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Exploring the Current State of Robotic Sterile Compounding – Part 1

By Leigh Miley posted 05-14-2025 09:02

  

Exploring the Current State of Robotic Sterile Compounding – Part 1 

Authors: Stacy Carson, PharmD, BCPS, FISMP; Darren S Ferer, BS Pharm, CPHIMS; James Fiebert, PharmD, CPHIMS; Leigh Ann Miley, PharmD, BCPS, BCSCP; Destiny Riddle, PharmD; Audrey Ruotolo, PharmD, BCPS; Christopher Urbanski, BS Pharm, MS, FASHP 

SAG: Operations and Automation

Intro  

 Advancements in intravenous workflow management systems (IVWMS) have transformed the preparation of sterile compounds. IVWMS such as automated parenteral nutrition compounders, barcode scanning, gravimetric measuring systems, product libraries, image capture, and sterile compounding devices have improved accuracy, efficiency, and safety in sterile compounding preparation. Sterile compounding robotic devices incorporate multiple features of IVWMS and robotics, automating the process of sterile product compounding.1 Despite this, adoption of sterile compounding robots in hospitals has  declined, dropping from 4.3% in 2020 to 3.7% in 2023, with 2.9% for nonhazardous and 1.4% for hazardous preparations, primarily in hospitals with more than 50 staffed beds.2 Sterile compounding robotics can be a beneficial component in pharmacy operations for enhancing both patient and staff safety while streamlining workflows.3 In this post we’ll explore the available sterile compounding robotic solutions on the market, weigh the benefits and challenges of their implementation, share strategies for a successful integration into pharmacy workflows, and provide expert insights from solution owners. 

 

Overview of Available Solutions 

 Robotic sterile compounding devices first hit the pharmacy automation world with the release of the IntelliFill i.v. syringe robot from ForHealth Technologies, Inc., in 2001.4  Soon after, devices employing true-robotic arms similar to those used in manufacturing that could compound syringes and IV bags began hitting the market.4 Today there are upwards of half a dozen IV robotic compounding devices in various sizes that have been implemented for both hazardous and non-hazardous product compounding.  

Some of the main features marketed by the various device vendors include patient safety (barcode readers, cameras, gravimetric verification), regulatory compliance for USP <797> and USP <800>, cGMP compliance with ISO 5 compounding areas, staff safety (negative-pressure closed system preventing exposure to pharmacy staff), efficiency (self-cleaning and remote verification), and convenience (bidirectional interfaces, web-based software application).5-10  

Examples of available manufacturers include, but are not limited to:   

  • Non-Hazardous: ARxIUM RIVA, Baxter IntelliFill i.v., Omnicell i.v. Station, Grifols KIRO SP2, Apoteca Unit10 

  • Hazardous: Omnicell i.v. Station Onco, Loccioni Apoteca Chemo, ARxIUM RIVA, Equashield Pro, Grifols KIRO Oncology2

Benefits and Challenges of Implementation 

There are many benefits that can be seen with the use of sterile compounding robotic devicesSome of these benefits include enhanced safety, supply chain stabilization, and cost reduction.   These devices can improve both patient and employee safetyPatient safety improvements are seen through reduction in preparation errors A reduced risk of accidents and occupational exposure help improve employee safety.11 Another major benefit is supply chain stabilization, as many health systems use 503B outsourcing for medications which have had both quality issues and shipping delaysThe use of sterile compounding robotics can help ensure the availability of these items by preparing them in-house.12  Cost savings with sterile compounding robotic devices can be recognized in two main areasFirst, by preventing medication errors, there is the potential to decrease healthcare costsSecond, there are material savings costs with using the robot.13   

While there are many potential benefits to using sterile compounding robotic devices there are also several challengesSome of these challenges include upfront cost, time investment, and workflow changesWhile there is the potential for cost savings, it can take many years to break even.13  In addition, there is a significant initial time investment during implementation  Lastly, large scale workflow changes may be needed in order to ensure the robot meets the needs of the organization.14     

