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Sanitiser
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Hi guys
Can you post your ethanol suppliers, the ones we work with are all out of stock. -
Hey Guys,
Read through all the comments..
Has anyone been able to get a Gel Hand Sanitizer with Isopropyl 99% and Carbomer 940?
Im currently using the following formula:
65% Isopropyl
.5% Carbomer
2% Glycerin
1% Rosewater
1% Lavender/Teatree EO
TEA- ~.3ml
30% H2OHaving a very hard time getting a gel out of this, I’ve tried a couple of different variations (some with not EO or rosewater) still nothing.
Any recommendations? maybe my process is off?
I’m not looking for a super thick gel, just something that wont be water like and will be able to be used with a small treatment pump
I also have Sepimax Zen Coming in next week, to try.
Thanks in advance!
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To begin, 1% EO is at least ten times the amount you should be using.
Secondly you are not doing this in a science based way. We do not measure things in ‘drops’ and ‘to bring pH up’ is not the way. Use the manufacturer’s recommendation for neutralisation. -
@Belassi I have also tried keeping the EO out. Im measuring TEA in ml, just used the drop reference as an average. Sorry about that
. roughly .3ml -
Im measuring TEA in ml
- No, this is still not correct. Work in grams. The only time you use volumetric measure when preparing a sanitiser is when measuring the alcohol and water components. Weigh the carbomer and use the appropriate recommended amount of TEA. -
@Belassi I’ll look into this and figure our exactly what I’m using in grams. I’m measuring the alcohol and water in volume, the other ingredients in grams, I’m measuring the TEA in ml, I’ll look into it a little more to figure out what the manufacturer recommends.
thanks
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Pharma said:@Belassi You’re not going to kill spores with lavender EO. What you need is one or several of the following strategies:- Use another oxidising agent: Iodine or hypochlorit comes to mind- Cook the sh*ç@ out of your product (not to recommend with gels and alcoholic products, you know why better than I do :blush: )- Use sterile filtration (not easy with gels and doesn’t solve container contamination and the like)- Don’t care about spores (for more or less clean raw materials and GMP/GxP an acceptable decision)- Use an aldehyde: Formaldehyde and glutaraldehyde are common but require uncomfortably high levels to go from sporistatic to sporicidal. As an educated guess, aldehyde containing EOs might be an option (unfortunately, that includes several of those which have to be labelled due to allergic potential exactly due to presence of reactive aldehydes).The trick with spores is that they are very tough nuts to crack and require removal, heat (for some species even more than the product can take), or chemical reactions. Lavender EO contains mostly hydrocarbons as well as phenols and esters thereof which do not undergo necessary chemical reactions with spores. If you need inspiration which to choose, döTerra as an example has a list for possible candidates (first hit asking Google).BTW go somewhat acidic (alkaline would work too but destroys the skin acid mantle and that’s obviously bad, worse regarding the current situation).
We are actually considering making a sterile filtered WHO formula based sanitizer.
I wonder what do we can do to sterilize the containers as they are not heat resistant thus not autoclaveable?
In fact, a proposed formulation will be sold in a spray bottle.Soaking the bottles in a glutaraldehyde solution and then rinsing them looks like an interesting option.
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You don’t need to sterilise containers that are filled with a sanitiser!
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Belassi said:You don’t need to sterilise containers that are filled with a sanitiser!
Well, it look like overkill but specs call for a sterile sanitizer.
(Mostly intended for medical/hospital use).Some rare bacteria and spores can actually survive in sanitizer fluid, hence the specs to make it sterile.
Right now we’re disussing if we should sterile filter only the water, or the whole finished WHO/FDA/CDC based formula. I’m propossing to sterile filter the whole formula, to be on the safe side.
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You won’t get the whole formula through the membrane, or it will take forever. You’ll be insane in the membrane, insane in the brain! You can hardly autoclave the container anyway… I guess you could use a hydrogen peroxide bath… sounds expensive and risky. (H2O2 freaks me out. I am hyper-aware of all the unstable, explosive peroxides that can accidentally be created.)
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QUOTE:
When alcohol 95% is mixed with Hydrogen Peroxide it will react forming acetic acid, no matter what is the dilution. In concentrated form it will react violently, confirming reactivity. In dilute solution the reaction also depends on the exposure to sunlight as well, UV rays. So academically, the answer is yes, both will react, extent differs on conditions.I fully disagree with hand sanitizers containing peroxides. as per WHO recipes. WHO is poor in chemistry, so beware of WHO recommendations! The sanitizers will change with time as it does not contain any UV blocker. I have come across a formulation from G.B. it is wonderful, well balanced formulation.
(from stack exchange) -
These articles and studies suggest that a catalyst is needed for significant amounts of alcohol to by oxidized.
