Type A isolator WIBOsafe

asepticISO class 5with HEPA filter

WIBOsafe aseptic isolators offer safe product protection when processing sensitive materials and during aseptic production. The targeted air flow creates a defined positive pressure that prevents the ingress of particles in the event of leakage and thus protects the products from contamination. Depending on requirements and work processes, the isolator can be designed modularly and ergonomically with one or more isolator chambers and material locks. The WIBOsafe isolators for aseptic processes from Weiss Pharmatechnik fulfill clean room class A according to EU GMP. Room parameters such as air flow, room pressure, temperature, and humidity are continuously monitored in order to ensure the consistent quality of the production process. The isolator also has integrated germ and particle monitoring. The processes are monitored and controlled via a touch panel. The work area can be fitted with various equipment such as compressed air, pumps, and cable entries. An H₂O₂ decontamination (6-Log) and an H₂O₂ catalyst for reducing the H₂O₂ content with the necessary monitoring are included as standard. Air purity according to EU GMP clean room class A (ISO class 5) Laminar airflow with air velocity of 0.45 m/s ± 20% Product exposure < 0.2 µg/m³ Circumferential sealing of the panes and lock doors Tightness class according to ISO EN 14644-7: 3-4 Suitable for hazardous substances up to OEB 6 H₂O₂ decontamination with H₂O₂ catalyst