Practicality will depend upon how far an UGL is willing to go to make the end user happy and safe. One of the guys I consulted with before starting to brew myself has a private UGL and has been in the business For years. He takes every step he can to ensure things are done right. There are probably other labs that do the same while many labs just do the minimum. I would personally prefer a lab that went above and beyond.
In his applications, Johne71 mentioned a process which included NaOH which I've also seen mentioned other places. It's a good method to help but NaOH and/or bleach alone is not sufficient for my standards. For glassware and vials I will continue to use dry heat, 500deg F for 1hr or more, until a better method becomes available that I have access to. Filtering the oil with a .22um filter is standard for sterilization. If you want to also make it pyrogen-free and have an added measure of safety, you can use a .1um filter or a charged .22um filter (although most of the charged ones I've seen are hydrophilic and made for aqueous solutions so you'll have to look for one made for oil based)
Well, I can't protest any individual or UGL going to those measures to ensure the safety of the final product for injection. I can't. However, for practical considerations, I am interested in achieving a safe product via the most conservative practices possible. As far as I'm concerned the lengths that you could go to and precautions you could take are limitless, but at some point it would become completely impractical. The steps that you've described aren't impractical by any means, but I'm still not convinced that they are necessary. You're a smart dude, so let's up the anti a bit.
For those who don't know, the NECC fungal meningitis outbreak was a pretty big deal. A compounding pharmacy managed to pump out a bunch of injectable methylprednisolone acetate, a steroid, that resulted in 800 confirmed cases of fungal meningitis. For all intents purposes, this was basically a UGL that made a funky batch of AAS and killed quite a few people. I mean it wasn't basically that--it WAS that. They weren't licensed to make the steroids either. So what the fuck went wrong was that they cut major corners and I don't even think they tested the final product, which is perfect because UGL's don't either. Too impractical.
Anyway, these dipshits had a major black mold problem and they made steroids in a contaminated environment. Now remember how I mentioned that taking your vials out of the autoclave before you dispense your gear into them compromises sterility, and how that's a BIG fucking deal and completely fucks the chain of sterility? This is exactly why. Contaminated air. Boom. It's game over. Your shit is no longer sterile. And this is where I get to gloat a little bit. Because you know what they did to their final product? THEY AUTOCLAVED IT. yes...and I seem to recall being called a retard for suggesting that Elite used the autoclave on his finished product. Tsk tsk. But I've forgiven and forgotten. So long story short...they didn't sterilize properly in the autoclave, and their finished product was contaminated with black mold. But they DID use an autoclave, and still managed to fuck that up.
I may stand to be corrected here, but I did a little bit of digging, and I came to the conclusion that this ENITRE outbreak could have been prevented if ONE precaution had been taken, and one only: .22 micron filtration. I believe the fungal agents that caused the meningitis could have been filtered out with a .22 micron filter. I would like to point out that I have been homebrewing for 1.5 years, and the only measure of sterility I have ever taken is using a .22 micron filter, and i have never had any injection complications.
Thoughts?
