SpartaPharmaUSA (Domestic)

Here. We. Go.

you're using protexics surgical gloves that cost like $3 a pair but you can't afford an autoclave? Also, they're latex, what are you doing to protect against clients that may have latex allergies for something they are injecting? Protexis makes non-latex gloves, switch.

Next you have a filter set up using a peri pump, how are the lines cleaned and sterilized after each run to avoid cross contamination and maintain sterility?

The bottle it's going into has a vent hole haphazardly made into the cap, I can see the burrs left over. That's supposed to be sterile, how long has it been like that and what stops shavings from making it into the media bottle then vial? That's basic quality control, come on.

Next we have a basket with vials just laying in there, why aren't they uniform instead of strewn about, that's how things chip, or at the least grind. Has the basket been sterilized? You mentioned that the vials are put into autoclave bags, where are they? why were the vials not left in the autoclave bags? the sealed bags were sterile, if done correctly, and you've now broken that integrity.

Then we have all the stoppers laying on the counter, again, how were they sterilized, and why were they taken out of the bag and tossed on the open counter?

For the pressure cooker, I don't see any locking lugs, how is that pressure cooker secured and what's the heating source? Based on the measurements compared to the water and alcohol you have a 18-21L pressure cooker, what temperature, pressure and time are you using to sterilize each load? How many vials are sterilized in each load and how are they arranged inside the vessel?

Damn bro; I would never want to get into a argument or debate with you, sir!
 
Leave it to meso to call out sources and teach me things too. If it weren't for the last two pages, my dumbass would have already placed an order.

In the grand scheme of things it’s not the end of the world for a new source, a lot of things are rookie mistakes. But these guys have been in business for at least three years they say and they’re still making rookie mistakes. They looked up too see if a pressure cooker would work and found an article about a dentist using a pressure cooker, if fit their desire so they ran with it . When’s the last time your dentist injected something? When’s the last time you put a tool or your keys in your mouth to hold? The standards of food grade and injection grade are completely different. Compare a kitchen to an operating room to a clean room. All different standards to meet different needs.

The fact they jumped in to a pill press before a bunch of other stuff scares me. There are plenty of articles and studies online how to use an autoclave properly and they’re still fucking it up. How many articles can you find online about how to properly run one of those pill machines? And if I’m understanding them properly they have multiple sets of dies, that’s just asking for trouble from the Gov. Capping sucks, but there are plenty of capping machines out there that can make 100+ caps at a time relatively easy with little mess. I’d trust a China import capper before risking a press, even the cappers are supposed to be regulated here but the supplies to run them are completely lax, they’re caps. Go look for pill binder, or anything else on prime. Now go look for caps on there.
 
Here. We. Go.

you're using protexics surgical gloves that cost like $3 a pair but you can't afford an autoclave? Also, they're latex, what are you doing to protect against clients that may have latex allergies for something they are injecting? Protexis makes non-latex gloves, switch.

Next you have a filter set up using a peri pump, how are the lines cleaned and sterilized after each run to avoid cross contamination and maintain sterility?

The bottle it's going into has a vent hole haphazardly made into the cap, I can see the burrs left over. That's supposed to be sterile, how long has it been like that and what stops shavings from making it into the media bottle then vial? That's basic quality control, come on.

Next we have a basket with vials just laying in there, why aren't they uniform instead of strewn about, that's how things chip, or at the least grind. Has the basket been sterilized? You mentioned that the vials are put into autoclave bags, where are they? why were the vials not left in the autoclave bags? the sealed bags were sterile, if done correctly, and you've now broken that integrity.

Then we have all the stoppers laying on the counter, again, how were they sterilized, and why were they taken out of the bag and tossed on the open counter?

