18 & 21 Days per Site

Standard + Add-On

Improve quality of production, reduce production downtime, harmonize training methods, establish holistic training cycle for all production employees, individualize training based on process analysis

7 People;
3 of Innerspace
4 of Fresenius Kabi

2.082 (as of September 04, 2023)

LMS connection scheduled (as of June 2023)

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Their products and services are used for the therapy and care of critically and chronically ill patients. As a manufacturer of sterile products, Fresenius Kabi must comply with EU GMP and other global compliance rules and meet the highest standards to achieve sterility.

Fresenius Kabi recognized the substantial potential in new learning techniques and technological advancements and how they could be used to address the challenges of aseptic manufacturing in a more efficient way. Their overall goal was to enhance training effectiveness and improve aseptic technique understanding. The company also aimed to adjust their training in advance to the revised Annex 1 (August 2023) training requirements.

Another goal was to harmonize training methods, to ensure consistency and standardize training curriculums. Starting at the site level, the potential outlook was to harmonize training across applicable aseptic manufacturing sites. The company also aimed to implement a comprehensive training cycle that encompassed operators and employees that need to have a good aseptic understanding. This cycle would include initial training, ongoing skill development, and targeted remediation to address specific weaknesses. Recognizing that each employee may have unique learning needs, Fresenius Kabi intended to tailor training programs based on job requirements, ensuring that each team member received the necessary training and support to excel in their role.

Fresenius Kabi partnered with Innerspace to implement virtual reality technology into their operator training program. The open-minded, learner-focused approach of Fresenius Kabi’s management drove this project significantly. The customer adjusted their internal planning, recognizing VR Training as an emerging “standard of training” that they aim to pioneer within the industry. They allocated a dedicated budget for implementing innovative changes. A key advocate was Alexander Stoll, Vice President and Head of the Competence Center for Microbiology & Aseptic Technique. He recognized the early potential of the VR Training Simulator and championed its adoption.

The project began with the Melrose Park site and has since extended to Grand Island. It started with integrating VR Simulator Training into standard SOPs and three running licenses for both sites. The implementation involved the integration of the VR Simulator into existing training programs, with a particular focus on creating a holistic training approach and integrate new Annex 1 changes. Regular check-ins between Innerspace’s Customer Service Managers and Fresenius Kabi’s training program managers occurred every six weeks and allowed for a quick and responsive adaption. This close cooperation facilitated the quick integration of VR training into standard operating procedures and drove the success of the project.

At the Grand Island facility, Innerspace’s Chief Methodologist, Sebastian Scheler, led a Success Measurement Workshop in June 2023, as a proof of concept for the Innerspace methodology. During this workshop, a comprehensive gap analysis was conducted, pinpointing weaknesses in both processes and training methodologies. The findings from this analysis served as the cornerstone for several strategic improvements, including the development of an enhanced training curriculum. Furthermore, Standard Operating Procedures (SOPs) were thoroughly reworked to align with a principle-based approach rather than a process-based one, ensuring a more profound understanding of the underlying principles driving operations. This holistic approach leveraged the strengths of VR Simulators to their full potential.

Innerspace provided Fresenius Kabi with Virtual Reality Cleanroom Simulators that allow trainees to experience a realistic cleanroom environment virtually. The simulators enabled trainees to practice aseptic techniques, understand principles and raise awareness through visualization of invisible processes, and receive immediate feedback on their performance.

The VR Simulator Training package provided by Innerspace comprised the technical product (Simulator Stations), Premium Support, and the Simulator Module License. This package encompassed a range of standard simulator modules that train correct behavior and awareness in cleanroom environments. These modules included topics such as Disinfection of Surfaces, Correct Body and Hand Movements, Navigating Critical Areas, as well as add-on modules focusing on complex skills and interventions in fill-finish and laboratory environments. These advanced modules covered activities like Exchange of Settle Plates, Principles of First Air for RABS, Environmental Monitoring and others.

Initially commencing with a single license and a limited module selection, the Grand Island site effectively expanded their contract during the first renewal date after the first year of adoption. This expansion involved adding more modules, securing an additional license, and incorporating E-Documentation via LMS into the agreement. Furthermore, they are beta testing a new Locks and Gowning Module.

The implementation of virtual reality simulators had several positive outcomes for Fresenius Kabi that were highlighted by their staff in the frequent check-ins. The simulators provided a quick and accessible way for trainees to immerse themselves in a cleanroom environment. This allowed for increased training success and knowledge retention, reducing the need for re-training sessions and, consequently, preventing interruptions in production schedules.

With the VR Simulators significant emphasis on training that prioritized increasing awareness through the imparting of background knowledge, hands-on practice, demonstration, and instant feedback, the trainees gained the ability to comprehend the underlying principles behind their actions and recognize the resulting outcomes. Consequently, they were able to adapt their behavior proactively and preemptively prevent errors by relying on genuine understanding, rather than merely replicating procedures or memorizing processes. This facilitated a better understanding of aseptic techniques and reduced the risk of errors in critical grade A interventions improving trainees’ confidence.

The simulators also offered objectivity in evaluating trainees’ performance, providing transparent and reproducible feedback. The scheduled connection of E-Documentation and the Learning Management System with the VR Training will allow for progress tracing over time, unlocking the full potential of the technology. The continuous feedback loop enabled by the simulators in combination with the Success Measurement Workshop and the gap-analysis helped address the challenges posed by reduced opportunities for behavioral feedback in the new isolator manufacturing technologies. Overall, a holistic training cycle has been established, including the new training curriculum that fully utilizes the strengths of VR Simulator Training. Together with the adapted SOPs, the goal of harmonizing training methods was reached.