Mochizuki0124
New member
Is anyone familiar with these labs and their testing? I've seen some groups that started using them.
Sterigenix and MZ Biolabs
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shirasu893
New member
I just received from SteriGenix a COA for their "Extended Panel" on the R60 sample I sent. That panel includes M/P, identity confirmation, Endos, Sterility, and Heavy Metals, which at $350 seemed to me like an incredible bargain. But I have no basis for concluding how accurate or inaccurate their reported results are. They received the sample on July 27 and sent me a link to the completed COA on August 4.
I was confused by the sterility result they reported, which was "Bacterial Growth (Accelerator): No Growth." That was good to hear, but August 4 was only only 8 days after the sample was received, and the description of their Extended Panel states that the sterility assay is USP <71> (14-day membrane filtration). So I sent them a question about this apparent discrepancy. I haven't heard back yet.
I had earlier asked SteriGenix how they performed their endotoxin assay. Jano requires a new sample if the initial assay is out of range and the customer desires a result more accurate than Jano's estimate of the out-of-range EU/vial value. SteriGenix replied that they perform successive dilutions with the original sample until the assay falls within the current run's accuracy range, which seems to me like the correct approach.
I was confused by the sterility result they reported, which was "Bacterial Growth (Accelerator): No Growth." That was good to hear, but August 4 was only only 8 days after the sample was received, and the description of their Extended Panel states that the sterility assay is USP <71> (14-day membrane filtration). So I sent them a question about this apparent discrepancy. I haven't heard back yet.
I had earlier asked SteriGenix how they performed their endotoxin assay. Jano requires a new sample if the initial assay is out of range and the customer desires a result more accurate than Jano's estimate of the out-of-range EU/vial value. SteriGenix replied that they perform successive dilutions with the original sample until the assay falls within the current run's accuracy range, which seems to me like the correct approach.
AngieHolmes
New member
MZ Biolabs yes -- never used them but have them on a list; Sterigenix no, never heard of them. What have you heard? Due to volume I'm expecting new labs to open up so now the trick is knowing who's legit and who's fly by night . . .