Hardware Podcasts

106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman

Let's Combinate · 11 Oct 2023 · 32m

What this episode covers

Nathan Roman, a validation and temperature mapping expert with over 23 years of experience, explains the evolution of environmental validation in the life sciences industry. He details the shift from bulky wired thermocouples to wireless data loggers and paperless systems like Neat, which streamline protocol execution and documentation. Roman distinguishes between temperature mapping as a standalone study versus its role within broader equipment qualification (IQ/OQ/PQ), noting that modern CQV practices combine commissioning and qualification to reduce redundant testing. He also covers specific challenges in maintaining cold chain integrity, including the use of liquid nitrogen vapor phase storage and real-time monitoring during shipping validation.

Most relevant to

established companies

Topics

Mentioned

Tools
Neat
Also
USP, ISPE, LinkedIn

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