Containment Isolator

Containment isolator is designed for protecting the operators when weighing, dispensing, drying, pressing, filling highly potent and toxic products.

OEB 4 or OEB 5: Provides high-level operator exposure protection for potent compound handling.
H14 Cylinder HEPA Filters (PUSH-PUSH): Ensures efficient air filtration and easy filter replacement without contamination.
Continuous Liner Bag System: Enables safe and contained material transfer to prevent product or operator exposure.
Control System: Siemens PLC control with HMI for reliable, user-friendly operation.

Automation: Fully automatic control and operation, reducing manual intervention.
Real-time Monitoring: Continuously monitors differential pressure, humidity, and temperature for consistent performance.
Data Management: Critical process parameters can be stored and printed for validation and traceability.
Regulatory Compliance: Fully complies with 21 CFR Part 11 requirements for electronic records and signatures.

Power supply: 220V 50Hz

Chamber Material: SUS316L

Airflow model: Turbulent

Chamber Pressure: -80Pa to 50Pa adjustable

Air changes rate: More than 24 times/hour

Noise: <65dB(A) during negative pressure holding

Leak tightness: Meet ISO10648-2 requirements

Laminar flow with Bag-in-Bag-out H14 HEPA filters
Explosion-proof
The vibration-free platform for precision weighing
WiFi-controlled glove integrity tester (GIT-WLAN)
Wooden Mock-Up

Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11

FAT, SAT, Training

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