For the pressure cooker, I don't see any locking lugs, how is that pressure cooker secured and what's the heating source? Based on the measurements compared to the water and alcohol you have a 18-21L pressure cooker, what temperature, pressure and time are you using to sterilize each load? How many vials are sterilized in each load and how are they arranged inside the vessel?
I wanted to take a moment and say that I appreciate your thoroughness. Honestly - I wish more boards had members like yourself and Mighty Mouse. I do want to readdress your dismissal of prior study - whether it is being presented by a MD, Clinical Researcher, or DDS is irrelevant. The clinical data- the study was clinically sound. They even included testing its ability to kill one of the most heat-resistant organisms, geobacillus stearothermophilus endospores. If the hardiest of microorganisms is killed, then all other microbes should die as well. When the ampule containing the stearothermophilus endospores is put in the PC and then plated on growth media with NO growth, the autoclave or pressure cooker is clearly working. That particular microbe is used for testing autoclaves all of the time. I want to be clear, I am in no way insinuating that we are resistant or unwiling to buy and use an autoclave. I also want to state that I was not trying to compare a labratory to a field hospital, merely that we use this method because it works and we don't give patients infections from it.

Regarding the latex gloves , I also use and have ample stock of Biogel Synthetic Polyisoprene surgical gloves - they are my preference actually.

Again, I definitely appreciate the thuroughness of your visual inspection and comments.
 
I wanted to take a moment and say that I appreciate your thoroughness. Honestly - I wish more boards had members like yourself and Mighty Mouse. I do want to readdress your dismissal of prior study - whether it is being presented by a MD, Clinical Researcher, or DDS is irrelevant. The clinical data- the study was clinically sound. They even included testing its ability to kill one of the most heat-resistant organisms, geobacillus stearothermophilus endospores. If the hardiest of microorganisms is killed, then all other microbes should die as well. When the ampule containing the stearothermophilus endospores is put in the PC and then plated on growth media with NO growth, the autoclave or pressure cooker is clearly working. That particular microbe is used for testing autoclaves all of the time. I want to be clear, I am in no way insinuating that we are resistant or unwiling to buy and use an autoclave. I also want to state that I was not trying to compare a labratory to a field hospital, merely that we use this method because it works and we don't give patients infections from it.

Regarding the latex gloves , I also use and have ample stock of Biogel Synthetic Polyisoprene surgical gloves - they are my preference actually.

Again, I definitely appreciate the thuroughness of your visual inspection and comments.

Gonna be honest with you. the last "source" that used a PC didnt last long here. It would be a wise decision to make that a top priority sooner rather than later.
 
I wanted to take a moment and say that I appreciate your thoroughness. Honestly - I wish more boards had members like yourself and Mighty Mouse. I do want to readdress your dismissal of prior study - whether it is being presented by a MD, Clinical Researcher, or DDS is irrelevant. The clinical data- the study was clinically sound. They even included testing its ability to kill one of the most heat-resistant organisms, geobacillus stearothermophilus endospores. If the hardiest of microorganisms is killed, then all other microbes should die as well. When the ampule containing the stearothermophilus endospores is put in the PC and then plated on growth media with NO growth, the autoclave or pressure cooker is clearly working. That particular microbe is used for testing autoclaves all of the time. I want to be clear, I am in no way insinuating that we are resistant or unwiling to buy and use an autoclave. I also want to state that I was not trying to compare a labratory to a field hospital, merely that we use this method because it works and we don't give patients infections from it.

Regarding the latex gloves , I also use and have ample stock of Biogel Synthetic Polyisoprene surgical gloves - they are my preference actually.

Again, I definitely appreciate the thuroughness of your visual inspection and comments.

Jut because it works in a laboratory setting doesn’t mean it’s the right way to do it. You’re quoting an article that was written on how to provide dental work in the field, in a third would country. Yes it can kill bacteria, that’s not the point, the point is the QUALITY. You’d have to follow those sesifications to the letter to get the results they got but even then those tests for a study were still don’t in a lab my pros. They are not advocating the use of a pressure cooker for lab work, they are stating that in a third world country a pressure cooker would be possible. The only “professionals” you’ll see use pressure cookers are schools where they’re trying to demonstrate sterile techniques but ensuring 100% sterility isn’t nessesary as schools aren’t injecting anything.

