Need a non-validated word

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

I am working on SOPs for a non-validated process. We are steaming the equipment. We claim the equipment is “steamed” because we are not validating sterility during SIP. We use a Temperature Crayon as a secondary check of the temperature of the vessel, lines and fittings during steaming. The check ensures that the vessel, line or fitting is at 121C.

I need a verb that says we used the crayon to verify or confirm the target temperature was achieved. One of my reviewers says “verify” and “confirm” both imply a validated state. Please suggest a word (or wording) that connotes a positive affirmation of the temperature without implying validation. The target sentence is, “Use a Temperature Crayon to ________ 121C at the steam trap.”

Thanks wordsmiths,
Tom B

2

Hi Tom

what about
’use the temperature crayon to check that the temperature at the steam trap reaches 121 Deg C’…

regards

Niamh

3

How about “…give reasonable assurance that…”?

I would not agree that “confirm” implies validation but it’s probably not a battle worth fighting.

4

I would use “verify”. In the GHTF process validation guidance for medical devices it divides the two words “verify” and “validate” as two separate and distinct options, where “verification” is defined as 100% checking. Along these same lines, verifying can be used to take a measurement, such as what you are intending.

Also, if you clearly state that you are not validating the system, what is the harm in using either of those two words? An auditor might be “tricked” into thinking you have validated the system? Of course not, because you have explicitly stated it elsewhere. This reviewer wouldn’t be from QA would they?..

5

[quote=Brian81]I would use “verify”. In the GHTF process validation guidance for medical devices it divides the two words “verify” and “validate” as two separate and distinct options, where “verification” is defined as 100% checking. Along these same lines, verifying can be used to take a measurement, such as what you are intending.

Also, if you clearly state that you are not validating the system, what is the harm in using either of those two words? An auditor might be “tricked” into thinking you have validated the system? Of course not, because you have explicitly stated it elsewhere. This reviewer wouldn’t be from QA would they?..[/quote]

The target sentence is, “Use a Temperature Crayon to ensure 121C at the steam trap.”