Pharmaceutical isolator SEI line

asepticfor sterility testingfor clean rooms

SEI line isolators are engineered to establish a confined sterile environment for sensitive aseptic and sterility-critical operations. They deliver controlled laminar airflow, contamination protection and provisions for integration of decontamination and environmental monitoring systems.

Key features

• Work chamber with laminar flow and ULPA filtration, U16 class, compliant with ISO 5.
• Available with 2, 3 or 4 glove ports; one or multiple transfer chambers (pass boxes) in turbulent flow, with or without glove ports.
• Pneumatic seals and door interlocks for containment and safety.
• Internal pressure control and filter integrity monitoring with integrated alarms to protect the internal volume and, where required, the external environment.
• Provision for mounting sterility testing equipment.
• Integration or provision for VHP (vaporized hydrogen peroxide) decontamination systems.
• Provision for particle counters and H2O2 measurement devices.
• Modular construction enabling addition of sections without major technical interventions.

Standards and compliance

• ISO 10648-1 and ISO 10648-2: design, construction and testing criteria for glove boxes and isolators (containment/sealing).
• ISO 14644-7: airborne particle contamination — laminar flow in small enclosures such as isolators and glove boxes.
• Additional references: ISO 14644-1:2015, ISO 14644-3:2005 and EU GMP - Annex 1 (air cleanliness classification and good manufacturing practice).

Technical characteristics / specifications

• Chamber type: laminar flow (ULPA, U16) – ISO 5 class.
• Glove configurations: 2, 3 or 4 glove ports.
• Transfer chambers (pass boxes): turbulent flow, various sizes, with or without glove ports.
• Safety: pneumatic seals, door interlocks, alarms.
• Controls: internal pressure monitoring and filter integrity checks.
• Decontamination: provision/integration for VHP.
• Environmental monitoring: provision for particle counting and H2O2 measurement.
• Construction: modular, expandable without major technical work.
• Applicable standards: ISO 10648-1, ISO 10648-2, ISO 14644-7, ISO 14644-1:2015, ISO 14644-3:2005, EU GMP - Annex 1.