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Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
Both suppliers and users of single-use technologies (SUTs) recognize the need for more efficient and effective training to support the handling and use of SUTs to ensure the biopharmaceutical workforce can successfully and reliably operate good manufacturing practice (GMP)-compliant, aseptic, SUT-based bioprocesses. Establishing adequate training solutions has become increasingly imperative as SUT use at the commercial scale accelerates.
In an article in Pharmaceutical Technology, “Addressing the Training Gap for Single-Use Technologies”(1), the authors discussed reasons for the SUT training gap and why SUT training is crucial to biopharmaceutical manufacturing. This follow-up article outlines the fundamental aspects of training and adult learning styles, elucidates the value of digital and virtual learning, and explains the approach adopted by Pall and Lonza in a collaboration intended to address the SUT training gap.
The first project involved the joint development of a training program for tangential-flow filtration (TFF); additional training modules are planned to follow. Leveraging Lonza’s understanding of the fundamental aspects of training and adult learning styles and Pall’s knowledge of SUT handling and operations of the specific TFF equipment, this novel approach combines digital tools and virtual reality solutions with in-person and hands-on training sessions.
The goal of any training program is to get everyone who receives the training to execute the same tasks in the same manner and in the same timeframe, leading to the same output every time. To achieve that essential goal for product quality and patient safety, it is essential to identify training needs and address them holistically. In essence, training must support transfer of knowledge as well as skills and behaviors required for consistent high-level performance (see Figure 1).
Adult learning styles must also be considered. There are generally four ways to learn: listening (auditory), viewing (visual), reading/writing, and doing (hands-on). These learning styles can be addressed with either passive or participatory teaching methods. The former includes lectures, reading, audiovisual tools, and demonstrations, while the latter comprise group discussions, practice, and teaching others.
Adult learners are focused on learning what they need to be successful in their current role, and therefore want to learn about the things they need to know to reach assigned goals and objectives. Some of the best practices for adult learning, therefore, include face-to-face interactions and participatory programs that require problem-solving, are topic-centered, and involve real-life scenarios linked to actual daily tasks so that everyone remains interested and engaged.
Each of these different learning methods has unique benefits and advantages/disadvantages. According to the National Training Laboratories, retention of learning content ranges from 5–30% for passive methods and 50–90% for participatory methods (2). Inaddition, adults often learn as much from committing errors (trying and failing), because they must think about what went wrong and why, which leads to greater understanding of the process and prevents reoccurrence.
Training on SUTs requires addressing the specific training needs for SUTs while keeping in mind adult learning preferences and the different needs to ensure essential transfer of knowledge, skills, and attitude, including understanding of overall process implications caused by potential variations in the individual tasks.
The design of efficient training programs focused on the handling and use of SUTs must be accomplished by applying the best learning and training methodologies while understanding the specific requirements when operating SUTs. The programs must be suitable for employees with limited or no experience in biopharmaceutical manufacturing, be largely self-directed, be available in several languages, include instructions on the rules and procedures for maintaining aseptic conditions, and take into consideration the fact that access to actual, installed single-use systems and cleanroom suites is limited.
To be competent with SUTs, operators must be not only provided knowledge about the do’s and don’ts of proper handling, but also understand and be able to apply that way of operating consistently; they must exhibit a special attitude when working with SUTs. Training must be provided on the skills and behaviors necessary to touch and handle SUT materials, maintain awareness about the environment, and perform specific tasks reliably.
In addition, effective SUT training goes beyond meeting compliance requirements; it ensures that operators can perform the jobs competently under real-life conditions. Typically, however, access to commercial-scale equipment, particularly equipment located in a cleanroom setting, is severely limited for training purposes. Conditions within a cleanroom may also be limited with respect to training needs (i.e., number of people allowed, ability to bring in training materials during commercial production). Trainer resources may also be limited.
When the needs and available methods are considered, it can be concluded that face-to-face training, e-learning, virtual classrooms, virtual reality training, and mixed reality training represent the best options.
