Regulatory Open Forum

 View Only
  • 1.  ATP rapid testing

    Posted 29-Mar-2017 11:46
    Can I have get an educated opinion on the use of ATP rapid testing to replace traditional Micro testing for finished product release in the food industry .



  • 2.  RE: ATP rapid testing

    Posted 30-Mar-2017 08:36
    Hi Susan.

    As a microbiologist by prior life, I am not a big fan of ATP assays in general. The problem is that they are not in any way quantitative and more importantly they have no ability to tell you what organism is causing any response.  This is especially important in my mind in the food industry where you expect to have some level of counts but you have specific organisms in your HACCP plan and you FSMA review that you are generally going to consider unacceptable.  With ATP systems, you might be able to validate the system to some degree to be semi-quantitative (you would, in my opinion, need to run the test against known amounts of organisms) but even this would be ballpark at best since different organisms are likely to produce different levels of ATP per CFU.  The bigger problem is that you will still need to do some sort of presence/absence test for the particular objectionable organisms in your plan.  This is simply because ATP is ATP whether it comes from human fingers, the filamentous fungi Aspergillus brasiliensis, the yeast Candida albicans, the gram positive bacillus Bacillus thuringensis, the enteric Escherichia coli, or the non-fermenting gram positive Burkholderia cepacia.  Note that some of these are likely objectionable to your client's process while others are not...so you need to know not just how many but just as importantly which organism(s) you are dealing with.

    ------------------------------
    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
    ------------------------------