Quote:
Originally posted by xcelbeyond
I'm far from an expert on this topic. This has been a very heavy topic over at the Finaplix board when Animal was frequenting there. It was my understanding that while 0.22 will filter out more than 0.45, the harmful bacteria is removed with a 0.45. 0.22 does not technically sterilize either. I'm not well enough versed to articulate the discussion that surrounded this issue but it was pretty intense. There is gear that will be next to impossible to push through a 0.22 filter.
I don't purposely put a pin in (to vent the vial) while baking so alcohol doesn't get "baked-off."
I was told by someone more knowledgable than myself that "process of heating and cooling sterilizes the product."
You seem to understand know this topic relatively well! Can you elaborate on your statement "It takes 122deg celsius to terminal sterilize a surface or product with bacteria contamination"? Isn't 122 C = 251 F?
xcelbeyond /t\
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I work in the formulation development dept of a biopharma company. What we and the FDA call "Terminal Sterilization" is either sending a water or oil based product through a .22um
filter or cooking it to 122.0C. Products that are filled into vials are either kept in an aseptic envioronment, or are filtered by .22um
filters into a final containment vessel. Then that goes directly to the fill line for filling into vials.
As far as gear that does not pass, it can be for many reasons. Mostly that the dissolved powder in not fully dissolved, thus causing the
filter to clog. To be trully dissolved fully you should easily pass through a .22um
filter with a little pressure. If the test comes out of soultion or there is an incrediable bacteria load you will clog the
filter. .45 is better than nothing, but it will still let some bacteria pass. And you are correct, 122=251.6degF. But this temp is used in steam sterilzation with a vent to let the steam pass to all surfaces to sterilize them. But with a liquid formulation it is risky to bake a product because there are a few formulated products that can withstand this heat without denaturing or losing molecular weight. I'm not sure at what temp the testosterone molecule is going to become denatured. You could look that up in the merck index, but it might be close to causing the molecule to become inactive...or not. Hope this helps clarify a few things.
BR