Article | September 1, 2021

Addressing The Training Gap For Single-Use Technologies

Source: Pall

By Helene Pora, Ph.D. – Vice President Technical Communication & Regulatory Strategy, Pall Corporation

Clinicians doctors meeting iStock-1264556832

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.

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