4 replies to this topic

[Ashfaq Hussain]

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

[Dr.Khan]

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.

CEN standards: EN 1499 and EN 1500

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).

ASTM standards

• ASTM E-1174202
  Currently, 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.198
  The 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
• ASTM E-1838 (fingerpad method for viruses)205
  The 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
• ASTM E-2276 (fingerpad method for bacteria)207
  This 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.
• ASTM E-2613 (fingerpad method for fungi)208
  This method is for testing handwash or handrub against fungi. It is similar in design and application to the methods described above for working with viruses (E-1838)205 and bacteria (E-2276).207
• ASTM E-2011 (whole hand method for viruses)209
  In 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..

to read the full detail visit

WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care.

 

kind regards

Dr Humaid Khan

MD Halal International services

Australia

 

 

[Charles.C]

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.".

[GMO]

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.

[The Food Scientist]

Hi Ashfaq, did this supplier provide you with specifications for this handsoap? SDS?