Face-to-face training provides the opportunity for intense, hands-on experiences, while e-learning with enhanced interactive videos and checklists (including assessments) provide a level of active and participatory learning. Virtual classrooms combine group discussions with some listening and watching, and virtual reality and mixed reality training simulate real-life activities with muscle memory and are expected to enable new operators and lab personal to learn operating procedures much faster—anywhere at any time.
Leveraging existing digital training methods already in place at Pall, the two companies developed a proprietary training platform consisting of a series of online training tools specifically covering SUT use, handling, and operations. The initial focus was to create a tool for classifying defects in biocontainers, thus enabling better identification of defects and more systematic trending for systematic learning, which would better prevent bag breakage. A library of defects was developed, along with a training package that includes videos and checklists that can be incorporated into standard operating procedures. Operators are trained to differentiate between cosmetic and actual defects as well as what might be the potential causes for each.
While virtual reality (VR) training might seem like science fiction or gaming, it is advanced and increasingly used in various manufacturing and other settings, including training surgeons, helicopter pilots, and astronauts. The biopharmaceutical industry is already using this approach in several areas (3). Takeda, for example, employs VR to train operators on aseptic practices (4). Leveraging proven digital technology such as VR and augmented reality or mixed reality (MR) for SUT training can decrease the training time of new operators and increase training efficacy. In addition, such training can reduce training costs, eliminate the trainer-time bottleneck, increase the productivity of new hires, and enable on-demand retraining of employees without additional expense. By providing better, more engaging training, training effectiveness can be improved, leading to decreased human errors and therefore increased reliability of supply.
Learning how to move and perform proper cleaning in a cleanroom is a priority module because it applies to all GMP production sites. Operators in a virtual cleanroom can train on aseptic practices (e.g., movement speed, placement of objects, correct cleaning procedures) and establish muscle memory to improve quality and decrease the risk of contamination.
Lonza provided the information to establish a virtual suite with an exact, fully interactable replica of the equipment to be used in production. Employees can train in this virtual, safe environment at their individual learning pace on how to handle and use the equipment, even before a production line is installed. Furthermore, they can also jointly perform and discuss in the same VR room with colleagues and trainers located at other sites around the world without traveling.
VR training is preceded by virtual classrooms to establish a basic understanding of the equipment and process to be learned using VR/MR. Additional requirements, such as watching videos, reading assignments, online assessments, and paper analyses, together with the virtual classrooms ensure that all trainees begin the VR/MR portion of the training with the same level of understanding.
The virtual cleanroom has been outfitted with equipment such as pipettes and biosafety cabinets (BSCs) so users can experience sterile pipette assembly and realistic cleaning and movement techniques. VR technology enhancements like haptic gloves allow higher immersion.
A beta version for selected basic standard unit operations in cleanrooms and BSCs was piloted mid-2020. Goals of the VR training program include 25% reduction in human-caused errors compared to traditional training and a 20% decrease in training time.
Collaboration led to the development of training modules with shop floor relevance that are helping to reduce the time required for operator training while resulting in operators that are better trained. Working jointly in one direction resulted in a win-win situation for all involved.
In the current environment where SUT adoption is accelerating, the biopharmaceutical industry is expanding rapidly, manufacturing paradigms are continuing to evolve, and new hires are entering the workforce at an unprecedented rate, manufacturers must respond quickly to ensure that training programs are compliant to enable accelerated learning for competence.
Collaboration between SUT suppliers and end users, meanwhile, helps shorten timelines for training program development while also enhancing program quality. It also enables the development of comprehensive training portfolios comprising a wide range of training tools so that training solutions can be matched to the specific needs of trainees and the intended goals.
A combination of different personal and digital training methods affords practically helpful training solutions that, based on operator feedback, are more engaging and useful. Digital technology is a strong enabler for accelerating the deployment and enhancing the efficiency of SUT training when combined appropriately with hands-on training.
Michael Moedler, PhD, is head of Training at Lonza Biologics Operations Visp, and Helene Pora, PhD, is vice-president of Technical Communication and Regulatory Strategy at Pall Corporation.
Vol. 46, No. 2
Pages: 30–31, 48
When referring to this article, please cite it as M. Moedler and H. Pora, “Accelerating Workforce Training on Single-Use Technologies,” Pharmaceutical Technology 46 (2) 2022.