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Hand wipe disinfection: 30% alcohol may be sufficient
Old 04-15-2020, 06:41 PM   #1
gone traveling
 
Join Date: Dec 2010
Posts: 538
Hand wipe disinfection: 30% alcohol may be sufficient

We may have lucked out on this one. Prepare for the worst and hope for the best.

Note that the official government regulations still require 80% ethanol or 75% propanol.

BUT a few days ago, a study using the actual SARS-CoV-2 virus was pre-released. It concludes that 30% v/v of either ethanol or isopropyl alcohol achieves sufficient disinfection in 30 seconds. This is preliminary, and they may have used an inadequate test method. Review will determine.


Six weeks or so ago, I pointed out a Jan2020 survey study on various disinfecants against various pathogens. It showed that to disinfect MERS and SARS in a 30 second time frame, you need to use upwards of 78% alcohol (depending on the type of alcohol).

https://sci-hub.tw/10.1016/S0140-6736(20)30566-3
Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents
G. Kampf JAN2020


On 23MAR20 the FDA published interim regulations on manufacturing hand wipe disinfectant. Those regs echo that study. The FDA adopted the "modified" WHO recipes (their "original" recipes were shown to be deficient in certain respects, not meeting a particular European standard).

Note: Both the "original" and "modified" WHO document have two "formulas."
Formula I is for ETHANOL.
Formul II is for ISOPROPANOL.


WHO Guidelineson Hand Hygiene in Health Care: a Summary
© World Health Organization 2009
WHO/IER/PSP/2009.07
I don't have a direct URL for that at hand.

and the "original" version:
Guide to Local Production:
WHO-recommended Handrub Formulations
Rev APR2010

The only difference in the "modified" recipes is they recommend reducing the glycerol from 1.45% to half that, and using wt/wt instead of v/v -- the resulting percentage numbers happen to be the same, which is a source of confusion. But wt/wt creates a higher alcohol concentration than v/v.


CURRENT LAW: FDA DOCUMENT PUBLISHED 23MAR20:
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
Immediately in Effect Guidance for Industry

Additional copies are available from the FDA webpage titled “Coronavirus Disease 2019 (COVID-19),” available at

https://www.fda.gov/emergency-prepar...-2019-covid-19

and from the FDA webpage titled “Search for FDA Guidance Documents” available at https://www.fda.gov/regulatory-infor...ance-documents. You may also send an e-mail request to druginfo@fda.hhs.gov to receive a copy of the guidance. Please include the document number FDA-2020-D-1106 and complete title of the guidance in the request.

>
Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms7 that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:

1. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:8

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20;

or Isopropyl Alcohol (75%, v/v)

in an aqueous solution.9

b. Glycerol (1.45% v/v).10

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

FOOTNOTES:

8 The 1994 TFM is available at https://www.gpo.gov/fdsys/pkg/FR-199...l/94-14503.htm. WHO’s recommendations, titled “Guide to Local Production: WHO-recommended Handrub Formulations,” are available at https://www.who.int/gpsc/5may/Guide_...Production.pdf.

9 Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20;

isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol.

10 Although WHO’s recommended formulation includes glycerol 1.45% (v/v), reports indicate that glycerol negatively impacts effectiveness of isopropyl alcohol (https://www.ncbi.nlm.nih.gov/pubmed/28670452), and reports studying the effectiveness of WHO’s formulation have suggested a reduction from 1.45% to 0.725% (https://www.ncbi.nlm.nih.gov/pubmed/23388358/).
>


A few days ago, a study using the actual SARS-CoV-2 was pre-released. It concludes that 30% v/v of either ethanol or isopropyl alcohol achieves sufficient disinfection in 30 seconds. It notes that you have to actually keep it wet for 30 seconds. Also, you cannot "gunk it up" with emoluents or aloe.


https://wwwnc.cdc.gov/eid/article/26/7/20-0915_article
CDC Emerging Infectious Diseases ISSN: 1080-6059
Volume 26, Number 7—July 2020
Dispatch
Inactivation of Severe Acute Respiratory Syndrome Coronavirus 2 by WHO-Recommended Hand Rub Formulations and Alcohols
Annika Kratze et al

