Isolator

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
  • ANFD Discharge Isolator
  • Reaction, Distillation,Filtration & Drying Isolator
  • Reactor Charging Isolator
  • Centrifuge Isolator

Formulation Isolator

  • Granulation Isolator
  • Milling & Sieving Isolator
  • QC Isolator
  • Pack off Isolator

Benefits

  • Operator safety
  • Alarms and safety measures in case of breach
  • Uncontaminated process media

Applications

  • Handling Cytotoxic drugs
  • Oncology drugs etc

Features

  • Laminar airflow Rugged SS 316 build
  • Interlocked door system
  • PLC controlled, Digital pressure controller to maintain a constant pressure.
  • Integrated Weighing Scale, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port and Drum loader
  • ISO 14644-1: class ISO 5
  • Integration with RTP for safe and rapid transfer
  • Containment breach alarm, low pressure and high pressure alarm, filter choked alarm etc.
  • Push-push type safe changeable HEPA filters
  • Integrated Clean In Place / washable to reach every corner of chamber
  • Oxygen monitoring / Nitrogen inertization
  • Turbulent air flow
  • Complete Documentation – FDS, DQ, FAT, IQ, OQ, OMM, Leak test, Lux, Noise, Air change, Filter integrity, Glove test, OEL etc.
  • Split Butterfly valve for safe transfer of material.

OEL (Occupational Exposal Limits) Categories

Categories
Hazard Description
OEL 1
Harmful, and / or low
pharmacological activity
OEL 2
Harmful, and / or moderate
pharmacological activity
OEL 3
Moderately toxic and / or high
pharmacological activity
OEL 4
Toxic and / or very high
pharmacological activity
OEL 5
Extremely toxic and / or
extremely high pharmacological activity

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