In an industry that is averse to change, learning how to optimize and leverage traditional technologies with new-school technologies has played a critical role in widening the skills gap.
New technologies change the game
The biopharmaceutical industry is being moved forward by innovations in technology that are helping to streamline processes and achieve new heights. Single-use technologies (SUT) have been one of the greatest enablers of the industry by far over the past decade. However, in an industry that is averse to change, learning how to optimize and leverage traditional technologies with new-school technologies has played a critical role in widening the skills gap.
With SUT now available for a broad range of applications, including large volume cell cultivation, tank holding, and various downstream purification systems, we see an evolution toward complete single-source SUT manufacturing trains up to 2000 L working volume. Along with these new manufacturing trains, there are also all the required tubing sets and biocontainer assemblies. But it is not just full SUT assemblies that are driving the industry. Hybrid approaches are also available, integrating different types of technologies to achieve bioprocessing success. And the drive towards continuous bioprocessing is creating a paradigm shift in the industry towards working smarter via automation and data collection and analysis.
All these new approaches to processing have increased the responsibility of the suppliers with regards to providing robust designs and high-quality manufacturing of single-use systems (SUS). On the user side, SUS require various stages of handling and operator interactions, which makes comprehensive current good manufacturing practice (cGMP) focused training programs critical to ensuring that the advances are optimized. Efficient personnel training strategies and collaborative relationships between suppliers and manufacturers can be developed that take into consideration human learning aptitude and ensure efficacious transfer of skills to personnel. The idea is to have lasting impact beyond just complying with regulatory documentation requirements.
Design-based solutions
Suppliers like Cytiva have realized the fundamental responsibility to mitigate additional challenges for manufacturers and have implemented this in product design. At Cytiva, we continuously improve our design of existing and new systems by engaging a deep understanding of the wants and needs of the end users; this approach is commonly referred to as User Centered Design (UCD).
The International Usability Standard, ISO 13407, specifies the principles and activities of UCD processes, as follows:
- The design is based upon an explicit understanding of users, tasks, and environments.
- Users are involved throughout design and development.
- The design is driven and refined by user-centered evaluation.
- The process is iterative.
- The design addresses the whole user experience.
- The design team includes multidisciplinary skills and perspectives.
The goal is to clearly comprehend the end user experience and pain points and deliver design solutions that overcome them. Methods such as Poka-Yoke, e.g., ‘mistake-proofing’ with colors, number coding, and labeling can help make equipment more intuitive. However, labeling must always be kept minimal and concise.
Training-based solutions
Regardless of design, training is a critical part cGMP compliance and ultimate success in bioprocesses. Like design, training should be user focused and easy to learn, understand, and apply.
A mix of practical exercises, demonstrations and videos can help with this, with the goal of creating strong recall for the actual application of the methods. To assist in the recollection of the training, quick Instructions for Use (IFU) can provide an executive summary of the training the user received. This can be even more beneficial if the quick IFU can be referred to when using the product (as an instruction label or embedded with the Human Machine Interface [HMI]).
Technology-based training for success
Now more than ever, we see technology playing an irreplaceable role in leading companies into the next generation of bioprocessing. Cytiva has made large investments of time and money to optimize technology and deliver products, services, and training systems that support customer goals.