Compliance & Standards :
- cGMP
- WHO-GMP
- EU-GMP
- ISO 14644
- FDA 21 CFR Part 11
GRANULATION ISOLATOR
Granulation Isolator provides full containment for wet and dry granulation processes. It maintains a controlled environment to prevent dust generation, cross-contamination, and operator exposure. Suitable for handling potent APIs, this isolator delivers safe granulation while ensuring regulatory compliance and process consistency.
Applications :
- Sterile drug manufacturing and aseptic processing
- Compounding and material handling in pharma production
- Handling of hazardous, potent, or sensitive biological materials
- Hygienic processing for food and nutraceutical sectors
- Contamination-free microelectronics and semiconductor assembly
Key Features:- ISO Class 7 (Grade C) cleanroom classification at rest
- Operates under -80 to -120 Pa negative or positive pressure
- ISO Class 3 containment (ISO 10648-2)
- Dual HEPA/ULPA filters with 99.99% efficiency at 0.3 µm
- VHP (Vaporized Hydrogen Peroxide) compatible sterilization
- SS 304 / SS 316L seamless constructions
- Ergonomic design with smooth, rounded corners
- Touchscreen PLC-based HMI with real-time monitoring
- Interlocked doors and intrinsically safe design
- Chemical-resistant glove ports with optional glove leak test
- Automated leak test cycle before each batch
