Pharmaceutical isolator SEI line STERILITA'

asepticcontainmentfor sterility testing

SEI line sterility isolators are designed to create a confined area with maintained and monitored sterility. The work chamber operates in laminar flow (ULPA U16 filter, ISO 5 class) and the isolators are built with a modular structure for possible addition of sections.

Main functional features

• Work chamber in laminar flow with ULPA U16 filter (ISO 5).
• Available configurations with two, three or four glove ports.
• Pre-chamber(s) of various sizes with turbulent flow, with or without glove ports.
• Pneumatic seals and door interlocks to protect against contamination.
• Internal pressure control and filter integrity alarm systems.
• Provision for mounting systems to perform sterility testing.
• Possible integration of VHP decontamination system (or pre-integrated solution).
• Provision for mounting particle counting and H2O2 measurement equipment.
• Modular structure allowing addition of sections without major technical interventions.

Reference compliance standards

• ISO 10648-1
• ISO 10648-2
• ISO 14644-7
• ISO 14644-1:2015
• ISO 14644-3:2005
• EU GMP - Annex 1 (EC Guide to Good Manufacturing Practice)

Features / technical specifications

• Filter: ULPA U16.
• Work chamber air cleanliness class: ISO 5 (laminar flow).
• Glove options: 2, 3 or 4 ports.
• Pre-chambers: turbulent flow, with or without glove ports.
• Sealing systems: pneumatic seals and door interlocks.
• Monitoring: internal pressure control and filter integrity alarms.
• Decontamination: provision/integration for VHP.
• Control instruments: provision for particle counter and H2O2 measurement.
• Structure: modular, expandable.