MyoGen SustaGen 250 - HPLC/TAMC/TYMC - 2019-03 - SIMEC via AnabolicLab.com

SIMEC switched from a quantitative test for bacteria to a qualitative test.

So rather than 'count' to detect certain number of bacteria, SIMEC provides a 'yes or no' answer to whether the sample contains any bacteria, yeast or mold at all.
The details are what worries me. For example PCR might be considered a qualitative test for bacteria, BUT positive PCR does not necessarily mean that the sample is not sterile.

I've seen that mistake done hundreds of times in professional settings.
 
That "N" means that the said test is not accredited nor validated.

Also @Millard Baker recently mentioned that SIMEC changed their microbiological contamination protocol, but provided no further information.

@AnabolicLab.com can you please contact SIMEC to confirm it it's a typo or if microbiological contamination was actually found.

Because if it's the latter, the report should have listed some kind of measure of how many bacteria were found (i.e. CFU/g or Most Probable Number)

We don't want to contact directly or indirectly SIMEC, we do not want to interfere with the work of Anaboliclabs. We submitted this same request directly to Anaboliclabs team because we need the same precision as you,
@AnabolicLab.com

@Andre-Myogen but I find it hard to believe that they sourced 4 pharma grade testosterones, only to skip sterile filtration.

Yes, especially when the SustaGen 250 production video shows washing, filling and direct sealing of amps. All process done under sterile area.

And as you say :
actual content of 62 mg/ml testosterone phenylpropionate, 65 mg/ml testosterone isocaproate, 104 mg/ml testosterone decanoate and 31 mg/ml testosterone propionate.

Having this good result 1 year after the manufacturing of the products (no alterations) does not really make sense without also having a surgical sterilization.


We worked with several labs to test our quality before each product release (in addition to those required for the government). We are also open to any independent lab here that wants to test our products, we will comply to their process.

Now, we are waiting for an update of Anaboliclabs.
 
We don't want to contact directly or indirectly SIMEC, we do not want to interfere with the work of Anaboliclabs. We submitted this same request directly to Anaboliclabs team because we need the same precision as you,


Yes, especially when the SustaGen 250 production video shows washing, filling and direct sealing of amps. All process done under sterile area.

And as you say :
actual content of 62 mg/ml testosterone phenylpropionate, 65 mg/ml testosterone isocaproate, 104 mg/ml testosterone decanoate and 31 mg/ml testosterone propionate.

Having this good result 1 year after the manufacturing of the products (no alterations) does not really make sense without also having a surgical sterilization.


We worked with several labs to test our quality before each product release (in addition to those required for the government). We are also open to any independent lab here that wants to test our products, we will comply to their process.

Now, we are waiting for an update of Anaboliclabs.

Can you please post pics of the culture media plates (or Petrifilm) that you use for microbiological quality control?
Please describe the QC process.

Better yet, can you please post the inoculated and incubated plates, showing no (microbiological) colonies growth?
 
This is the description of the new TAMC/TYMC method provided by the head of the SIMEC microbiological lab:

"The detection technique for the determination of the TAMC and the TYMC was adapted by us from a quantitative to a qualitative method. This was due to the water-immiscible properties of many products and the greater sensitivity of the qualitative detection. The new method works with an enrichment process based on Tryptic Soy Broth (TSB) to which an emulsifier (Tween 80) is added. The sample is added to this culture medium under aseptic conditions in a ratio of 1:10, mixed and then incubated at 30°C for 5 days. If bacteria or fungi are present in the product, they multiply in the culture medium and lead to turbidity. Because the product itself can also lead to turbidity of the culture broth, 0.1mL of the incubated broth culture is pipetted to 9mL TSB and incubated again. If turbidity can be detected in the second broth culture, bacteria and/or fungi have grown and the detection of the bacteria is positive. To differentiate whether fungi are also present in the culture, some material from the second broth culture is inoculated into a liquid medium which is selective for fungi. If this also shows a turbidity after incubation, the detection of yeasts and moulds is positive."
 
This is the description of the new TAMC/TYMC method provided by the head of the SIMEC microbiological lab:

"The detection technique for the determination of the TAMC and the TYMC was adapted by us from a quantitative to a qualitative method. This was due to the water-immiscible properties of many products and the greater sensitivity of the qualitative detection. The new method works with an enrichment process based on Tryptic Soy Broth (TSB) to which an emulsifier (Tween 80) is added. The sample is added to this culture medium under aseptic conditions in a ratio of 1:10, mixed and then incubated at 30°C for 5 days. If bacteria or fungi are present in the product, they multiply in the culture medium and lead to turbidity. Because the product itself can also lead to turbidity of the culture broth, 0.1mL of the incubated broth culture is pipetted to 9mL TSB and incubated again. If turbidity can be detected in the second broth culture, bacteria and/or fungi have grown and the detection of the bacteria is positive. To differentiate whether fungi are also present in the culture, some material from the second broth culture is inoculated into a liquid medium which is selective for fungi. If this also shows a turbidity after incubation, the detection of yeasts and moulds is positive."

So essentially, yes, the gear was contaminated.
 
No sir. No swamp water, sir. Just fresh water straight from the Ganges, sir. You very bad man for saying i brew swamp water.

View attachment 117990

(Yes, that's a legit picture of the Ganges River. They should be ashamed.)

LoL pharmacomstore is running out of brands with no contamination, there is no better time to get balkan pharmaceuticals and SP labs, but only new design boxes please ;)
 
Could you please inquire about how do they conduct negative controls?

I believe that labsite contamination is just as likely as that the samples were indeed contaminated. Negative controls help to disprove that, so I inquired about it.

The response from the head of the SIMEC microbiological department:

"The samples first enter the microbiology lab. There they are brought into a qualified laminar flow, disinfected on the outer surface and opened. The bouillon cultures are then inoculated with sterile utensils in the sterile workbench. The sealed samples are then transferred to the chemistry department for the chemical analyses.

"During testing, negative controls of the culture medium are carried along, the medium itself is checked with test strains (growth control)."
 
The response from the head of the SIMEC microbiological department:

"The samples first enter the microbiology lab. There they are brought into a qualified laminar flow, disinfected on the outer surface and opened. The bouillon cultures are then inoculated with sterile utensils in the sterile workbench. The sealed samples are then transferred to the chemistry department for the chemical analyses.

"During testing, negative controls of the culture medium are carried along, the medium itself is checked with test strains (growth control)."
Thank you!
 
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