Compounding area

  • Two robotic arms.
  • 12-port carousel for the vials in use.
  • Preparation bay for up to 8 infusion bags, cassettes, or elastomeric pumps.
  • Syringe holder for up to 8 syringes.
  • Syringe capping station with 4 capping positions.
  • Holding area for up to 10 partially used vials.
  • Gravimetric device for in-process weighing.
  • Two peristaltic pumps for diluent filling and reconstitution.
  • Two cameras for syringe and vial identification, respectively.
  • Barcode reader for product identification.
  • A touchpad for loading validation parameters.
compounding_area

Supported materials

  • Vials: All vial sizes from 0.5 to 100 mL.
  • Syringes: Luer lock syringes (1, 3, 10, 20, & 50 mL).
  • Final containers: Infusion bags, syringes, elastomeric pumps, & cassettes.
supportedmaterials

Installation requirements

  • KIRO® Oncology dimensions (W x D x H): 6.9 ft x 3.7 ft x 7.3 ft. / 2100 mm x 1072 mm x 2235 mm.
  • Minimum clearance: 3.5 ft (front) x 2 ft (right) x 1 ft (left) x 1 ft (back). / 100 cm (front) x 60 cm (right) x 30 cm (left) x 30 cm (back).
  • Weight: 2660 lb (1200 kg).
  • Area floor load rating ≥ 133Ib/ft2 (650Kg/m2).
  • Exhaust duct: 0,66 ft diameter < 21,000 cubic feet/hour.
  • Power: 120VAC ± 10%, 60Hz, 3kVA, 25A or 230 VAC ± 10%, 50Hz, 3kVA, 13A).
  • RJ45 Ethernet port.
installation

User interface area

  • User touchscreen interface.
  • Gravimetric device to double check weighing.
  • Barcode reader for product identification.
  • Two label printers (bags and syringes).
kiro_screen

Air treatment area

  • ISO 5 compounding area.
  • Environmental protection by HEPA exhaust filter and negative pressure in recirculation chamber.
  • User protection by enclosed compounding environment under negative pressure.
filtro

Waste area

  • Two waste disposal units.
  • Two additional Bag-In Bag-Out filters for air cleaning before recirculation.
wastearea

Implementation plan

  • Preinstallation assessment.
  • Delivery, assembly and startup.
  • Device qualification: Installation, integration, operation and performance qualification.
  • Development of enviromental monitoring program.
  • Personnel training and qualification.
implementation

More about KIRO Oncology

  • Pharmacy Compounding Device listed in FDA databases as a Class II device under 21 CFR 880.5440, Product Code NEP. FDA Device Listing Number D244880.
  • UL certified for compliance per:
    • IEC 61010-1:2010 Third Edition, Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
    • EN 61326-1:2006  Electrical equipment for measurement, control and laboratory use.  EMC requirements.  Part 1:  General requirements
  • UL Listing File number E468972.
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