Production isolator CIVAS ABD

for the pharmaceutical industryasepticISO class 5

OverviewOur CIVAS ABD positive-pressure gassing isolator is designed for aseptic pharmaceutical handling with an integrated Vaporised Hydrogen Peroxide (VHP) decontamination system validated to deliver a 6-log sporicidal reduction. The unit operates as a closed-loop configuration, requiring no external ducting or room modifications, and supports compliance with Annex 1 guidance for aseptic processing.

Applications

• CIVAS (Central Intravenous Additive Service)
• TPN compounding and bagging
• Preparation of IV solutions and ophthalmic drops
• Ampoule filling and parenteral dispensing

Key Features

• Positive-pressure isolator design to protect product during aseptic operations
• Integrated Vaporised Hydrogen Peroxide (VHP) system capable of 6-log sporicidal kill
• Closed-loop configuration — no external ducting or room modifications required
• Fully automated lids and valves with automated pressure decay testing
• EU GMP Grade A unidirectional airflow work area (ISO 5 equivalent)
• Transfer chambers with electromagnetic timed interlocks and high air-change rates for contamination control
• Accessible internal surfaces to facilitate cleaning and maintenance
• Safe primary exhaust HEPA replacement procedure
• Internal surfaces in polished 316L stainless steel for VHP resistance
• Siemens TP700 Comfort HMI with PLC controls for enhanced connectivity
• Available in two-glove and four-glove configurations; ducted or recirculating airflow options; customizable working area width; optional extra exhaust fans/filters

Technical specifications

• Model series: CIVAS ABD
• Containment type: Positive-pressure isolator for aseptic pharmaceutical handling
• Bio-decontamination: Integrated VHP (vaporised hydrogen peroxide) system — validated, capable of 6-log sporicidal reduction
• Airflow classification: EU GMP Grade A unidirectional airflow work area (ISO 5 equivalent)
• Construction materials: Internal surfaces in polished 316L stainless steel for VHP resistance
• Transfer systems: Transfer chambers with electromagnetic timed interlocks and high air-change rates
• Filtration: Primary exhaust HEPA with safe replacement provisions
• Controls: Siemens TP700 Comfort HMI Panel integrated with PLC controls
• Automation: Automated lids and valves; automated pressure decay testing
• Configurations: Two-glove or four-glove versions; ducted or recirculating airflow options; customizable working area width; optional extra exhaust fans and filters
• Installation: Closed-loop configuration — no external ducting or room modifications required