The point is this, you are not emphasizing quality and security like you stated in the beginning. Everything has been about quantity; the number of tabs, the number of customers, the number of labels, the number of caps you aren’t making, the number of boards you’re on and the number of people you can expand and reach to.

Also, let’s not forget all of the other questions I asked, the only one you addressed was the gloves. There’s probably a dozen more in there to answer.
 
Jut because it works in a laboratory setting doesn’t mean it’s the right way to do it. You’re quoting an article that was written on how to provide dental work in the field, in a third would country. Yes it can kill bacteria, that’s not the point, the point is the QUALITY. You’d have to follow those sesifications to the letter to get the results they got but even then those tests for a study were still don’t in a lab my pros. They are not advocating the use of a pressure cooker for lab work, they are stating that in a third world country a pressure cooker would be possible. The only “professionals” you’ll see use pressure cookers are schools where they’re trying to demonstrate sterile techniques but ensuring 100% sterility isn’t nessesary as schools aren’t injecting anything.

The point is this, you are not emphasizing quality and security like you stated in the beginning. Everything has been about quantity; the number of tabs, the number of customers, the number of labels, the number of caps you aren’t making, the number of boards you’re on and the number of people you can expand and reach to.

Also, let’s not forget all of the other questions I asked, the only one you addressed was the gloves. There’s probably a dozen more in there to answer.
So I'll use you words in the form of numbered questions, and my answers corresponding with the same number.

Or I'll make a typo so we will see




Question 1
you're using protexics surgical gloves that cost like $3 a pair but you can't afford an autoclave? Also, they're latex, what are you doing to protect against clients that may have latex allergies for something they are injecting? Protexis makes non-latex gloves, switch.

Next you have a filter set up using a peri pump, how are the lines cleaned and sterilized after each run to avoid cross contamination and maintain sterility?

Answer 1
The lines are actually replaced entirely. The tubing is dirt cheap. All tubing is washed with aloconox solutoin , then rinsed with distlled water, and then bathed in distilled water and Isopropyl alcohol and then steam sterilized.

Question 2
The bottle it's going into has a vent hole haphazardly made into the cap, I can see the burrs left over. That's supposed to be sterile.

Answer 2
The entire cap setup was/is steam sterilized and the underside of the cap is sealed and smooth

Question 3
Next we have a basket with vials just laying in there, why aren't they uniform instead of strewn about, that's how things chip, or at the least grind. Has the basket beensterilized? You mentioned that the vials are put into autoclave bags, where are they? why were the vials not left in the autoclave bags? the sealed bags were sterile, if done correctly, and you've now broken that integrity.

Answer 3
I want to be clear - we use factory sterilized vials to be more efficient that come with both the silica stoppers and the vials themselves. Yes we used sterilization pouches prior when we were still doing it ourselves. We do still sterilize our larger media - flasks / beakers etc. For these we do not use sterilization pouches.The tops are covered with pre treated aluminum foil with sterile gloves and placed in a oven set at 350 F to dry any residual sterile water from the PC. Of course the mesh basket is run through the PC and transferred into the flow hood with sterile glvoes just like everything else.The vials are not clanking around in the basket or grinding ...there is very little movement except being picked up out of the basket and set down to fill. The stoppers are picked up with sterilized hemostats , the tips of which are never touched, and the handles being touched only with sterile gloves, and are placed on the vials after being filled. They are then rubbed with chlorahexidine and finally capped.

Question 4
Then we have all the stoppers laying on the counter, again, how were they sterilized, and why were they taken out of the bag and tossed on the open counter?

Answer 4
The silica stoppers are, rather were as we have transitioned to presterilized vials and stoppers, ran through the PC after receiving a bath in distilled water and alochol. They were removed from the PC (they were placed in a mesh basket to keep off the bottom of the cooker) and placed in the flowhood.