Ferric ions:
https://pubs.rsc.org/en/content/articlelanding/1967/j1/j19670001409#!divAbstract
https://www.tandfonline.com/doi/pdf/10.1080/17518253.2014.939721Gamma irradiation:
https://www.nrcresearchpress.com/doi/pdf/10.1139/v70-441Strong acid catalyst:
http://www.sciencemadness.org/talk/viewthread.php?tid=8661triethyl({2,4,6-trimethyl-3,5-bis[(triethylazaniumyl)methyl]phenyl}methyl)azanium (tribromide)based phosphotungstate complex (TBAP) catalyst:
http://www.arkat-usa.org/get-file/45161/Light + enzymes:
https://pubs.acs.org/doi/pdf/10.1021/j150345a008 -
If there’s no gelling agent, the right type/material of membrane will work well for alcoholic aqueous solutions. Question is rather, what ‘they’ understand with ‘sterile’. If they really mean sterile, you will have to use gamma irradiated containers which are then filled in a sterile/aseptic environment (for example using underpressure filtration through 0.2 or 0.45 um membranes directly into sterile bottles) and tightly sealed. By preference, you’ll using a pump system for the bottles with a sterile filter like those used for preservative-free eye drops to keep it sterile throughout usage period.Which quantity are you intending to produce? -
what about ETO sterilizaion? @Pharma . Sanitizer used to sterilize. Is it require to to sterilize it?
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amitvedakar said:what about ETO sterilizaion? @Pharma . Sanitizer used to sterilize. Is it require to to sterilize it?
If it’s for medical or hospital use, then yes, it needs to be sterile.
There are some rare bacteria or spores that can survive, even inside 70% alcohol.Pharma said:If there’s no gelling agent, the right type/material of membrane will work well for alcoholic aqueous solutions. Question is rather, what ‘they’ understand with ‘sterile’. If they really mean sterile, you will have to use gamma irradiated containers which are then filled in a sterile/aseptic environment (for example using underpressure filtration through 0.2 or 0.45 um membranes directly into sterile bottles) and tightly sealed. By preference, you’ll using a pump system for the bottles with a sterile filter like those used for preservative-free eye drops to keep it sterile throughout usage period.Which quantity are you intending to produce?It will be a 1000 L batch.
Sterile filtered with a 0.22 um filter (they can be used either with positive pressure above, or with vacuum below).
As far as I know, 0.45 um filtering ain’t truly sterile.The gamma irradiated bottles will be the hard part.
Hence why I was considering soaking them in glutaraldehyde solution and rinsing with sterile filtered water. -
Gunther said:amitvedakar said:what about ETO sterilizaion? @Pharma . Sanitizer used to sterilize. Is it require to to sterilize it?
…
As far as I know, 0.45 um filtering ain’t truly sterile.The gamma irradiated bottles will be the hard part.
Hence why I was considering soaking them in glutaraldehyde solution and rinsing with sterile filtered water.Ethylene oxide could be an option too…Depending on the definition of sterile and also the type of liquid and it’s application, 0.45 um can be acceptable (I usually used 0.2 um).Washing is not an option because you would have to dry the bottles somehow and glutaraldehyde is neither an approved nor safe method (and requires 1000 l glutaraldehyde solution and at least 3-5000 l sterile water).I can only tell you about personal experience (I used to work in BSL2 labs for years) and how it is in Switzerland.I worked with untested human blood, multiresistant pathogenic bacteria, cancer and primary cell lines, radioactive material, and unstable, highly reactive, and deadly chemicals. It’s easier to keep something in your bottles than out of them! It’s also easier to train people to handle bottles with potentially deadly content than teaching them to work under aseptic conditions.Here, if you want something labelled ‘sterile’, it has to be registered which means your company has to be approved. Getting approval for sterile production is probably second to opening a lab which deals with SARS, Ebola and other deadly diseases. You will have to build a clean room (or a clean building), deal with authorities, pay fees, remodel sanitary and ventilation installations, train your staff, set up many SOPs, test raw materials, do in-process controls, and determine end product quality, set up a microbiology lab, deal with more authorities, run, evaluate, and re-run your whole process using hundreds of litres and bottles, adjust SOPs and write more SOPs, re-train staff, get document signed, pay more fees… we’re talking about an investment of easily more than 10 million $ over more than 2 years before you may not even get a ‘good to go’!What small to medium companies do here is outsourcing sterile production to approved manufacturers even if they produce on a regular basis over years
.BTW this is regarding production of liquids. It’s easier for hard
materials using ethylene oxide or gamma radiation where standardised
equipment exists. You could hence try to ‘nuke the living sh”*ç’ out of your bottles… but getting a giant ray gun just for a bathtub full of sanitiser???
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