Kill Step Validation - Laboratory
This forum is my "go to" place whenever I have a question or issue. I love this site as it is extremely helpful. That being said, I am in need of help.
We are planning on becoming SQF certified. SQF says that the labs we use must be ISO certified. We are planning on subcontracting out an in-house kill step validation. The contractor plans to spike the product with a surrogate (Enterococcus) and then analyze for the microbe before and after heat treatment to demonstrate a 5-log reduction. The lab they will use is their own, and is ISO certified. However, the certification does not include Enterococcus analysis. They say that the ISO 17025 scope only covers routine laboratory analysis and that there are not always standard methods for research so they cannot be ISO accredited against them.
Is the lack of ISO certification going to be an issue for the validity of the validation?
Thank you for your help!!
This forum is my "go to" place whenever I have a question or issue. I love this site as it is extremely helpful. That being said, I am in need of help.
We are planning on becoming SQF certified. SQF says that the labs we use must be ISO certified. We are planning on subcontracting out an in-house kill step validation. The contractor plans to spike the product with a surrogate (Enterococcus) and then analyze for the microbe before and after heat treatment to demonstrate a 5-log reduction. The lab they will use is their own, and is ISO certified. However, the certification does not include Enterococcus analysis. They say that the ISO 17025 scope only covers routine laboratory analysis and that there are not always standard methods for research so they cannot be ISO accredited against them.
Is the lack of ISO certification going to be an issue for the validity of the validation?
Thank you for your help!!
Hi clindsell,
^^^^(red) - I'm not an iso expert but as per the iso17025 standard it seems that lab. accreditation should have involved fulfilment of certain features associated with the laboratory's implemented test methods. Notably the lab should be using an appropriately pre-validated methodology or, if not, possess validatory documentation of their own method.
Details are elaborated in 5,1 - 5,3 (Pg 5) of attachment below -
accreditation for micro. labs.pdf 312.74KB 14 downloads
I agree with charles. the enterococcus method should be listed. the actual validation study would not.
huge deal? probably not. but your probably paying a ton of money, so it is a simple expectation
I agree with charles. the enterococcus method should be listed. the actual validation study would not.
huge deal? probably not. but your probably paying a ton of money, so it is a simple expectation
Just for example, AOAC approved microbial detection/estimation methods typically have (eg their journal) referenced validations.
Depending on the specific Process, Kill-Step Validation Procedures may not be "simple".
Thank you. You have both been very helpful.