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Homebrew Method CritiquesLena's Ultimate Guide

Critique: Lena’s Ultimate DIY Guide

You can read about the spirit of the critique here.

Lena basically pioneered DIY, at least the online version of it. She deserves enormous respect. It would be great if she would update the methods she teaches to reflect more modern practices.

Lena publishes her guide on a wiki. My critique is written in response to a Feb ā€˜25 archive of the wiki here . The live wiki lives here .

The Guide

Lena’s guide is not complex enough to warrant a full critique. Her method can be summarized rather quickly: she recommends you take an empty vial, put all the raw ingredients in it, cap it, shake it, then boil the vial for 30 minutes. Simple as that.

Here’s a quote from the guide:

Those scientifically-appearing (at first glance) claims (mentioning standards and quoting articles) were published as a marketing tool, to denigrate a competitor (me). Noone of my 3800 customers complained of infection. Why? Because actually it’s the opposite: terminal heat sterilization is more reliable than filtering + aseptic procedures.

  1. Science is real and it’s useful to quote it
  2. It’s cool that 3800 customers are happy. We, however, have no way of verifying this. I’ve seen plenty complaints about Lena on reddit. Lena is actually banned from posting on r/transdiy. It’s also not super cool to test unverified, untested methods directly on humans, which is what this is.
  3. There’s no sterility assurance testing happening and no science being referenced so these are super bold claims.
  4. Using an autoclave (or even boiling) a non-aqueous solution does not meet the definition of terminal sterilization, so using that term is inaccurate. If it did work, it would indeed be more reliable than the dangerous and difficult aseptic process. Making HRT is hard.

In fact, making HRT is exceptionally difficult. It would be so wonderful if there was a reliable method that we knew ā€œjust workedā€ and didn’t require all sorts of fussing around. The unfortunate reality is that compounding pharmaceuticals isn’t so simple, and if it was, would not be so highly regulated of a process.

I hope you can see that the person who writes this guide is operating on the defensive, accusing those criticizing her of being her competitors. She did not take any time to investigate or properly refute scientific claims made against her practices, just is telling people that she’s correct and to trust her. I’d personally choose to trust the 1,000s of hours of research I’ve done into safe compounding practices.

Here are a few major issues with Lena’s method:

Filtering is Required

Let’s suppose that filtration isn’t essential for sterilization of our preparation (which it is). Properly washing the vials is still an essential component to removing any debris that might be in the glass leftover from manufacturing. Additionally, the excipients need to be filtered as well to ensure there’s nothing in them that’s not supposed to be.

You should be very certain and clear that there is no dust or anything else in your vials. Filters are how we do that.

Don’t inject dust.

Boiling a Vial is Not Sterilization

I’ll refer you to the sterilization theory page which has the full explanation as well as links to sources.

  1. Boiling a vial gets the contents of the vial up to 100C.
  2. Sterilization that doesn’t have steam contact needs to be heated to 160C for two hours.
  3. If the contents of the vial were water (which they’re not) then it would still need to be heated to 121C.
  4. Boiling a vial is heating Benzyl Alcohol past it’s max temperature (more info)

Boiling for sure kills some bacteria. And hell, maybe in some certain scenarios it’s killing most of it. But since we can’t actually see down to the microscopic level, we can’t know if it was effective or not, not without extensive testing.

Benzyl Alcohol is Not Optional

At one point in the guide Lena says:

you may optionally draw 0.2 ml of benzyl alcohol into a syringe, pour it into the vial … If you don’t add the preservative then make sure that each time you draw from a sterilized vial, you take a new syringe. … Without preservative is rumored unsafe, but my customers including those 36 and myself never had an infection because terminal heat sterilization is superior to filtering + aseptic procedures

As well as in other places she mentions that BA is optional, though she does include it in the vials she sells.

You should always use a new syringe and needle each time you draw, the fact she says this is so telling as to what her understandings of even basic aseptic technique is.

There are so many reasons people have not had an infection, but the number one probably being that humans are generally more powerful than a small dose of bacteria being put into our muscles. All the science says that these methods are not reliable in removing bacteria. One day the wrong type of virus or bacteria could make their way into vials that are prepared like this, won’t be killed by the boiling, and will give someone an infection.

People do get infections  (and in very rare cases die ) from improperly prepared vials. Thank god it hasn’t happened to trans people (as far as we know), but as DIY grows and misinformation like what Lena spreads grows, it becomes more and more likely to happen.

Please don’t follow Lena’s guide.

If you need a simple way to make a couple vials, my guide is better written, only nominally more expensive, and follows compounding best practices designed to be done on a desk in your home. Read that here.

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