KIRO® SP

Grifols KIRO SP is a KIRO Oncology robotic system used for the automated production of compounded sterile preparations of nonhazardous doses.

Benefits of Grifols KIRO SP

Patient Safety

  • ISO 5 or better air quality even when opened for cleaning
  • In-process barcode readers and cameras capture product and expiration data on drugs, disposables, and final containers with or without barcodes for verification, accurate traceability, and reduced risk of human error
  • Precision scales perform gravimetric verification at all stages of the compounding process for assurance of dose precision and reporting
  • Avoids cross-contamination by never reusing a disposable for different drugs across different order
  • Adjustable parameters for automatic release of precisely dosed preparations
  • Beyond use dates (BUDs) are automatically assigned and tracked for final products and also for multi-dose vials to ensure maximum utilization, automatic disposal, and waste minimization
  • Tracking, rejection, and final labels can be customized to each facility’s needs

Regulatory Compliance

  • ISO 5 compounding area meets USP <797> and Current Good Manufacturing Practice (cGMP) regulations on engineering controls for aseptic compounding
  • Designed as a containment primary engineering control, provides continuous ISO 5 environment during materials loading and automatic compounding
  • Can be properly integrated as a biosafety cabinet in USP <797> and cGMP compliant facilities
  • No turbulence or refluxing at any critical site
  • Sterile products and preparations are not exposed to room air once loaded
  • All processes can be performed without introducing contamination
  • ACPH adjustable within USP <797> requirements
  • Included “media fill test cycle” simulates complex preparation for user and device requalifications
  • Searchable, reportable database automatically captures valuable data including ingredient NDC, lot and expiration, precise actual dosing amount, waste and precision relative to order, production time points, user interactions, and BUDs

Ease

  • Interface engine supports bidirectional integration with EMR by a variety of protocols including HL7
  • Size — equivalent to a 6-foot vertical flow cabinet — facilitates integration into existing cleanroom facilities
  • Robust and intuitive user interface
  • Automatic or manual selection of patient specific orders and anticipatory standard preparations
  • 24/7 Customer service and fast onsite technician response

Staff Protection

  • Protects users from repetitive stress injuries by automating tasks that require the most force or reaching.

Efficiency

  • Two robotic arms enable multiple parallel processes for speed and efficiency
  • Two peristaltic pumps enable fast, precise dosing of diluents
  • Accommodation of a variety of sizes and manufacturers' bags, syringes, infusers, and cassettes—as well as industry-standard disposables — mitigates disruption to current and future contracts and preferences
  • Prepares patient-specific doses and small batches using liquid and lyophilized drugs • Partial vials are held within the cabinet and can be automatically used for subsequent dose preparation
  • “Partial vial” labels, database tracking, and recommendations to use available partial vials maximize reuse of unloaded partial vials
  • Automatic disposal of empty vials and used disposables
  • Optimizes workflow efficiencies by freeing user to start picking process for next order or other tasks
  • Self-cleaning process cleans and disinfects the compounding area, reducing time spent by staff

Learn more about Robotics and Other Compounding Devices

Contact our experts to discuss your sterile compounding needs and plans for the future.