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BRC Clause 5.6.2.4 - analog incubator calibration

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Omoware

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Posted 27 January 2021 - 05:14 PM

Hi all, my company is new to BRC standard and the lab incubator has never been calibrated. I am trying to write a SOP for calibrating the incubator but the manufacturer said that it does not need to be calibrated because it is an analog incubator. Does anyone know if an analog incubator needs to be calibrated or not? Please see clause below:

 

Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.2.3. These shall include:

  • use of recognised test methods, where available
  • documented testing procedures
  • ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
  • use of a system to verify the accuracy of test results (e.g. ring or proficiency testing)
  • use of appropriately calibrated and maintained equipment.

 

Your input will be appreciated! Thanks!



Charles.C

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Posted 27 January 2021 - 05:21 PM

Hi all,

 

My company is new to BRC standard and the lab incubator has never been calibrated. I am trying to write a SOP for calibrating the incubator but the manufacturer said that it does not need to be calibrated because it is an analog incubator. Does anyone know if an analog incubator needs to be calibrated or not? Please see clause below:

 

Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.2.3. These shall include:

  • use of recognised test methods, where available
  • documented testing procedures
  • ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
  • use of a system to verify the accuracy of test results (e.g. ring or proficiency testing)
  • use of appropriately calibrated and maintained equipment.

 

Your input will be appreciated!

 

Thanks!

 

Someone is "having you on". :smile:


Kind Regards,

 

Charles.C


liberator

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Posted 02 February 2021 - 09:31 PM

Analog or digital, doesn't matter. If you're not checking the temperature of your incubator how do you know it's running at the right temperature for the micros you're testing for? Running too hot or too cold will impact the test and your micro results will be garbage.

 

You'll need multiple calibrated thermometers, or a thermometer and multiple thermocouples, which have all been checked against a calibrated reference standard thermometer.  Typically, 5 points in each shelf of an incubator are checked, all the corners or close to each corner and a central checkpoint per shelf (and if you have multiple shelves, all shelves).

Set your incubator to the temperature required for the test. Place the thermocouples/temp probes into the relevant locations in the incubator. With the thermometer displays or thermocouple plugs hanging outside the incubator. Shut the door. Let the incubator stabilise - a hour or 2. No one is to open the door. After the elapsed time check the temperatures across the five points. Check against the incubator set temp, record and then adjust according to the error on your calibrated instrument.

 

Repeat for the next set of shelves. If the incubator is fan forced you may have a more even temperature profile, if not then there may well be hot and cold spots within the incubator and across the shelves. You'll have to be aware of these and if they are outside of the range of the required incubation temperature (typically +/- 1°C you'll have to ensure those areas in the incubator are not used.

 

Do you log your daily incubator temperatures?


Edited by liberator, 02 February 2021 - 09:31 PM.


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Omoware

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Posted 04 February 2021 - 08:49 PM

Analog or digital, doesn't matter. If you're not checking the temperature of your incubator how do you know it's running at the right temperature for the micros you're testing for? Running too hot or too cold will impact the test and your micro results will be garbage.

 

You'll need multiple calibrated thermometers, or a thermometer and multiple thermocouples, which have all been checked against a calibrated reference standard thermometer.  Typically, 5 points in each shelf of an incubator are checked, all the corners or close to each corner and a central checkpoint per shelf (and if you have multiple shelves, all shelves).

Set your incubator to the temperature required for the test. Place the thermocouples/temp probes into the relevant locations in the incubator. With the thermometer displays or thermocouple plugs hanging outside the incubator. Shut the door. Let the incubator stabilise - a hour or 2. No one is to open the door. After the elapsed time check the temperatures across the five points. Check against the incubator set temp, record and then adjust according to the error on your calibrated instrument.

 

Repeat for the next set of shelves. If the incubator is fan forced you may have a more even temperature profile, if not then there may well be hot and cold spots within the incubator and across the shelves. You'll have to be aware of these and if they are outside of the range of the required incubation temperature (typically +/- 1°C you'll have to ensure those areas in the incubator are not used.

 

Do you log your daily incubator temperatures?

Thanks for this information!

We don't log daily incubator temperatures. Our incubators are already set to the temperature needed.We don't change it at all. We only do yeast & mold, coliform and SPC.

 

Thanks again!



liberator

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Posted 04 February 2021 - 09:59 PM

Happy to help - if you need any more assistance let me know. 

 

i would seriously consider a daily temperature log record and check of the incubator. I'm surprised it's not been picked up in an audit.

 

We have a chart on the front of our incubators and a thermometer probe placed centrally inside the incubator where the temperature has been confirmed to be OK part of the calibration check,  with the display outside the incubator. These are checked 1st thing in the morning to make sure the temps are where they should be and recorded on the chart.

 

Just because the temperatures are set is not a guarantee they are right. Someone could fiddle with the settings, the incubator could be faulty. There are lots of variables that can/could impact your set temperature which would then bring into question the validity of the results obtained from your tests.


Edited by liberator, 04 February 2021 - 10:00 PM.


Omoware

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Posted 09 February 2021 - 03:45 PM

Happy to help - if you need any more assistance let me know. 

 

i would seriously consider a daily temperature log record and check of the incubator. I'm surprised it's not been picked up in an audit.

 

We have a chart on the front of our incubators and a thermometer probe placed centrally inside the incubator where the temperature has been confirmed to be OK part of the calibration check,  with the display outside the incubator. These are checked 1st thing in the morning to make sure the temps are where they should be and recorded on the chart.

 

Just because the temperatures are set is not a guarantee they are right. Someone could fiddle with the settings, the incubator could be faulty. There are lots of variables that can/could impact your set temperature which would then bring into question the validity of the results obtained from your tests.

 

Hi Liberated,

I am so delighted with your detailed response. I am working on setting this up.

Thanks!
 



Omoware

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Posted 09 February 2021 - 03:46 PM

 

Happy to help - if you need any more assistance let me know. 

 

i would seriously consider a daily temperature log record and check of the incubator. I'm surprised it's not been picked up in an audit.

 

We have a chart on the front of our incubators and a thermometer probe placed centrally inside the incubator where the temperature has been confirmed to be OK part of the calibration check,  with the display outside the incubator. These are checked 1st thing in the morning to make sure the temps are where they should be and recorded on the chart.

 

Just because the temperatures are set is not a guarantee they are right. Someone could fiddle with the settings, the incubator could be faulty. There are lots of variables that can/could impact your set temperature which would then bring into question the validity of the results obtained from your tests.

 

Hi Liberated,

I am so delighted with your detailed response. I am working on setting this up.

Thanks!
 

 

 

Hi Liberated,

I am so delighted with your detailed response. I am working on setting this up.

Thanks!





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