Pharmaceutical isolators
AP-IS Sampling
Aseptic sampling isolator for sterile powders
A cGMP Class A / ISO 5 aseptic isolation system, custom-built to handle large containers and bags and for sampling sterile powders (APIs). Engineered to the user’s specific requirements on the basis of the AP-IS series.
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.