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fast microbiology testing?
Has anybody used a microbiology testing handheld device in place of “real micro testing?” We had a vendor come by and suggested we could use this hand held machine/software and results would be done in 8 hours. Not sure exactly how its done but the idea seems far fetched. I am told this is commonly used in the food industry. I thought most micro testing normally can take 3-7 days to complete.
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14 Replies
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Following!!
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Was it the Charles River Endosafe handheld Limulus Amebocyte Lysate based detection system?
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i will have to check but I am a trying to find out is this something new that cosmetic industry is looking into? How accurate and safe in the long run.
I am not familiar with the limulus dectection system?
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In Industrial Pharmacy they use the LAL system quite often. It is also a cool backstory with a link to me locally. The Limulus Amebocyte reagents are obtained through the bleeding of Horse Shoe Crabs and the isolation/standardization of the proteins. The reagents react in the presence of microbial contamination. The company has a handheld system using slides. It has even been used on the International Space Station. Recently I visited a College roommate at his work, a Pharmaceutical Manufacturer and the LAL systems were ubiquitous throughout his facility.
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@Microformulation, The LAL test system is great for spotting endotoxins in general and is more or less mandatory in pharmaceutical research, unfortunately, it may have a negative impact on the horseshoe crabs as they are gathered bleed to death (or at least so close there is little chance for recovery) and the birds that feed on their spawn.
There are alternative testing methods, but I am unsure of whether they are approved and validated.
As for a testing device, I have no idea.
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Actually, if you look at the mortality rates of the bleeding crabs, it is very low, in fact below their natural mortality rate. Here in SC, the Pharmaceutical Industry lobbied to stop the use of Horseshoe crabs as bait. The Commercial Fishing Industry would kill far more crabs on a yearly basis by far than the Pharmaceutical Industry. In fact, the Horseshoe crab population is expanding here in the Carolina’s.I only know this because the facility is for ann intents and purposes in my neighborhood. It is less than 5 miles away and I have toured the Facility.
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Gentleman, I am trying to ascertain if this device would be something that would save us money in the long run or could be more of a liability in the future when something comes up bad and we don’t have proper testing done.
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French company BioMérieux has introduced rapid micro test system that can test micro test within two hours.LAL Test is generally for sterile products. -
I’m sure these systems work as advertised. The one caution I would have is that microbes naturally exhibit an exponential growth curve peaking at 48 to 72 hours. So, if you used these systems and tested daily over a 3 day period, with perhaps a security check at 7 days, you’re probably in good shape.
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@MarkBroussard reading your post does it mean you only bottle at day 7?
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No, what I am referring to is more this type of technology substituting for a full Preservative Challenge Screen or Preservative Challenge Test.
It’s all a function of your experience base with the particular formula is question. If it’s an established product that you have made many times without issue, then I would be somewhat comfortable with the 8 hour analysis. But, I will admit that I have not studied these systems in any type of detail, so I don’t know at what threshold level of reference compound is sufficient to claim a positive or negative test. I would presume that any detection of the reference compound in the batch is indicative of contamination.
I will also assume that the reference compound is a very specific indicator of microbial growth and is unique & specific enough that there could not be a possibility of a false positive.
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I am concerned are these going to be as good or better than “real” micro that can take 3-7 days to perform. this will be a cost savings but at what price just save a few dollars. Do these test do yeast and mold as well as TCP and enrichment?
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Another concern lies in that these test for endotoxins, and not all bacteria that may cause issues produce endotoxins. You can have relatively benign bacteria that preclude release due to high colony counts. Having no endotoxins does not make it “clean” or safe for use.
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This system adopted by govt. (india) to monitor public health.more details on link.
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