Nuclear medicine isolator ISO5-PET-NM

for radioisotope preparationfor radiopharmacysynthesis

ISO5.PET.MN is a pharmaceutical-grade shielded laminar-flow isolator designed for Nuclear Medicine and PET applications. It provides an ISO 5 manipulation area with dedicated shielding, filtration and control systems for the synthesis and fractionation of radiopharmaceuticals.

Key features

• Fully constructed in AISI 316L pharmaceutical-grade stainless steel
• PMMA front shielding
• Lead (Pb) shielding
• Main ISO 5 manipulation area to accommodate a synthesis module or fractionator; suitable for radiopharmaceutical handling and synthesis
• FL filtration system with absolute HEPA and ULPA filters
• Lateral pass-through with automatic sliding shelf for introduction and removal of vials, preparations, materials and small tools; internal door opens automatically; operation via touch panel or external foot pedal
• Underbench compartments for a dose calibrator chamber, accommodation of 2/4 Tc-99m generators and waste area
• Pneumatic opening/closing doors with interlock safety system
• Pre-chamber filtration with absolute HEPA H14 filters
• Internal LED illumination and UV lamp
• Sealed passages for technical gases and cable routing
• Internal power outlets
• LED signal column with visual and audible alarm
• Front PMMA airtight opening with pneumatic gasket, flanges and gloves
• External front wall in shielded stainless steel, manually openable with interlock; shielded pass-through portholes and anti-X viewing window
• Integrated internal radiation detector with external control unit
• Siemens touch control panel; pressure gauges for direct reading of operating pressures
• Integrated particle counter and management software to continuously monitor ISO class according to GMP and FDA requirements
• Compliant with GMP, GLP, GAMP, NBP, CFR21 guidelines
• IQ/OQ validations included

Accessories

• Dose calibrator
• Fractionator
• Synthesis module

Particularities and example model

• The illustrative SOPRA model is built with 50 mm Pb shielding and 20 mm PMMA
• Overall dimensions (L×D×H): 2210 × 1050 × 2250 mm
• Total weight: approximately 6000 kg
• Automatic dose fractionator positioned on the worktop (example integration)