By Michael Moedler and Hélène Pora
Collaboration between end users and suppliers on single-use technologies (SUTs) has increased tremendously in the past few years. Training, however, could benefit significantly from collaborative efforts between SUT suppliers and end users. Despite vendors’ extensive efforts to ensure the integrity of single-use systems and components during their assembly and packaging, damage leading to leakage can occur throughout the SUT life cycle, especially when bioprocess containers are handled improperly during shipment, interim storage, unpacking, installation, and ultimately operation.
To meet current good manufacturing practice (CGMP) requirements and ensure process quality, SUT operators must have high-quality training in handling, installing, and operating single-use production systems. Yet it has become increasingly difficult to provide such instruction. SUT adoption continues to grow as the biopharmaceutical market expands, and as many COVID-19 vaccines and other novel medicines move through phase 3 clinical trials to market approval, demand for well-trained SUT operators is growing faster than existing training infrastructures and methods can cope with.
SUT implementation requires a different skill set than that needed for traditional stainless-steel equipment: Operators must be trained on the unpacking, visual inspection, installation, inflation/leak testing, sterile connection, disconnection/disassembly, and disposal of contact items to prevent system/component damage and to minimize contaminations that can cause manufacturing failures.
In this paper we explore a combination of teaching methodologies that facilitates engaging and efficient training of SUT users of all skill levels.
BioProcess International Vol.20 (1-2)si January – February 2022