Hi Shivani.
Let me start by quoting the absolute truism in RAPS - the answer to almost every question is going to start with "It depends".
The dependency here is what information you are looking to obtain from the data. So as an example, a test that is being performed for the purpose of providing data to assert that the product is acceptable for release might need more specific information than an ATP Bioluminescence or Luminescent bacterial test can provide. This is because these tests simply look for how much ATP or other biologically active compound is found in your sample but they don't tell you much about numbers or even types of organisms present, let alone genus or species.
On the other hand, if these tests are done for quick checks of the production environment they can be rather useful because the data are what I have always considered "semi-quantitative". This means that you can set parameters around how much is too much but that you don't necessarily need to know if the contaminant is Staphylococcus epidermidis or Salmonella typhimurium. The reason I consider these tests semi-quantitative is that the test itself is usually not able to provide an "absolute" number of organisms per sample but instead provides a relative measure. This relativity is a function of the fact that the amount of these biologically active compounds will be different based on the actual organism(s) present in your sampling and whether or not this is a homogenous or heterogeneous culture.
I could go on for days on this topic and I am happy to try to help further but in the interests of the rest of the forum's time and emails, I'll stop here. If you would like to connect, please let me know via an email and I will happily help out any way that I can!
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 14-Sep-2021 04:11
From: Shivani Chawda
Subject: Microbial testing
Dear All,
I have to clarify one point that in dental aligner manufacturing what all microbial testing we can do in order to keep the microbes in check. which test is beneficial?
Luminescent bacterial test
bio-burden testing or
ATP Bioluminescence assay?
or please mention if there is any other testing which are used in the Medical Device Industry ?
If anyone can also share the related document then it would be really grateful.
Thank you so much in advance.
Regards
Shivani
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Shivani Chawda
Quality Assurance Executive
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