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AP-IS

Pharmaceutical isolators

AP-IS

AP-IS

Aseptic processing isolator

A Class A / ISO 5 cGMP isolation system for quality control laboratories, pilot-scale pharmaceutical production and pharmacies. A flexible machine for sterility testing and filling, fractionation, sampling and aseptic product transfer. It combines high containment and air quality with flexibility; the modular configuration adapts the isolator to specific processes, while integrated environmental control and integrity monitoring ensure reliable, repeatable processes.

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Key features

  • Guaranteed sterility: HEPA/ULPA filtration, integrated VPHP bio-decontamination and inflatable seals
  • Unidirectional (laminar) airflow with recirculation in the work area
  • Automatic leak test of each chamber per ISO 10648-2 (pressure change method)
  • Aseptic filling, sterility testing, dispensing, sampling and transfer
  • Modular design: 3–4-glove work chamber expandable with modules and options
  • Ergonomic design for comfortable and safe operator work

Standards and compliance

Class AEU GMP
Annex 1EU GMP
ISO 5ISO 14644-1
GAMP 5✓
21 CFR Part 11FDA
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