Pharmaceutical isolator CIVAS-Assist

asepticfor hospitalsISO class 5

Product overview
This positive pressure aseptic isolator CIVAS-Assist is engineered for pharmacy compounding and aseptic handling of pharmaceutical products in an EU GMP Grade A / ISO 5 environment while providing a degree of operator protection. It is specifically suited to CIVAS (Central Intravenous Additive Service), TPN bagging, preparation of IV solutions and eye-drops, ampoule filling and comparable aseptic pharmacy tasks.

Key Features

• Positive pressure design to maintain product protection
• EU GMP Grade A / ISO 5 unidirectional airflow work area for aseptic processing
• Transfer chambers with timed electromagnetic interlocks to control material movement
• High air change rates in transfer chambers to suppress airborne contamination and accelerate disinfectant evaporation
• Automated pressure decay leak test with result indication and trend monitoring for periodic verification
• PLC-based controls for straightforward configuration, operation and maintenance
• Ergonomic access to potentially contaminated zones to facilitate cleaning and maintenance
• Safe primary exhaust HEPA filter replacement procedure
• Available in two-glove and four-glove configurations; offered in ducted (exhaust) and recirculating models

Applications
Designed for hospital pharmacies, sterile compounding units (including NHS hospital pharmacies) and other aseptic pharmacy environments for CIVAS compounding, TPN bagging, aseptic preparation of IV solutions and eye-drops, ampoule filling and related aseptic operations.

Technical specifications

• Positive pressure isolator providing product protection
• EU GMP Grade A / ISO 5 unidirectional airflow work area
• Transfer chambers with timed electromagnetic interlocks
• High air change rates in transfer chambers for contamination control and disinfectant evaporation
• Automated pressure decay leak test with result indication and trend data
• PLC controls for setup, operation and maintenance
• Ergonomic design enabling access for cleaning of potentially contaminated areas
• Safe procedure for primary exhaust HEPA filter change
• Choice of glove configurations (two- or four-glove) and airflow options (ducted or recirculating)