Possible contamination due to exposure of clean-room environment or personnel to process media can be unacceptable in high toxic applications. An Isolator unit under light vacuum (100 Pa) that provides uncompromised and continuous isolation of its interior from the external environment is necessary in this case.
API Isolator types:
- Dispensing & Sampling Isolator
- Reactor Charging Isolator
- ANFD Discharge Isolator
- Centrifuge Isolator
- Reaction, Distillation,Filtration & Drying Isolator
- Granulation Isolator
- QC Isolator
- Milling & Sieving Isolator
- Pack off Isolator
- Operator safety
- Uncontaminated process media
- Alarms and safety measures in case of breach
- Handling Cytotoxic drugs
- Oncology drugs etc
- Laminar airflow
Rugged SS 316 build
- Containment breach alarm, low pressure and high pressure alarm, filter choked alarm etc.
- Interlocked door system
- Push-push type safe changeable HEPA filters
- PLC controlled, Digital pressure controller to maintain a constant pressure.
- Integrated Clean In Place / washable to reach every corner of chamber
- Integrated Weighing Scale, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port and Drum loader
- Oxygen monitoring / Nitrogen inertization
- Turbulent air flow
- ISO 14644-1: class ISO 5
- Complete Documentation – FDS, DQ, FAT, IQ, OQ, OMM, Leak test, Lux, Noise, Air change, Filter integrity, Glove test, OEL etc.
- Integration with RTP for safe and rapid transfer
- Split Butterfly valve for safe transfer of material.
OEL (Occupational Exposal Limits) Categories
||Harmful, and / or low
||Harmful, and / or moderate |
||Moderately toxic and / or high |
||Toxic and / or very high |
||Extremely toxic and / or |
extremely high pharmacological activity