When considering sterile compounding robotic devices it is important to understand best practices around their implementation and use.15  ISMP has released a set of best practices that include: completion of a failure mode and effects analysis (FMEA), development of an overarching technology infrastructure, use of human factors engineering principles, completion of preventative maintenance, assessment of staff competency, and regular event review.  Prior to implementation of sterile compounding robotic devices, an FMEA with appropriate stakeholders should be performed.  This will help ensure that proper safeguards are implemented to prevent unintended consequences and improve overall reliability. Development of an overarching technology infrastructure will help ensure that new products are properly added to all technology systems and ensures that all systems are updated prior to useNew workflows should be designed using human factors engineering principles to help reduce the potential for human error Regularly scheduled preventative maintenance will reduce potential downtime and ensure medication safety benefits are optimized Staff competency should be assessed at a minimum with initial training and then annually Close call compounding events should be reviewed at least quarterly to help with error analysis and process improvement 

 

Strategies for Success  

Several strategies can help to ensure success when rolling out new robotics for sterile compounding. One of the most important, noted by sites leveraging these technologies, is to plan early for the change management process, understanding that workflows will be impacted by the new technology. To effectively manage change, it’s first important to ensure executive buy-in. This underpins both the financial investment required for both the initial robotics implementation,16 as well as the leadership structure which will be needed to set expectations for performance and utilization. A leadership executive who champions the project will smooth the way as buy-in spreads throughout the organization.17  

Additional recommendations include defining the staffing model for the robot. Strategies here vary among organizations, with some sites recommending dedicated staff to decrease the number of staff needed to train. This additionally frees up resources to engage in other activities.17 Conversely, some sites recommend cross-training all staff. This carries the benefit of ensuring that staff are always available to operate the robot, maximizing its output and the return on the financial investment for the technology.18  

Finally, implementation of a sterile compounding robot presents both the opportunity to standardize compounding practices and the challenges of doing so. Utilizing standard concentrations ensures easily repeatable workflows, which helps to maximize efficiency for the technology by decreasing interruptions due to the need to swap products and processes when switching from one preparation type to another.  

Once the initial adoption phase is complete, organizations may wish to seek further success by optimizing their production with the compounding robot. Both robot output and staff utilization can be increased with purposeful choice of medications which can be smoothly prepared by the machine.17 In the same vein, anticipating the robot’s needs will help to ensure that it operates smoothly and efficiently, with as little downtime as possible. This can be accomplished by performing reconstitutions in advance, ensuring that compounding items are well-stocked, and that staff coverage during breaks is provided. Finally, medication information changes must be proactively managed. Thorough integration testing of new medication items is recommended to ensure that they perform as desired.18 These strategies can help to ensure success in implementation of compounding robot technologies, supporting maximization of investment and staff adoption.  

 

Conclusion  

 Over the past two decades, adoption of  automated workflow technologies in healthcare institution pharmacies for sterile compounding has increased.1,19-21  This came about after several significant patient safety events and the realization that there was a void in manual sterile compounding oversight.22-23  Like many other technologies used in health-system pharmacy, we must keep in mind that these are tools that need to be used as intended and monitored to address potential workarounds.  Teams need to be deeply involved in the testing, maintenance, support and training of such technologies to ensure that they are accurate and being used properlySuch teams should also ensure that these systems are kept current with downtime processes in place for when that need arises.15 This blog only scratches the surface on the current state of robotics in sterile compoundingFor additional information on this subject please consult the many resources available from ASHP, ISMP and others in this blossoming field. 

For more information on real-world experiences in utilizing sterile compounding robotics, see part two of this blog where Angela Yaniv, PharmD, BCSCP shares how Cleveland Clinic has leveraged this technology.  

References

  1. Nichols T. IV workflow management systems: A century in the making. pharmacypracticenews.com. June 22, 2023. Accessed March 12, 2025. https://www.pharmacypracticenews.com/Review-Articles/Article/06-23/IV-Workflow-Management-Systems-A-Century-in-the-Making/70493?ses=ogst. 

  1. Schneider PJ, Pedersen CA, Ganio MC, Scheckelhoff DJ. ASHP National Survey of Pharmacy Practice in Hospital Settings: Operations and Technology — 2023. Am J Health-Sys Pharm. 2024;81(16):684-705. 

