Aseptic isolator ISO5-Petra

for nuclear medicinefor radioisotope preparationfor radiopharmacy

Shielded isolator designed for use with beta-emitting therapeutic isotopes (e.g. 90Y, 177Lu), manufactured in pharmaceutical-grade AISI 316L stainless steel with integral lead (Pb) shielding and PMMA lining in the handling and waste zones to stop beta particles.

Main functional areas

• ISO5 main handling area compliant with ISO 14644-7, housing the Synthesis Module for manipulation and synthesis of radiopharmaceuticals under sterile, controlled conditions to ensure final product sterility and radiological protection for staff and environment.
• Side pass-through chamber for introduction and removal of vials, preparations, materials and small tools.
• Under-bench pass-throughs: one service chamber housing the dose calibrator port and waste area; one chamber under the synthesis module for installation of 2 Ga-68 generators.

Other features

• Pneumatically operated doors with interlock safety system.
• Pass-through filtration with absolute HEPA H14 filters.
• Internal LED lighting and UV lamp.
• Gas feedthroughs and sealed cable passages; internal power outlets.
• LED signal column with visual and acoustic alarm.
• Front PMMA viewing panel, pneumatically sealed with gasket, flanged pass-throughs and gloves; external hinged stainless steel front, shielded, manually interlocked opening with shielded ports and pass-through hatch, anti-X viewing window.
• Integrated internal radiation detector and external control unit for safety monitoring.
• Siemens touch control panel and pressure gauges for direct display of operating pressures.
• Integrated particle counter with management software to continuously monitor ISO grade according to GMP and FDA requirements.
• Compliance with GMP, GLP, GAMP, NBP, CFR21 guidelines.
• IQ/OQ validations included.

Characteristics / technical specifications

• Structure material: AISI 316L stainless steel (pharmaceutical grade).
• Shielding: integral Pb (lead); panels and handling area lined with PMMA (methyl methacrylate).
• Shielding thickness: 50 mm Pb.
• PMMA lining thickness: 15 mm.
• Overall dimensions (L×D×H): 2700 × 910 × 2220 mm.
• Total weight: 4,500 kg.