Compliance & Standards :
- CGMP
- WHO-GMP
- EU-GMP
- ISO 14644
- FDA 21 CFR Part 11
IPQC ISOLATOR
IPQC Isolator is designed for safe and controlled in-process quality checks during pharmaceutical manufacturing. It provides a contamination-free environment for sampling, weighing, and analytical testing of intermediate products. The isolator protects operators from potent materials while ensuring sample integrity and accuracy of results. Ideal for production lines requiring high containment, sterility, and consistent quality monitoring under strict GMP conditions.
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