Question 5
For the pressure cooker, I don't see any locking lugs, how is that pressure cooker secured and what's the heating source? Based on the measurements compared to the water and alcohol you have a 18-21L pressure cooker, what temperature, pressure and time are you using to sterilize each load? How many vials are sterilized in each load and how are they arranged inside the vessel?

Answer 5
Our goal temp is 127C at 20PSI and 30 minutes time. The pressure cooker has an interlocking steel seal and holds pressure quite well.

Am I missing anything?? Or is this enough
 
Also, the fact you didn't question shoving dirt in an open wound tells me you don't realize there's half a dozen other routes to take for much more sterile wound care before you get to that point. Actually, I can't think of a situation it could get that bad. So you trying to talk about emergency medical situations as an excuse to not use the best practices is laughable
You better use my IFAK before you go shoving dirt in my wound. lol.
 
“Question 2
The bottle it's going into has a vent hole haphazardly made into the cap, I can see the burrs left over. That's supposed to be sterile.

Answer 2
The entire cap setup was/is steam sterilized and the underside of the cap is sealed and smooth“


If it’s sealed and smooth how is it venting? Or are you saying the tube was put in and and sealed in place? If so what was used to seal it? There aren’t many things you seal a hole with people want insode their body. And why not de-burr it to begin with, it would have avoided all these questions.
 
“Question 2
The bottle it's going into has a vent hole haphazardly made into the cap, I can see the burrs left over. That's supposed to be sterile.

Answer 2
The entire cap setup was/is steam sterilized and the underside of the cap is sealed and smooth“


If it’s sealed and smooth how is it venting? Or are you saying the tube was put in and and sealed in place? If so what was used to seal it? There aren’t many things you seal a hole with people want insode their body. And why not de-burr it to begin with, it would have avoided all these questions.
I prefer jbweld.
 
I just noticed that @SpartaPharmaUSA got his silver tag for donating. Very nice sir. That is a leap in the right direction. Dont get discouraged about the vetting, these guys are here for harm reduction for the community. Their advice is pure gold for a source.

@BigBaldBeardGuy @T-Bagger he got his donation tag, Silver level gentlemen.

Good. Fix some basic issues and this source may actually go somewhere here.

I’ll never be comfortable with the tabs and the lack of knoweledge with the mixer doesn’t make me feel any better.
 
I just noticed that @SpartaPharmaUSA got his silver tag for donating. Very nice sir. That is a leap in the right direction. Dont get discouraged about the vetting, these guys are here for harm reduction for the community. Their advice is pure gold for a source.

@BigBaldBeardGuy @T-Bagger he got his donation tag, Silver level gentlemen.
I understand TX, I walked into this knowing that I'd be vetted "Meso style"

Look at it this way, if what you say is true, that this is for the protection of meso members, than I agree with it.

Though as I'm sure we are aware it can be taxing on time and effort, I have no choice bit to agree with it.
 
I just noticed that @SpartaPharmaUSA got his silver tag for donating. Very nice sir. That is a leap in the right direction. Dont get discouraged about the vetting, these guys are here for harm reduction for the community. Their advice is pure gold for a source.

@BigBaldBeardGuy @T-Bagger he got his donation tag, Silver level gentlemen.
Also, thank you. Yes, we donated
 
I just noticed that @SpartaPharmaUSA got his silver tag for donating. Very nice sir. That is a leap in the right direction. Dont get discouraged about the vetting, these guys are here for harm reduction for the community. Their advice is pure gold for a source.

@BigBaldBeardGuy @T-Bagger he got his donation tag, Silver level gentlemen.
Definitely a step in the right direction. This guy definitely isn’t Venom lol.
 
I understand TX, I walked into this knowing that I'd be vetted "Meso style"

Look at it this way, if what you say is true, that this is for the protection of meso members, than I agree with it.

Though as I'm sure we are aware it can be taxing on time and effort, I have no choice bit to agree with it.
It's been pretty tame in here tbh. Stop by the lionshead thread. Cant post in there, but definitely worth the read. Classic example of what happens when you do everything wrong.
 
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