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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-10-11
- Length: 32m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/106---Temperature-Mapping--Validation--Data-Loggers--Cold-Chain--Monitoring-and-Commissioning-with-Nathan-Roman-e2aahcj

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=0) Introduction: Nathan Roman and Career Transition from CAD to Validation
- [6:53](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=413) Evolution of Temperature Mapping: Wired Thermocouples to Wireless Data Loggers
- [12:32](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=752) Temperature Mapping vs. Monitoring: Cold Chain, Warm Products, and Regulatory Requirements
- [17:48](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=1068) Temperature Mapping as Standalone Study vs. Subset of Equipment Qualification
- [22:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=1336) The Shift from Separate C, Q, and V to Integrated CQV Processes
- [26:44](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-11-106-temperature-mapping-validation-data-loggers-cold-chain-monitoring-and-commis#t=1604) Cold Chain Challenges: LN2 Vapor Phase, Cryo Storage, and Shipping Validation

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Logistics & fulfilment](https://hardwarepodcasts.com/topic/logistics-and-fulfillment)
- [PCB design & layout](https://hardwarepodcasts.com/topic/pcb-design)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- Neat (tool)
- USP (other)
- ISPE (other)
- LinkedIn (other)

## Related episodes from other shows

- [Implementing an eQMS after Switching from Paper](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper) (Global Medical Device Podcast)
- [#370: Meet a Guru: Jamie Bihary](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-30-370-meet-a-guru-jamie-bihary) (Global Medical Device Podcast)
- [Building End-to-End Supply Chain Visibility | Roambee's Sanjay Sharma | Internet of Things Podcast](https://hardwarepodcasts.com/podcast/iot-for-all-podcast/2022-09-27-building-end-to-end-supply-chain-visibility-roambees-sanjay-sharma-internet-of-t) (IoT For All Podcast)

## Citing this page

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