Saboraud's Agar Incubation Temperature and Validation Requirements

[Chithra86]

Hi, i would like to know, currently we are incubating our SDA plates, at 25 +/- 2, which is not as per ISO recommendation. Do i need to change the incubation temperature, and if yes, do i have to do a validation for this?

 

[somashekar]

Re: S.D.A Incubation

Welcome to the COVE Chithra ~~~
Yes you have to validate again with the temperatures and time suggested per the ISO standard that you refer to. Also consult with your SDA manufacturer for his recommendation.

 

[Ajit Basrur]

Re: Question on use of Saboraud's Agar incubation temperature

Hi, i would like to know, currently we are incubating our SDA plates, at 25 +/- 2, which is not as per ISO recommendation. Do i need to change the incubation temperature, and if yes, do i have to do a validation for this?

Firstly, welcome

I am not sure on how you decided to have an incubation temperature of 25 +/- 2 when the Pharmacopeial requirement is 20 - 25 deg C ?

 

[Chithra86]

Re: Question on use of Saboraud's Agar incubation temperature

Hi, thank you for the warm welcome.

This is my new company, and when i was going through the SOP, I came across this, that the incubation is set at 25 +/- 2, AND I knw that this need to be changed, but i was not very sure if a validation was required.

 

[Ajit Basrur]

Re: Question on use of Saboraud's Agar incubation temperature

Hi, thank you for the warm welcome.

This is my new company, and when i was going through the SOP, I came across this, that the incubation is set at 25 +/- 2, AND I knw that this need to be changed, but i was not very sure if a validation was required.

Could you tell more about what is the article being tested ?

 

[Chithra86]

This is for bio burden and environmental monitoring. I am working in a surgical glove manufacturing company.

 

[Ajit Basrur]

This is for bio burden and environmental monitoring. I am working in a surgical glove manufacturing company.

In that case, I would strongly advice to use the USP limits of 20 - 25 deg C for incubation and not attempting to use another temperature limit.

 

[Chithra86]

Thank you, do i have to perform a validation for that, or i just can change the SOP accordingly and provide the justification.

 

[Ajit Basrur]

Pharmacopeial methods are considered validated and you can give the reference of the Pharmacopeia (if you are in US, that would be USP).

You should also initiate a Change Control and do a small study to compare the result obtained on the same sample by incubating at the higher incubation temp and this new Pharmacopeal requirement.

When you perform this study and get compareable results, that would not negate or invalidate the past results on which you would released batches.

 

[Chithra86]

Thank you very much sir for your information, its truly appreciated.

Thank you