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.
Send an enquiryKey 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 A | EU GMP |
|---|---|
| Annex 1 | EU GMP |
| ISO 5 | ISO 14644-1 |
| GAMP 5 | ✓ |
| 21 CFR Part 11 | FDA |
Need an isolator or RABS for your process?
Tell us about your product, process and cleanroom class — we will propose a configuration and send you a quotation.
