Critique: Lenaās 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 ā25 archive of the wiki hereā. The live wiki lives hereā.
The Guide
Lenaās 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.
Hereās 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 itās the opposite: terminal heat sterilization is more reliable than filtering + aseptic procedures.
- Science is real and itās useful to quote it
- Itās cool that 3800 customers are happy. We, however, have no way of verifying this. Iāve seen plenty complaints about Lena on reddit. Lena is actually banned from posting on r/transdiy. Itās also not super cool to test unverified, untested methods directly on humans, which is what this is.
- Thereās no sterility assurance testing happening and no science being referenced so these are super bold claims.
- 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 ājust workedā and didnāt require all sorts of fussing around. The unfortunate reality is that compounding pharmaceuticals isnāt 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 sheās correct and to trust her. Iād personally choose to trust the 1,000s of hours of research Iāve done into safe compounding practices.
Here are a few major issues with Lenaās method:
Filtering is Required
Letās suppose that filtration isnāt 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 thereās nothing in them thatās 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.
Donāt inject dust.
Boiling a Vial is Not Sterilization
Iāll refer you to the sterilization theory page which has the full explanation as well as links to sources.
- Boiling a vial gets the contents of the vial up to 100C.
- Sterilization that doesnāt have steam contact needs to be heated to 160C for two hours.
- If the contents of the vial were water (which theyāre not) then it would still need to be heated to 121C.
- Boiling a vial is heating Benzyl Alcohol past itās max temperature (more info)
Boiling for sure kills some bacteria. And hell, maybe in some certain scenarios itās killing most of it. But since we canāt actually see down to the microscopic level, we canāt 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 donāt 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, wonāt be killed by the boiling, and will give someone an infection.
People do get infectionsā (and in very rare cases dieā) from improperly prepared vials. Thank god it hasnāt 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 donāt follow Lenaās 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.