Isolators

An isolator separates a work zone from the surrounding room with a rigid or flexible barrier and controlled airflow, so products, operators or both are protected from contamination. Aseptic isolators use a positive-pressure unidirectional flow through HEPA filters, optionally combined with a vaporized hydrogen peroxide (VHP) cycle and rapid transfer ports, for cell culture, microbial work, sterile compounding and aseptic processing. Cell therapy isolators add a CO2/O2 incubator and microscope under vertical unidirectional airflow holding a grade A zone, plus SCADA monitoring with electronic records for GMP-regulated advanced therapy production. Negative-pressure isolators hold the zone below room pressure so hazardous or infectious materials cannot escape, with emergency response on pressure loss and optional decontamination and waste liquid handling. Filling isolators are built for sterile, highly potent or highly active products: segmented chambers with independent pressure gradients and leak testing, VHP cycles per segment, vial and pre-filled syringe handling on one line, rapid transfer ports, glove leak testing and optional WIP/CIP washdown.

Features

• Physical barrier with positive or negative pressure and HEPA-filtered unidirectional airflow.
• VHP decontamination cycles and rapid transfer ports for material entry.
• Cell therapy versions integrate a CO2/O2 incubator and microscope with SCADA monitoring and electronic records.
• Filling versions run segmented pressure gradients with independent leak tests and glove leak testing.
• Negative-pressure versions add emergency response on pressure loss and waste liquid handling options.

Applications

• Aseptic processing and sterility testing in pharmaceutical plants
• Cell and gene therapy and regenerative medicine production
• Handling of potent, cytotoxic or infectious compounds
• Hospital pharmacies and microbiology laboratories