Grifols KIRO Oncology Automated Compounding Device

KIRO Oncology

For the compounding of sterile preparations of hazardous drugs.

KIRO SP

For the compounding of sterile preparations of non-hazardous drugs.
 

  • Visibility and greater control of accuracy via gravimetrics, barcode readers, and cameras
  • Flexible design: syringes, IV bags, cassettes, and elastomeric pumps
  • Enclosed, self-cleaning for staff protection
  • Improved efficiency via innovative software and hardware
  • EMR interface and multi-device integration

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

Benefits of Grifols KIRO Oncology

Patient Safety

  • Precision scales perform gravimetric verification at all stages of the compounding process for assurance of dose accuracy
  • In-process barcode readers and cameras capture data on drugs, disposables, and final containers with or without barcodes for accurate traceability
  • Accuracy is calculated for automatic error rejection and reporting
  • Beyond use dates (BUDs) are automatically calculated and tracked for final products and multi-dose vials to ensure maximum fluid removal, automatic disposal, and waste minimization

Staff Protection

  • Self-cleaning process mitigates exposure to hazardous drugs and chemicals
  • The cabinet is only opened for loading and unloading, protecting operators from repetitive stress injuries and exposure to hazardous drugs
  • Automated compounding and self-cleaning occur in a completely enclosed environment offering unparalleled protection for staff
 

Regulatory Compliance

  • ISO 5 compounding area meets USP <797> standards and relevant Good Manufacturing Processes (GMPs) for patient safety
  • Designed to meet <USP 800> standards for operator and environment protection from unintended exposure to hazardous drugs during loading and unloading.
  • Searchable, reportable database automatically captures valuable data

Efficiency

  • Two robotic arms enable vial reconstitution and bag filling in parallel
  • High-precision drug and diluent pumps maximize reliability of dosing success
  • Accommodation of a variety of sizes and manufacturers' bags, syringes, infusers, and cassettes—as well as industry-standard disposables—mitigates disruption to current contracts and preferences
  • Prepares patient-specific doses and small batches using liquid and lyophilized drugs
  • Partially used vials are held within the cabinet and can be automatically used for subsequent dose preparation
  • Partial-vial labels, database tracking, and intelligent alerts maximize reuse of unloaded partial vials
  • Design optimizes workflow efficiencies and minimizes risks of repetitive task injuries
  • Integrated system for secure disposal of hazardous waste without compromising the cabinet or cleanroom environment
 

Ease

  • Interface engine supports bidirectional messaging with many protocols, including HL7
  • Size—equivalent to a 6-foot vertical flow cabinet—facilitates integration into existing cleanroom facilities

 

KIRO SP is a KIRO Oncology robot used for the automated production of compounded sterile preparations of nonhazardous doses. It is particularly well-suited for specialized and/or complex dose preparations requiring an exceptionally high degree of accuracy.

 

Benefits of Grifols KIRO SP

Patient Safety

  • Barcode scanning for reduced risk of human error
  • A linear camera for visual control of labels
  • Batch and expiration date control for safety
  • Double gravimetric control helps to ensure accuracy
  • Reports on database records

Staff Safety

  • Compounding in an enclosed environment
  • Self-cleaning
  • Automated waste disposal
 

Operational Benefits

  • Manages partially used vials
  • Accommodates various sizes and manufacturers of vials and syringes
  • Two coordinated robotic arms for higher speed during complex preparations
  • Two peristaltic pumps enable fast, accurate dosing of diluents
  • Robust and intuitive user interface
  • Order selection (manual or automated)
  • Patient-specific (patient view)
  • Standard dose (product view)
  • Label printing with customizable templates
  • Partial vial management (internal and external)
  • Media fill cycles
  • Self-cleaning
  • Vision system
  • Technical assistance
Grifols KIRO Fill

KIRO® Fill Automated Compounding Device

  • High throughput syringe filling of non-hazardous sterile preparations
  • Automation of key critical and repetitive processes such as capping and filling to ensure consistency
  • Unique design allows loading, unloading, and compounding to occur simultaneously
  • Small footprint comparable to a standard six foot laminar flow hood

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KIRO Fill is an automated compounding device designed to enhance dosing accuracy and optimize operational efficiencies during the production of non-hazardous compounded sterile preparations.

Benefits of KIRO Fill

Patient Safety

  • ISO 5 aseptic compounding environment protects sterility during production of non-hazardous compounded sterile preparations
  • Automation minimizes risk of contamination and increases dosing accuracy
  • Touchscreen guided manual loading and unloading of supplies designed to avoid errors

Staff Protection

  • Automated filling reduces the risk of repetitive stress injuries
  • Automatic capping with tamper evident caps helps mitigate potential needle stick injuries
 

Control and Traceability

  • Loading and automated compounding processes are controlled by means of barcode scanning and RFID identification
  • Batch reports are automatically generated to ensure traceability through production, including environmental monitoring data

Flexibility and Efficiency

  • Unique design integrates two automated units working in parallel to facilitate high throughput (100-150 syringes per hour) to improve efficiency and optimize workflow
  • Up to 20 loading positions for syringes (including 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 60mL)
  • Small footprint preserves valuable cleanroom space
  • Optimizes use of medication and management of excess
 

Regulatory Compliance

  • Compliance with USP and GMP regulations supported by standardizing aseptic procedures, facilitating personnel and process qualification
  • Continuous air flow, temperature, and particle monitoring to meet GMP requirements
  • Fully serviced during deployment, qualification, and periodic maintenance, including dosing accuracy tests and air flow certifications addressing smoke tests under dynamic conditions for USP <797> compliance
  • KIRO Fill meets electrical safety requirements by being UL listing marked per IEC 61010 and EMC certified per IEC 61326-1
Grifols Gri-fill device for automatic IV compounding

Gri-fill 3.0 Sterile Compounding
System and Gri-bag

Advance patient safety and mitigate repetitive stress injuries with precision and sterility assurance.

Gri-fill® 3.0

  • Prepares batches and patient-specific doses
  • Accommodates syringes, IV bags, vials, bottles, cassettes, and infusers
  • Precise dosing with volumetric pump
  • Compact footprint

Gri-Bag

  • Sterile, disposable bags in multiple sizes
  • Sterilizing filter and integrity test for confirmation of sterility integral to each bag
Grifols Gri-fill device for automatic IV compounding

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Gri-fill 3.0 is designed to advance efficiencies and quality during the compounding of any type of intravenous mixture (including chemotherapy).

Gri-fill 3.0 is compact, easy to install, and easily adaptable to the workflow of intravenous mixtures compounding.

Benefits of Gri-fill 3.0

Patient Safety

  • Sterility assurance using Gri-Bag®
  • Precise dosing with volumetric pump
  • Reduced risk of microbial contamination
  • Lot traceability and expiration control
  • In-process checks and validation

User Safety

  • Avoids repetitive strain injuries
  • Reduced risk of occupational exposure
  • Needle-free
 

Efficient, Flexible, and Easy to Use

  • Automatic filling and drug reconstitution
  • Fits comfortably inside a standard laminar airflow hood or biosafety cabinet, without hindering its proper functioning
  • Simple connection to sets and containers
  • Easy to clean
  • Adaptable to different source solution containers (vials, bags, bottles) and to different final containers (Gri-Bag, bags, syringes, elastomeric pumps, cassettes, etc.)

Gri-Bag

The Gri-fill system, when used in conjunction with Gri-Bag, passes each drug dose through a 0.2 μm filter incorporated in the bag and performs an integrity test on each unit after dosing. Thus, Gri-fill ensures that sterility is maintained throughout the compounding process.

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