Sterile injection liquids

[Solipsis]

Hi everyone,

I was just wondering, are there different levels of sterility or different standards for which products are made? For example there are sealed plastic vials of physiological saline being sold at my pharmacy for intranasal use in infants. This product has a Sterile A label (made with aseptic procedure):

However IIRC it says what it is and is not meant for. What I am wondering is: do they have to put this on the product by law just to cover their ass but is it safe to use for I.M. injections? Or is this actually risky and not as sterile as one might hope?

Also, if a 0.2 micron wheel filter (if I have that particle size right) is used, does that make the point moot? Seems to me like that should be fine but I'd like to confirm that with some of you who have the knowledge and experience.

Even though I'm a mod, I am not 100% sure this is the right forum - if not sorry and I'll just see it being moved. Thnx!

 

[bronson]

I don't know the answer to your question. I do think this might be better suited to OD. I'll leave it here for a bit, and then send it their way if we don't get enough info, assuming that sounds agreeable to you.

 

[Swimmingdancer]

Yes there are different "levels" of sterility assurance (probability that a unit would not be sterile, for example 1 in a million) and different standards by which products are made depending on their use.

The label "Sterile A", however, does not refer to a specific sterility assurance level but means that it is sterilized and undergoes "aseptic processing". Aseptic processing is a method of producing and packaging sterile products in which sterile bulk product is filled into sterile containers in a controlled environment, in which the air supply, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels.

It is to differentiate between aseptic processing and "terminal sterilization". Terminal sterilization generally involves filling and sealing product containers under conditions that minimize the microbial and particulate content but are not sterile, and then the product in its final container is subjected to a sterilization process. Whereas in an aseptic process, the product, container, and closure are first separately sterilized and then brought together under sterile conditions. There are advantages and disadvantages to each method.

However IIRC it says what it is and is not meant for. What I am wondering is: do they have to put this on the product by law just to cover their ass but is it safe to use for I.M. injections? Or is this actually risky and not as sterile as one might hope?

Water or saline intended for injection would have to meet higher sterility standards than water or saline not intended for injection but still required to be sterile. Something like a syringe or a liquid intended for IV may be required to have a probability of no greater than a 1 in 1,000,000 chance of finding a non-sterile unit, whereas a solution for intranasal use might only be required to have a probability of a no greater than a 1 in 1,000 chance of finding a non-sterile unit (*I am not sure if this is the real number for the particular solution you are referring to). If something does not meet the minimum requirement for IV use it may say "sterile, not intended for injection" on the label for legal protection.

When I worked at a needle exchange we would give out sterile ampoules of water that were "not intended for injection" and the organization and nurses felt it was sufficiently safe for drug users to inject, for what it's worth. Even if it has a greater probability of a unit not being sterile, something manufactured to be sterile enough to use in your eyes or nose should presumably not have a dangerous level of contamination, even if a given unit was not actually completely sterile - does that make sense?

Also, if a 0.2 micron wheel filter (if I have that particle size right) is used, does that make the point moot?

A 0.2 micron filter would only remove anything above that size, which would include many larger bacteria and particles; I think it would have to be contaminated with something pretty nasty or unusual for that size filter to not remove it, which I think would be unlikely with sterile saline solution.

 

[Solipsis]

Thanks a lot, I was suspecting something almost exactly along those lines but you totally cleared it up for me. I appreciate you taking the time.

Moving to OD won't be necessary for me, I doubt that eliciting a whole discussion will change my feelings about the matter and people who say they take certain risks but never had an incident typically don't persuade me... but then again I am generally curious about people's I.M. habits.

I'd even be fine with you considering this answered and it being closed, your call.

 

[crazycatman]

You can find sterile water and bacteriostatic water (has some benzyl alcohol added so you can use it with multi use vials without worrying too much about bacterial growth between uses (at least if you follow other practices to insure sterility)) intended for injection on various online shops.

However even if the water is sterile, whatever you're intending to inject probably isn't so using a micron filter would still be a good idea.

 

[Swimmingdancer]

Thanks a lot, I was suspecting something almost exactly along those lines but you totally cleared it up for me. I appreciate you taking the time.

Moving to OD won't be necessary for me, I doubt that eliciting a whole discussion will change my feelings about the matter and people who say they take certain risks but never had an incident typically don't persuade me... but then again I am generally curious about people's I.M. habits.

No problem I like to be thorough. Since you said you were curious, FWIW I used water and saline at this level of sterility 1000s of times for IV and maybe ~100 times for IM with no problems and wouldn't hesitate to use it again (if I were injecting drugs), it is a huge step up from what most injection users use, and it's easily accesible. Contamination during prep or from the drugs is much more likely.