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Surgical Hand Scrub for Hospital use.
Dear members,
My query is regarding the formulation of surgical hand scrub for hospital use. I have tried formulating the product using the formula as follows:
Phase I
1. Ethanol 99.9% : 350 ml
2. Chlorhexidine Gluconate: 20 ml (0.5% w/v)
3. Glycerol 98% : 3 mlPhase II
4. Hydroxyethyl Cellulose : 2 gm
5. Lauramine Oxide: 10 gm
6. Purified water : q.s to 500 mlThe resulting product was visually hazy. The product did not produce any foam as is expected from any hand washing soap. The product felt warm while usage.
I am a novice in this field and this formulation felt like a mistake. The product which I referred for the above formulation is Hydrex Surgical Scrub produced by Ecolab.
I am well aware of the fact that this prestigious forum is much more than a platform for guiding novices like me but I still hope to get some guidance on the above product and issue related to my formulation. Formulating without a formal training could be disastrous.
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9 Replies
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Where did you get the formula from?
There’s no room for innovation for hospital products (at least for small manufacturers), so stick to proven formulas.Also, if I’m not mistaken, hospital products are often sterile filtered.
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We have done such formulations but that is a very high ethanol content. It will not allow any surfactant to foam, I have seen around 5% IPA in such formulations but not that high. Also HPMC will work better for a clear formulation, check Methocel 40-202. And don’t expect this to foam like a normal high foaming soap.
Plus stick to what Gunther has suggested as these formulations are used in the hospitals extensively. -
MurtazaHakim said:…1. Ethanol 99.9% : 350 ml2. Chlorhexidine Gluconate: 20 ml (0.5% w/v)3. Glycerol 98% : 3 ml…5. Lauramine Oxide: 10 gm….…The product did not produce any foam as is expected from any hand washing soap……this formulation felt like a mistake. The product which I referred for the above formulation is Hydrex Surgical Scrub produced by Ecolab…
…Formulating without a formal training could be disastrous.- The product you refer to contains only 2-5% ethanol, not 70%.- It also contains 4% chlorhexidine gluconate. Achieving this is impossible to do by using a 0.5% stock solution.- The reference product furthermore contains 10-20% glycerol, not just trace amounts.- Lauramine oxide is not a dialkylamine oxide. BTW MSDS states it at 2-5%…- Surgical soaps usually don’t produce foam or if, very little.- Your formulation is a mistake not because it’s not working the way you imagine it to work but because it is far from identical to a registered, safety and efficacy proven product and you simply don’t know if it works due to lacking performance testing. One could also say that your decision as a novice to attempt producing a surgical disinfectant/cleaning product is a mistake. Furthermore, you forgot for example to adjust pH, density, viscosity… My advice: For the sake of health, leave it be!- Correct, formulating such a product without formal training IS a disaster! I can only repeat myself: DON’T, JUST DON’T!PS I hope that your title ‘for hospital use’ doesn’t mean that you seriously plan on selling your products to hospitals! Please tell me that this is a joke. -
Chlorhexidine Gluconate used was 20 gm per 500 ml which is 4% w/v. I am unsure of the grade of chlorhexidine gluconate.Ignore 0.5% w/v reported in the previous post. 10-20% of glycerine seems to be a very high percentage. The reference product contains HEC. Is it only present as a rheology modifier ???
Hydrex was foaming just like any other liquid hand wash.
Can you provide any commercial grade of dialkylamine oxide ???
The most important factor is indeed the performance testing of the product without which the product has no commercial standing.
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Chlorhexidine Gluconate comes normally 20% solution
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Chlorhexidine Gluconate is available as a powder as well. Can we use the powder or it is advisable to use solution only ???
Secondly, is Chlorhexidine Gluconate Solution available only as 20% solution or there are other concentrations available ???
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20% is a reasonably easy to use concentration and IIRC dates back to the original product which was sold that way. Sure, you can use pure one but it takes more time and work to produce (smaller) batches.
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If I use Chlorhexidine Gluconate 20% solution I will have to use 5 times the quantity to achieve the same active percentage. Alcohol hand rubs have around 0.5 % w/v of CHG. If I use 20% solution I will have to use it at 2.5 % w/v instead.
CHG solution on addition to Alcohol renders the solution milky and subsequent addition of water again makes the solution clear. Will the pure CHG in powdered form dissolve if I use it at 0.5% w/v in hydroalcoholic solution ???
I came across a few studies by European researchers challenging the essentiality of CHG in hand rubs.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5598061/#__ffn_sectitle
Is it worth adding CHG to the product or omission of CHG does not affect the antiseptic performance ???
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Can we store Chlorhexidine Gluconate 20% solution in black IBC totes ???
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