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.
Overview
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
Functionality
The laminar air flow in the material locks takes place with supply and exhaust air via upstream and downstream HEPA filters H14. The doors are magnetically locked against each other and monitored. Each time the door is opened, there is a fixed flushing time with a > 100-fold air exchange rate, which ensures that airborne particles in the airlock are discharged quickly.
The controlled supply air in the isolator chamber generates a defined constant flow without turbulence. WIBOsafe isolators thus meet the requirements of clean room class A according to EU GMP and ISO class 5 in accordance with ISO 14644-1.
Depending on requirements, the air flow system can also be converted to negative pressure.
