QC isolators
ST-IS Beta
Sterility testing isolator for beta emitters
A cGMP Class A / ISO 5 isolation system for quality control laboratories, pilot-scale pharmaceutical production and pharmacies. A flexible machine for sterility testing, filling, fractionation, sampling and aseptic product transfer, with specific configurations for beta emitters. Filtration uses HEPA pre-filters and ULPA U15 unidirectional and return filters; a complete VPHP cycle in the rapid pre-chamber takes about 20 minutes including ventilation.
Send an enquiryKey features
- Modular design: 3–4-glove work chamber expandable with modules and options
- Guaranteed sterility: HEPA/ULPA filtration, integrated VPHP bio-decontamination and inflatable seals
- Automatic leak test of each chamber per ISO 10648-2 (pressure change method)
- PLC control with 12″ touch-screen HMI and intuitive graphics
- Ergonomic design for comfortable and safe operator work
- Very low energy consumption thanks to low-voltage fans
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.