By Helene Pora, Ph.D. – Vice President Technical Communication & Regulatory Strategy, Pall Corporation
Gaps in employee and contractor training remain one of the top reasons that drug manufacturers fail cGMP compliance inspections by regulatory authorities. As the adoption of single-use technology (SUT) grows, effective training can achieve rapid SUT knowledge transfer to ensure successful and reliable operation in a cGMP-compliant process.
Single-use biocontainer (bag) breakage—from shipping or handling errors—is one of the top three reasons preventing more widespread use of SUT by biopharma manufacturers. Leakage of a single-use bag was reported by BioPhorum, a global collaboration of biopharmaceutical industry leaders and subject matter experts, to range anywhere from $50,000 to more than $20 million depending on the type of bag and the material it contains.
BioPhorum noted that improved training methods could considerably decrease the occurrence of leakage. However, SUT require a different skill set than traditional stainless-steel equipment. SUT operators must be trained on the unpacking, visual inspection, installation, inflation, sterile connection, disconnection/disassembly, and disposal of contact items to avoid damage that can lead to batch failures.
This article reviews how a blended training approach of face-to-face, e-learning, virtual classrooms, virtual and mixed reality training is the best way to achieve training goals.