17 Days

Standard + Add-On

Improve Quality of Cleanroom Staff Training

3 People

2.877 (as of January, 2023)

Cornerstone LMS

The customer is a research-driven, specialty biopharmaceutical group. It is is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. As a sterile manufacturer, the customer must comply with EU GMP and other global compliance rules and meet the highest sterility standards.

An important aspect of contamination control is training the employees who handle the products. The customer has been using various training methods such as text, pictures, videos, and practical courses over the years. However, these methods were not yielding the desired results. The theoretical materials were not the most effective, with a low recall rate. As a result, the customer experimented with “multimodal training modes,” including practical sessions using blacklight and special powder to make fingerprints and contamination visible, or training procedures at partially fitted cabinets. The goal of this type of training is to provide trainees with a realistic environment to practice and learn through doing, rather than simply teaching them. While training in a complete cleanroom environment would provide the best training effect, it is often unfeasible due to its high cost, subjectivity, intensive oversight requirements, and limited capacity for trainees. In conclusion, it became apparent that a new mode of training was needed to achieve better success.

After learning about virtual reality training and Innerspace from other sterile manufacturers during a training exchange, the customers Manager of HR Systems & GMP Training, contacted Innerspace and initiated the project. The Quality Assurance Manager at the customer gave the green light after the first online demo meeting, and the project was presented internally to the QA/QC and Production Teams. Innerspace was then invited to conduct a two-day demo workshop that included presentations and hands-on experience with the VR Simulator. The project was deemed successful, and the contract was signed.

The project was carried out in two phases. During the first phase, which lasted around two months, the customer conceptualized and planned the project. They established a training room, defined the content, training groups, and training intervals, and aligned the concept with production areas and company events. The customer also selected trainers who would execute the project and decided to make VR training mandatory.

The second installation phase was shorter, taking only 17 days. Innerspace remotely installed the VR Simulator Stations, reducing cost and eliminating the need for an onsite visit. The customer’s employees began a two-week testing period, and trainers were onboarded through an onsite “Train the Trainer Workshop” that lasted six hours. Once everything was set up and everyone was familiar with the VR Simulator, the new training track went live, and the Innerspace Virtual Reality Simulator became an established training tool for the customer.

The customer decided to create different training paths, with mandatory or optional modules for different employee groups, as part of their VR training program. Six distinct employee groups were identified, with the largest and highest-risk groups being “Operator Production” (90 employees), “Mediafill & PS/QA” (30), and “Operator Micro” (20). These groups received the most extensive training, with almost all modules being mandatory. The external cleaning company (16 employees) also received extensive training in cleanroom movement and disinfection. TPS employees (9) and visitors received the least amount of mandatory training, covering only glove disinfection, body movement, and hand hygiene.

Aside from the fixed training blocks for different employee groups, training blocks were also made available for employees with a more flexible schedule. Each training session took one hour and was conducted on a 1:1 basis. A total of eight trainers provided VR training, with a capacity of 30 employees per week.

Later on, the customer decided to integrate the training data into their Learning Management System (LMS) via Cornerstone. This allowed for detailed training data to be documented for each individual trainee. The integration made documentation easier, more explicit, and more time-efficient than before. With this system in place, it was easier for trainees to distinguish between mandatory and voluntary modules and keep track of their training curriculum, as well as for the trainers to monitor training progress. For the future, an extensive expansion of the success measurements and error tracking system is planned by Innerspace. This will further increase training effectiveness by identifying individual weak spots in depth and improving on them.

Between August 2020 and January 2023, around 300 employees trained with the VR-Simulator. Overall, 2,877 training sessions have been completed, with an average session length of around 35 minutes and a completion rate of nearly 90%.

The feedback on the new training track was very positive. Participants reported that the VR-Simulator training was enjoyable, felt realistic, and that the perceived effectiveness of the training was higher than standard methods. Many participants highlighted that having objective measurements like movement speed helped them understand the limits and develop a natural feeling for the correct procedure. It was also highly useful for experienced operators, who reported that the objective measurements and instant feedback were eye-opening and helped them improve their subconscious routines. Unlike other “simulation methods” such as training in cleanroom environments as a group, the individual one-on-one training with the VR Simulator provided a blame-free and safe training space that encourages self-reflection and learning from mistakes. In total, the clear rules and measures to assess performance and correct mistakes, combined with the possibility to repeat crucial steps in a “non-risk realistic environment,” were a game changer.

The Training Simulator also resonated with younger trainees, who saw it as modern and a benefit when looking for a new employer. They also found it very helpful in the onboarding process because they could “train on the job,” and the visualization and interaction with invisible elements like laminar airflow, germs, or contamination areas fostered understanding.