Robotics and Other Compounding Devices
Increase accuracy and control with automation that helps advance patient safety and protect staff during production of hazardous and non-hazardous compounded sterile preparations.
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
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
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
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
Gri-fill 3.0 Sterile CompoundingSystem 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
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.
Grifols is committed to providing you with the solutions you need. Please contact us for more information.