4 replies to this topic

[arahman]

Hello,

 

I have been assigned to complete validation study for a 53 foot reefer truck with a installation qualification, operational qualification and performance qualification for summer and winter studies.

 

Unfortunately, I have zero background in this which my director knows and she has asked me to do a bare bone validation at least for the first study.

 

I was hoping someone would be able to help me out with guidance or examples of validation studies performed in the past if possible.

I assumed a validation consultant with appropriate educational background and certification would need to complete it and apparently the company had previously hired consultants where the cost of astronomical and study written up too complicated and no study had been done for the past 5 years. 

 

I am not sure how to proceed with the actual protocols to validate a 53 foot reefer truck for transportation of products in 2-8deg C and 15-30 deg c

 

Moderators, I didn't know which forum this should fall under so just chose calibration but it should probably be under a new forum altogether. 

 

Thank you all in advance

[Brendan Triplett]

arahman,

 

We have temperature sensors on every truck that give us life temperatures and temperature recording for every route while the engine is running.  We temp every truck before it is loaded and we have them calibrated by an outside agency once per year.  Of course we maintain documentation for these so that we can pass them along in audits.  We have yet to have an FDA complaint about it.

 

Cheers!

[FSQA]

I am not sure how to proceed with the actual protocols to validate a 53 foot reefer truck for transportation of products in 2-8deg C and 15-30 deg c

 

Is the trailer divided into two compartments?

 

Just as a starter , if you are going to validate it by yourself, you will require temperature monitoring at regular intervals (or continuous) in this reefer, with the ability to record time and temperature.

It could be done Live (as mentioned in the previous post) or could be done intermittently (at the end of the day). However, whatever time is recorded for your validation study, corresponding outside temperatures should also be noted, as it can help you once you are completing your validation.

 

Also check the Cold chain alliance resource, as they have good information of temp controls during trans:

https://www.gcca.org/

[arahman]

Thank you for the responses! Appreciate it.

What the validation consultant suggested for the Performance Qualification:

Test 1: expose 2-8 °C compartment to ambient warehouse condition. check how long it take for out of spec(oos) condition to be reached. close door and test how long it takes for temp to go back to range

Test 2: Expose 2-8 °C /15-25°C compartment to external weather condition during summer/winter. check how long it take for oos condition to be reached. close door and test how long it takes for temp to go back to range

Test 3: Reefer failure and recovery during summer/winter conditions for 2-8 °C /15-25°C. check how long it take for oos condition to be reached. close door and test how long it takes for temp to go back to range

Test 4: Thermal verification at optimal set point(based on Operational qualification) during summer/winter conditions for 2-8 °C /15-25°C. check how long it take for oos condition to be reached. close door and test how long it takes for temp to go back to range(live load/simulated load). study will be continue on for min. 4 days/96 hours.

 

They came up with the scenarios based on risk assessments.

I suggested carrying out the test with simulated static loads(no 'live' scheduled loads)

Edited by arahman, 02 March 2020 - 08:31 PM.

[arahman]

Is the trailer divided into two compartments? Yes.

 

Just as a starter , if you are going to validate it by yourself, you will require temperature monitoring at regular intervals (or continuous) in this reefer, with the ability to record time and temperature.

It could be done Live (as mentioned in the previous post) or could be done intermittently (at the end of the day). However, whatever time is recorded for your validation study, corresponding outside temperatures should also be noted, as it can help you once you are completing your validation.

 

hoping to get this done with a simulated static load in our truck yard.

 

Also check the Cold chain alliance resource, as they have good information of temp controls during trans:

https://www.gcca.org/

 

thank you for the link.