Our Isolators meet safety, suitability and convenience in high active pharmaceuticals powder dispensing and sampling.
The Isolators, manufactured on request, are able to meet the different types of applications such as quality assurance, reactors loading and unloading, compounding and sterility test. Manufactured in agreement with the European Directives and EN 60204-1; EN 12100-1 / 2; ISO/FDIS 14644 – 7; ISO 10648-1; ISO 10648-2.
Strength, Safety and Ergonomics:
• Main chamber negative pressure.
• Double Hepa filter on exhaust air push-push type.
• Minimum 20 air changes.
• PLC controls with phases to reduce risk of wrong operator actions.
• Glove break alarmed with 0,7 m/s air barrier on flange.
• AISI 316L 3mm thickness for main chamber.
• Class 2/3 tightness as for ISO 10648.
• Auto tightness test.
• 0,5 microns roughness in internal chamber.
• Qualification of the unit in FAT, SAT, IQ/OQ.
Steril is able to customize the design of the isolator.
INTEGRATED DECONTAMINATION SYSTEM
• Integrated decontamination system VHP (Vapor Hydrogen Peroxyde)
• H2O2 consumption measured and reported.
• Overpressure released by dedicated discharge duct.
• PLC (Programmable Logical Control) for isolator and decontamination system
• PLC controls all process during all passages so to avoid any operator error
• Various operations can be settled on the display panel
• On the display panel are reported all alarms and messages with relevant data
...and much more!
Steril equipments, when Operator, Product and Environmental Protection is required!