Sterility Fails Alice-TFC

5byfive

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These were tagged ok to share. I know most of us filter so its not the end of the world but part of a larger pattern of QC issues that we are seeing. They ran endo on a couple of these and they came back low.

Test Report #96024.webpTest Report #106573.webpTest Report #96027.webpTest Report #106577.webp
 
Interesting that those tests were done in December and February and the results are just now coming out?
They are 3P tests, your lucky to ever see them if you where not a paying member of the testing group.

I was in a group buy and all TFC T30,40,60 and R30 failed sterility during the same time period. Numbers weren't very bad.
Sterility isn't guaranteed, I believe in a couple instances a slight discount was given and some were refunded prior to final shipment.
 
They are 3P tests, your lucky to ever see them if you where not a paying member of the testing group.

I was in a group buy and all TFC T30,40,60 and R30 failed sterility during the same time period. Numbers weren't very bad.
Sterility isn't guaranteed, I believe in a couple instances a slight discount was given and some were refunded prior to final shipment.

I am aware of how 3p test groups work, however if there is something potentially harmful found, they will usually vote to release to the public as a safety precaution.
 
Additional, more-recent test results were just shared on TG as a community notice. While none individually would be too alarming, the overall trend with this supplier seems to indicate some broader QC issues.

Shared with permission from the group that commissioned the test and shared the notice:




Edit to clarify the COAs show undisclosed but according to the owner, they are Alice TFC.
 
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Endotoxins came out simply as ">10 EU/vial", so we don't really know what the level is, and Janoshik estimates are random numbers.
 
Endotoxins came out simply as ">10 EU/vial", so we don't really know what the level is, and Janoshik estimates are random numbers.
Correct. I think this has been covered pretty well in all of the recent posts, but it never hurts to repeat it for the benefit of folks who will stumble upon this later after the other posts have died down.
 
The linked Janoshik report indicates ~25.1 EU/vial.

View attachment 20724
This is an estimate, and historically has been widely inaccurate, like I said before. You should absolutely not rely on it. The only thing we know for sure is that levels are > 10. Another test with a validated assay in the 10-1000 range will be needed to find the true levels.
 
This is an estimate, and historically has been widely inaccurate, like I said before. You should absolutely not rely on it. The only thing we know for sure is that levels are > 10. Another test with a validated assay in the 10-1000 range will be needed to find the true levels.
Yes, absolutely right! I had a NAD+ which was in the first test estimated 26 by Jano and came out in the second test with 625 EU!!!
 
Yes, absolutely right! I had a NAD+ which was in the first test estimated 26 by Jano and came out in the second test with 625 EU!!!
625 at a time would not be great, but when a vial is for something like 20+ doses, its pretty far below what even the FDA considers harmful, right?

5 EU/kg (2.2lb) body weight per hour is the FDA standard. If you weigh ~80 kg (176lb) thats roughly 400 EU per injection/dose.

I get it that ZERO endo is best, but when we're stating these numbers its per vial and the amounts sometimes barely exceed what the FDA states could cause fever with a single injection.
 
625 at a time would not be great, but when a vial is for something like 20+ doses, its pretty far below what even the FDA considers harmful, right?

5 EU/kg (2.2lb) body weight per hour is the FDA standard. If you weigh ~80 kg (176lb) thats roughly 400 EU per injection/dose.

I get it that ZERO endo is best, but when we're stating these numbers its per vial and the amounts sometimes barely exceed what the FDA states could cause fever with a single injection.
Yes it is 1000mg and divided by 40 or even 20 is ok for me.
 
I am aware of how 3p test groups work, however if there is something potentially harmful found, they will usually vote to release to the public as a safety precaution.
I think the dilemma there is that most of the time failed sterility isn't a significant risk factor. As such if a group shares it publicly, the average response will be something like "so what" or "that's why I always filter...blah blah." They'll be left wondering why they even bothered to share.

But I think if it starts to become a pattern with a certain vendor and/or source (as was the case here), it could imply broader things about a certain facility's finishing process that the broader community might be curious about. Sort of like how if a friend comes down with a cold, you'll wish them well but not think of it as being out of the ordinary. But if that same friend comes down with their 6th cold in 5 months, you might be motivated to dig in a little deeper there and express concern.

Wont endos increase while in the vail?
What's your rationale for thinking that?
 
What's your rationale for thinking that?
I believe (I am not the op on that, just speculation) the theory would be that since bacteria release endotoxins, that endo count would rise as the bacteria grows.
However, I believe that depends on the type of bacteria found. Endotoxins or only released by gram negative bacteria.
Many groups don't test for the type of bacteria after failed sterility, so it would be unknown (in this case) unless they test.
 
I believe (I am not the op on that, just speculation) the theory would be that since bacteria release endotoxins, that endo count would rise as the bacteria grows.
An excellent reason to use BAC water and/or filter and I suspect most are already doing at least one or the other here.
 
An excellent reason to use BAC water and/or filter and I suspect most are already doing at least one or the other here.
Always, however studies have found that even in BAC, some bacteria (like staph) are still quite aggressive when refrigerated.
This is one of the reasons why its important to ID the specific bacteria.
 
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My thought is bacteria reproduce over time. But I don’t know how this works. And I have absolutely no clue how bac would affect endos.
 
There is no effect of BAC on endos. They are dead gram negative walls of cells, typically e. Coli. They won't grow because they are dead. BAC prevents the growth of living organisms that may be in a vial after lyophilizing. They can be filtered out, endos can't be without specialized filters.
 
My thought is bacteria reproduce over time. But I don’t know how this works. And I have absolutely no clue how bac would affect endos.
Rabbit poop doesn't create more rabbit poop. Only rabbits do that. If you filter out rabbits (put a fence around your garden) it doesn't matter how many rabbits visited your garden before the fence went up. You're not going to get more rabbit poop showing up in your garden. Similarly, if you lay out poison for the rabbits instead, you're less likely to get a family of rabbits taking up residence in your garden and pooping like crazy there, unless you get unlucky and it's a breed of rabbit that isn't affected by that poison.

Before putting up fences or laying poison, it's possible that you might see some old rabbit poop that's laying in the garden from last season. If you see new rabbits in spring you might be tempted to conclude that they're the rabbits that laid that old poop, but that's unlikely to be true, since winter/predators/nature will have likely killed whatever rabbits laid that poop last year and it's most likely entirely new rabbits you're looking at now. But if you don't put that fence up or lay poison, those new rabbits could obviously add on to whatever poop remains there from last year.
 
Wont endos increase while in the vail?
Endos will not increase before you reconstitute the peptide. Bacteria can't grow in lyophilized powder becuse there is no water. If a batch is not sterile and you reconstitute it without filtering, you may get more endotoxins, but at that point, the bacteria will be the bigger issue.
 
I recently got a T30 from a vendor that failed sterility. I have filters but no hospira bac water (used it up last week 😭 ). I have bac water from a US reseller which in my opinion is good ---- do you guys recommend I wait til the hospira arrives next week? Or it's okay to use the US vendor's bac? Please say the latter. Please say the latter... 🥹
 
I recently got a T30 from a vendor that failed sterility. I have filters but no hospira bac water (used it up last week 😭 ). I have bac water from a US reseller which in my opinion is good ---- do you guys recommend I wait til the hospira arrives next week? Or it's okay to use the US vendor's bac? Please say the latter. Please say the latter... 🥹
Check out the reviews from these guys I just make my own now. I believe that solution came from Colorado.
 

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