  1. Boyd AM, Chaffee BW. Critical Evaluation of Pharmacy Automation and Robotic Systems: A Call to Action. Hosp Pharm. 2019;54(1):4-11. 

  1. Osborne JA. IntelliFill i.v. European Society of Hospital Pharmaceutical Technologies website. Accessed: March 25, 2025. https://www.gerpac.eu/intellifill-i-v-1889 

  1. Grifols. Compounding Automation. Grifols inclusiv website.  https://www.grifolsinclusiv.com/en/compounding-automation/automation, Accessed March 3, 2025. 

  1. Omnicell. IVX Station. Omnicell website. https://www.omnicell.com/iv-room/ivx-station/. Accessed March 3, 2025. 

  1. ARxium. Robotic IV Automation. ARxium website. https://www.arxium.com/robotic-iv-automation. Accessed March 3, 2025. 

  1. Equashield. Automated Compounding of Hazardous Drugs. Equashield website. https://www.equashield.com/products/equashield-pro/. Accessed March 3, 2025.  

  1. Equashield. Mundus HD Mini: The Future of Automated Compounding of Hazardous Drugs. Equashield website. https://www.equashield.com/products/mundus-mini-hd/. Accessed March 3, 2025. 

  1. Apoteca Loccioni. Apoteca. Apoteca Loccioni website. https://www.loccioni.com/en/apoteca/ Accessed May 6, 2025. 

  1. Yang C, Ni X, Zhang L, Peng L. Intravenous compounding robots in pharmacy intravenous admixture services: A systematic review. Medicine (Baltimore). 2023 May 12;102(19):e33476. 

  1. Hansen KN, Freudiger MJ. Case 5 Compounded Sterile Preparations Using Automation – Robotics. In: Granko RP. Financial Management for Health-System Pharmacists. 2nd ed. American Society of Health-System Pharmacists; 2022:211-224. 

  1. Bhakta SB, Colavecchia AC, Coffey W, Curlee DR, Garey KW. Implementation and evaluation of a sterile compounding robot in a satellite oncology pharmacy. Am J Health Syst Pharm. 2018 Jun 1;75(11 Supplement 2):S51-S57. 

  1. Irvine C, Soefje S. Enhance Chemo Delivery with IV Robot Workflows. Pharmacy Purchasing & Products Magazine. pppmag.com.  2023 May;20(5):2. Accessed February 5, 2025. https://www.pppmag.com/article/3090 

  1. ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology. Institute for Safe Medication Practices. 2022. 

  1. Bronstein D. 5 Ways to a Successful Robotics Rollout. Pharmacypracticenews.com. September 17, 2022. Accessed February 4, 2025. 

  1. Sykes B. Maximize Production with IV Compounding Robots. Pharmacy Purchasing & Products Magazine. pppmag.com. 2018 May;15(5):26. Accessed February 4, 2025. https://www.pppmag.com/article/2224 

  1. Yaniv A, Knoer S. Implementation of an I.V.-compounding robot in a hospital-based cancer center pharmacy. Am J Health-Sys Pharm. 2013;70(22):2030-2037. 

  1. Pedersen CA, Schneider PJ, Douglas J. Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2005. Amer J Health-Sys Pharm. 2006;63(4):327-345. 

  1. Pedersen CA, Schneider PJ, Douglas J. Scheckelhoff DJ. ASHP National Survey of Pharmacy Practice in Hospital Settings: Dispensing and Administration—2008. Amer J Health-Sys Pharm. 2009;66(10): 877. 

  1. Pedersen CA, Schneider PJ, Douglas J. Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2011. Am J Health-Sys Pharm. 2012;69(9):768–785. 

  1. Myers CE. History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past. Am J Health-Sys Pharm. 2013;70(16):1414–1427. 

  1. Pew Charitable Trusts. U.S. illnesses and deaths associated with compounded medications (2001-2013). www.pewtrusts.org/en/research-and-analysis/analysis/2013/09/06/us-illnesses-and-deaths-associated-with-compounded-medications Accessed March 21, 2025. 

 

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