Pharmaceutical isolator

asepticsterilefor production

Overview
The Envair Technology Aseptic Processing Isolator is engineered for sterile production environments requiring EU GMP Grade A conditions and enhanced operator protection. Designed and documented to support cGMP and GAMP 5 guidelines, the isolator integrates control, monitoring and alarm functions to maintain product integrity during critical filling and handling operations.

VHP Decontamination
Optional integrated vaporised hydrogen peroxide (VHP) system provides automated bio-decontamination. The gassing function executes repeatable sterilisation cycles and is validated to achieve a consistent six-log reduction in microbial spores, with cycle control and records to support validation and routine operation.

Key Features

• Unidirectional airflow delivering 0.45 m/s at the work zone with minimal fluctuation
• Siemens S7-1500 PLC with TP700 Comfort HMI touchscreen for system control, monitoring and alarm management
• Automatic inflating silicone door seals to ensure airtight integrity during operation
• Integrated internal CCTV for continuous observation of filling operations without process interruption
• Removable stainless steel work trays for rapid cleaning and changeover
• Energy-efficient design using EC fans and LED lighting to reduce power consumption
• Automatic pressure decay testing to verify enclosure integrity before each batch
• Optional integrated VHP decontamination validated to achieve six-log spore reduction

Technical specifications

• EU GMP Grade A work area
• Unidirectional airflow at 0.45 m/s
• Siemens S7-1500 PLC with TP700 Comfort HMI touchscreen
• Integrated VHP automated bio-decontamination (optional), validated six-log reduction
• Automatic inflating silicone door seals
• Internal CCTV for process observation
• Stainless steel removable work trays
• EC fans and LED lighting for energy efficiency
• Automatic pressure decay testing capability
• Designed to meet cGMP and GAMP 5 guidelines