Thermocycler Verifications

Quality Assurance
1

Hi All,

Curious as to how various individuals, labs, and companies verify their thermocyclers in regulated environments to meet the requirements of accreditation and licensing organizations.

For example, the Inheco ODTC is quite popular in the NGS Diagnostics industry and can be tested with its own verification tool, the OVT, which probes 8 wells and 2 points on the headed lid. For other instruments, there are the ATS devices

That said, New York State requirements states that each cavity of a thermocycler must be tested at certain intervals:

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To meet that requirement, one would need to move on to something like the TAS System with additional probes

So, I’m curious, how does your organization meet these requirements? I would love to hear from people’s experiences and best practices.

2

OVT satisfies option A.

We never had issues with NY using the OVT.

With that said audits are tricky and opinions can differ from auditor to auditor but technically the OVT is the manufacturers test kit.

Inheco may also have additional information about the OVT and how that satisfies their internal or external requirements (think of Quality docs for consumables that are sterile) and it would be nice to file those as an insurance policy.

1 Like
3

Hi Luis,

Thanks for your reply. Your interpretation is our interpretation and testing plan as well for the ODTCs, so I am glad that other have come to the same understanding and plan as us!

Still curious as to how others accomplish this.