The sterile isolator ISI physically separates operators from production processes by maintaining a positive pressure environment within its chamber and adhering to Class A cleanliness standards. Its fully enclosed operating environment significantly minimizes external contamination risks, providing a consistently stable clean space for sterile production and inspection operations. This effectively prevents cross-contamination of products during these procedures.
The enclosure is constructed entirely of stainless steel, featuring a tempered glass door with an inflatable seal to ensure environmental containment and maintain pressure levels during sterile operations within the work area.
The interior chamber is equipped with dustproof and waterproof sockets and a high-pressure water gun. Optional accessories include a glove leak detector and an online particulate and airborne microbial sampling system.
It continuously provides a controlled Class A sealed environment, meeting requirements for sterile production or inspection, and solves the challenge of maintaining Class 100 cleanliness in traditional sterile rooms.
Real-time monitoring of operational parameters such as air velocity and pressure differential ensures the chamber fully complies with GMP Class A cleanliness standards. Laminar airflow moves downward, guaranteeing uniformity and minimizing contamination risks.
| Item | Parameter |
| Enclosure Material | SUS304 |
| Filter Efficiency | H14 (EN1822) |
| Cleanliness Grade | ISO Class 5 (Class 100) |
| Noise Level | <65 dB(A) |
| Supply Air Velocity | 0.36 ~ 0.54 m/s |
| Differential Pressure Gauge | DWYER Digital Display |
| PLC | Siemens |
| Touchscreen | Siemens |
| Power Supply | AC 220V/50Hz |
| Swivel Casters | Polyurethane |