to ISO 10648-2
  • Automated glove integrity testing according to ISO 14644-7, detecting glove holes down to 100 μm
  • Complete data management and traceability with real-time recording of the filling process
  • Ergonomic design for comfortable operation and improved efficiency
  • Easy maintenance and remote support through an integrated control module
  • Customizable modular configuration to meet specific production requirements
  • Energy-efficient operation, with low-voltage inverter-controlled ventilation fans and the option to operate in a Class D background environment

Optional Configurations

  • BIBO filter system for radioactive, toxic or bacteriological particles
  • DPTE rapid transfer system
  • Aseptic liquid through-wall connection system
  • Catalytic VH₂O₂ decomposition for safe external and internal discharge
Air flow: Vertical unidirectional laminar flow VH2 O2 Leakage: ＜1ppm (around the isolator during sterilisation)
Cleanliness Level: GMP Grade A Control System: Siemens PLC control,12″ Siemens industrial panel PC
Sterility Assurance Level: ≥6-log kill Noise: ＜75dB(A
Lighting: LED lamp, 500lux Power Supply: AC380V/50Hz
Airtightness: leakage rate is less than 0.5% volume/hour at 2 times working pressure

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