>
WHO’s guidelines for hand hygiene in healthcare suggest 2 alcohol-based formulations for hand sanitization to reduce the infectivity and spread of pathogens (6). WHO’s recommendations are based on fast-acting, broad-spectrum microbicidal activity, along with accessibility and safety. The original WHO formulations failed to meet the efficacy requirements of European Norm 1500 in previous tests (7). However, Suchomel et al. (8) suggested modified versions with increased concentrations of ethanol: 80% (wt/wt) (85.5% [vol/vol]; formulation I), or isopropanol, 75% (wt/wt) (81.3% [vol/vol]; formulations II). Later, they complemented these by reducing the glycerol concentrations (9).

We previously showed that these modified WHO formulations were able to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV; 10), which are related to SARS-CoV-2. Current recommendations to inactivate SARS-CoV-2 were translated from findings of other coronaviruses (11).

To evaluate whether these alcohol-based disinfectants also effectively inactivate SARS-CoV-2, we tested different concentrations of the original and modified WHO formulations I and II (6,9), ethanol, and 2-propanol for virucidal activity.

The Study

We propagated SARS-CoV-2 (SARS-CoV-2/München-1.1/2020/929) on VeroE6 cells
SNIP

Original WHO formulation I consists of 80% (vol/vol) ethanol, 1.45% (vol/vol) glycerol, and 0.125% (vol/vol) hydrogen peroxide. Original WHO formulation II consists of 75% (vol/vol) 2-propanol, 1.45% (vol/vol) glycerol, and 0.125% (vol/vol) hydrogen peroxide.

The modified WHO formulation I used in our study consists of 80% (wt/wt) ethanol, 0.725% (vol/vol) glycerol, and 0.125% (vol/vol) hydrogen peroxide.

The modified isopropyl-based WHO formulation II contains 75% (wt/wt) 2-propanol, 0.725% (vol/vol) glycerol, and 0.125% (vol/vol) hydrogen peroxide (9). We also prepared ethanol (CAS 64–17–5) and 2-propanol (CAS 67–63–0) in vol/vol dilutions for investigation.

We performed virucidal activity studies by using a quantitative suspension test with 30 s exposure time (6).
SNIP

the modified formulation II [ ISOPROPANOL ] of 75% (wt/wt) 2-propanol had a log10-reduction of >5.9.

Dilution >30% (vol/vol) also resulted in complete viral inactivation (Figure 1, panel D).

SNIP

We also investigated the susceptibility of SARS-CoV-2 against the active components of the WHO-recommended formulations, which are also the active ingredients of commercially available hand disinfectants.

Ethanol (Figure 2, panel A) and 2-propanol (Figure 2, panel B) were able to reduce viral titers to background levels in 30 s with RFs of between 4.8 and ≥5.9.

Furthermore, we noted that a concentration of >30% (vol/vol) ethanol or 2-propanol is sufficient for complete viral inactivation (Figure 2).

Conclusions

We found that SARS-CoV-2 was efficiently inactivated by WHO-recommended formulations, supporting their use in healthcare systems and viral outbreaks. Of note, both the original and modified formulations were able to reduce viral titers to background level within 30 s.

In addition, ethanol and 2-propanol were efficient in inactivating the virus in 30 s at a concentration of >30% (vol/vol).

Alcohol constitutes the basis for many hand rubs routinely used in healthcare settings. One caveat of this study is the defined inactivation time of exactly 30 s, which is the time recommended but not routinely performed in practice. Our findings are crucial to minimize viral transmission and maximize virus inactivation in the current SARS-CoV-2 outbreak.
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Old 04-16-2020, 02:49 PM   #2
gone traveling
 
Join Date: Dec 2010
Posts: 538
One thing I want to research is the details of "suspension tests" vs the other types of tests. Another is which of the biological carriers used in tests. What test type & carrier is the best simulant of stuff coming from the nose & mouth?

www.viroxylabs.com
BLOG POST:
https://www.viroxylabs.com/viroxy-bl...uropean-norms/
Suspension Test And Carrier Test For Disinfectants According To European Norms
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