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Pharmaceutical isolators

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AC-IS

Aseptic containment isolator

A Class A / ISO 5 aseptic containment isolation system, compliant with the strictest cGMP and international regulations, designed for sterile handling of highly potent active pharmaceutical ingredients (HPAPIs). Main components: PLC-controlled system, integrated VPHP generator and distribution circuit, VPHP-resistant anemometer and rH%+T sensor, AISI 304 external control panel, access panels with safety sensors, LED lighting. Options: VPHP sensors for TLV and in-chamber monitoring, integrated scales and terminals, high-containment split butterfly valves, RTP rapid transfer ports.

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Key features

  • Guaranteed sterility: HEPA/ULPA filtration, integrated VPHP bio-decontamination and inflatable seals
  • Strict containment: inflatable seals, negative pressure gradient and H14 HEPA filters
  • Automatic leak test of each chamber per ISO 10648-2 (pressure change method)
  • Integration of process equipment: dryers, reactors, scales, split butterfly valves
  • Ergonomic design for comfortable and safe operator work

Standards and compliance

Grade 2ISO 10648-2
OEL 5≤ 50 ng/m³
Class AEU GMP
ISO 5ISO 14644-1

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