Reference to evaluate the quality of Antimicrobial hand wash soap
Hello everyone,
We are working new supplier of hand wash soap (Anti-microbial hand wash soap). We need to set target of soap quality. As per FDA guidelines will helps or other.
The sample tested physically, it looks fine. Lab tested i.e pH, 7.65, Moisture% 72, and test organisms
- Bacterial culture count E. Coli (before contact) log10/mL 8.0
- Bacterial culture count E. Coli (after contact) log10/mL 3.0
- Reduction log 5.0
Looking for specification with reference to evaluate the quality of soap,,
Regards,
Ashfaq Hussain
Hello Ashfaq
Following test method may help you in establishing the quality parameters to test the effectiveness of the antimicrobial properties of your soap samples
10.1.1. Methods to test activity of hygienic handwash and handrub agents
The following in vivo methods use experimental contamination to test the capacity of a formulation to reduce the level of transient microflora on the hands without regard to the resident flora. The formulations to be tested are hand antiseptic agents intended for use by HCWs, except in the surgical area.
In Europe, the most common methods for testing hygienic hand antiseptic agents are EN 1499200 and EN 1500.201Briefly, the former standard requires 12–15 subjects, and the latter (in the forthcoming amendment) 18–22, and a culture of E. coli. Subjects are assigned randomly to two groups where one applies the test formulation and the other a standardized reference solution. In a consecutive run, the two groups reverse roles (cross-over design).
If an antiseptic soap has been tested according to EN 1499,200 the mean log10 reduction by the formulation must be significantly higher than that obtained with the control (soft soap). For handrubs (EN 1500), the mean acceptable reduction with a test formulation shall not be significantly inferior to that with the reference alcohol-based handrub (isopropyl alcohol or isopropanol 60% volume).
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ASTM E-1174202Currently, handwash or handrub agents are evaluated using this method in North America. The efficacy criteria of the FDA’s Tentative Final Monograph (TFM) are a 2-log10 reduction of the indicator organism on each hand within 5 minutes after the first use, and a 3-log10 reduction of the indicator organism on each hand within 5 minutes after the tenth use.198The performance criteria in EN 1500 and in the TFM for alcohol-based handrubs are not the same.48,198,201Therefore, a formulation may pass the TFM criterion, but may not meet that of EN 1500 or vice versa.203 It should be emphasized here that the level of reduction in microbial counts needed to produce a meaningful drop in the hand-borne spread of nosocomial pathogens remains unknown.48,204
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ASTM E-1838 (fingerpad method for viruses)205The fingerpad method can be applied with equal ease to handwash or handrub agents. When testing handwash agents, it can also measure reductions in the levels of viable virus after exposure to the test formulation alone, after post-treatment water rinsing and post-rinse drying of hands. This method also presents a lower risk to subjects because it entails contamination of smaller and well-defined areas on the skin in contrast to using whole hands (see below). The method can be applied to traditional as well as more recently discovered viruses such as caliciviruses.206
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ASTM E-2276 (fingerpad method for bacteria)207This method is for testing handwash or handrub against bacteria. It is similar in design and application to the method E-1838205 described above for working with viruses.
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ASTM E-2613 (fingerpad method for fungi)208
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ASTM E-2011 (whole hand method for viruses)209In this method, the entire surface of both hands is contaminated with the test virus, and the test handwash or handrub formulation is rubbed on them. The surface of both hands is eluted and the eluates assayed for viable virus..
kind regards
Dr Humaid Khan
MD Halal International services
Australia
Hello everyone,
We are working new supplier of hand wash soap (Anti-microbial hand wash soap). We need to set target of soap quality. As per FDA guidelines will helps or other.
The sample tested physically, it looks fine. Lab tested i.e pH, 7.65, Moisture% 72, and test organisms
- Bacterial culture count E. Coli (before contact) log10/mL 8.0
- Bacterial culture count E. Coli (after contact) log10/mL 3.0
- Reduction log 5.0
Looking for specification with reference to evaluate the quality of soap,,
Regards,
Ashfaq Hussain
Hi Ashfaq,
I assume to be used in a food manufacturing facility.
As a first priority, IMO, it should be documented as suitable for "intended purpose/location.".
I seem to remember reading something when I first started in the food industry to say that washing hands with normal, not antimicrobial soap gives sufficient log reductions and much like that, I suspect the method is more important than the product.
The ultimate would be to trial it and see your micro results? But of course as Charles says, make sure it's suitable for food manufacturing and doesn't contain known (listable) allergens.
Hi Ashfaq, did this supplier provide you with specifications for this handsoap? SDS?