KIRO® Oncology

Grifols KIRO Oncology is an aseptic compounding robotic system with engineering controls that focus on precision, flexibility, reliability, and safety throughout the highly complex process of compounding chemotherapy medications.

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Overview

For the compounding of sterile preparations of hazardous drugs.

Benefits of KIRO Oncology

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>, USP <800>, and Current Good Manufacturing Practice (cGMP) regulations on engineering controls for aseptic hazardous 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
  • Negative pressure and ACPH are adjustable within USP <800> 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
  • Easy to use web-based software application accessible from any workstation with automatic and manual compounding queues, reporting and more.

Staff Protection
  • Protects users and environment from exposure to hazardous drug during critical operations by functioning as a negative-pressure, closed system
  • Compounding area is only open for non-critical material loading and unloading operations, during which it operates as a Class II Biosafety Cabinet
  • Protects users from repetitive stress injuries by automating those that require the most force
  • Protects the user and environment from hazardous waste with integrated systems for automated disposal
  • Self-cleaning process avoids exposure to any potential hazardous drug residue and provides both disinfection and chemical decontamination

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 reduces time spent by staff

Download our product brochure for more information about features, regulation compliance and equipment specifications, installation requirements and certifications.

KIRO Oncology Brochure

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Need help with your sterile compounding plans?

Contact our experts to discuss your sterile compounding needs and future plans. Our team is here to support you.

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