Sanitize - Pakistan -WHO - FDA - USP - CDC - Compliant - 80 % Ethanol Based - Position Paper

To:

Date: 02-April-2020

HEALTH CARE – DISASTER MANAGEMENT ORGANIZATIONS – STAKE HOLDERS PAKISTAN Subject: INDIGINOUS DEVELOPMENT OF HAND SANITIZER For COVID-19 PANDEMIC Dear Sir We have worked on indigenous brand of Hand Sanitizer; which follows WHO Guidelines, USP and FDA guidelines for this emergency situation. We also have ample capacity to produce and supply to participate in this National Effort.

DESIGNED by RESEARCHERS, PHARMACISTS, SCIENTISTS and DOCTORS for HIGHEST GRADE PROTECTION for FRONT LINE HEALTH CARE WORKERS Compliant with Latest Guidelines For Effective Disinfection of Corona Virus During Pandemic, as per: World Health Organization (W.H.O) United States Pharmacopeia (U.S.P) U.S Food and Drug Administration (F.D.A) Center for Disease Control, USA (C.D.C) Sanitize products are designed keeping in mind to provide effective hand and surface sanitizer that is guaranteed to remove all viruses including the Wuhan COVID-19, the Corona Virus.

At ZAUQ we Integrates Innovative and emerging Technologies for Disruptive Transformation to Knowledge Economy, Dreaming of an Innovative Nation – Pakistan.

We have a corporate Innovation Lab at Pakistan’s First National Science and Technology Park, Located at NUST H12, Islamabad. INNONATION is striving to provide a platform for Researchers to sustainably be able To Innovate and commercialize Technologies for Global markets.

INNONATION is focused on projects for Health Care , Life Sciences, Pharmaceuticals Auto Identification, and Traceability ;Using Innovative Disruptive Technologies to address commercial and social problems.

At a time when the world is in the grip of an unprecedented pandemic – SARS COV2 (Novel Coronavirus) – and scientists and researchers are sparing no effort to ascertain remedies to this incurable disease; most important is to prevent spread.

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

WHY ALCOHOL BASED SANITIZER Global bodies ie WHO strongly recommends 70 to 80 percent ethanol v/v but not more than 90 percent; usual mechanism of action at this 70 to 80 percent are 3 points.... first is it How Ethanol Based Hand and Surface Sanitizers work against Viruses and other Germs 1) It Denatures outer protein coat of Germs 2) It dilutes the Lipid outer coat of germs 3) Ethanol with water has higher osmotic pressure so it creates pressure differential across the germ 4) This concentration provides enough contact time that is adequate to kill the germ 5) If this concentration is low it will be ineffective 6) If this is too high ie 90 percent or more, it will again be ineffective due to two reasons ie A) Very short contact time due to evaporation B) Second reason, it will coagulate only that portion of protein which comes in direct contact with it and this coagulant protein will seal (or protect ) the remaining germs behind it !

LATEST LITERATURE REVIEW ON ALCOHOL BASED HAND SANITIZER Background Hand sanitizer is a liquid or gel generally used to decrease infectious agents on the hands.

Alcohol-based hand sanitizer works against a variety of microorganisms and kills them.

As COVID-19 prevention measure patients, frontline workers and all people in effected area must wash their hands and make use of sanitizers as much as possible to wash away coronavirus contamination before touching eyes or mouth with contaminated hands which the coronavirus gets a chance to enter body.

COVID 19 There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally, including cases in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

significant impacts on healthcare systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the United States. On January 31, 2020, the Secretary of HHS determined that a public health emergency exists.

Hand hygiene is an important part of the U.S. response to COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom, before eating, and after coughing, sneezing or blowing one’s nose.

CDC Prior Recommendations The Centers for Disease Control (CDC) recommends washing hands with soap and water whenever possible because handwashing reduces the amounts of all types of germs and chemicals on hands. If soap and water are not available, using a hand sanitizer with a final concentration of at least 60% alcohol can help you avoid getting sick and spreading germs to others If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol.

Why? Many studies have found that sanitizers with an alcohol concentration between 60–95% are more effective at killing germs than those with a lower alcohol concentration or non-alcoholbased hand sanitizers 16,20. Hand sanitizers without 60-95% alcohol 1) may not work equally well for many types of germs; and 2) merely reduce the growth of germs rather than kill them outright. https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html AVAILABLE HAND SANITIZERS IN MARKET Hand Sanitizers have usually been a life style choice for a niche segment and the products designed were usually designed keeping in mind as a luxury product with gel like user experience and fragrance And they usually meet the minimum requirements of CDC or much lower Alcohol, Ethanol percentages as products being a life style products and not designed for an outbreak situation or medical grade, high grade protection.

Ethanol Based Formulation Guidelines references

GUIDE LINES FROM WHO , US FDA, USP 1. United States Pharmacopeia (USP) A Guideline was issued by USP about Alcohol-Based Hand Sanitizer During COVID-19 Pandemic On March 18, 2020 for which latest revision was released on 25th march 2020

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

Document is available at https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19handrub.pdf (Also Attached Latest version) Page 2 of 3; refers to Formulation 1 and 2 were developed based on WHO recommendations.

Referred at: https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf i-e Formulation 1, 2 on Page 2 are;

Formulation 1: Ethanol 80% v/v

2. US Food and Drug Administration (US FDA) A Guideline was issued by FDA about Alcohol-Based Hand Sanitizer Products During the Public Health Emergency On March 14, 2020 for which latest revision was released on 27th March 2020 Document is available at https://www.fda.gov/media/136118/download (Also Attached Latest version)

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

WHO Recommendations: https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

US FDA Recommended Formulation on Page 6 of 11; Page 6 of 11; refers to Formulation developed based on WHO recommendations. i-e

Formulation referred by FDA based on WHO: Ethanol 80% v/v

3. World Health Organization (WHO) A Guideline was issued by FDA about Alcohol-Based Hand Sanitizer Products During the Public Health Emergency On March 14, 2020 for which latest revision was released on 27th March 2020 Document is available at https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf (Also Attached Latest version) WHO Recommended Formulation on Page 4 of 9; Page 4 of 9; refers to recommended Formulation

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

Formulation referred by FDA based on WHO: Formulation 1: Ethanol Antiseptic 80% Ethanol 80% v/v

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management.

Kindly help us promote and reach and raise awareness to be able to provide maximum quantities of these products to Front Line Workers.

Thanking in anticipation Warmest Regards M. Rizwan Buttar Chief Innovation Officer +923214777001 rizwan@zauq.com

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This document is in progress stage, errors, omissions suggestions

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

USAGE INSTRUCTIONS Apply limited quantity as per instructions Apply only limited but adequate number of times as prescribed Apply only on targeted surface Keep rubbing at least 30 seconds for adequate contact time Keep away from fire Keep out of reach of children Keep storage in room temperature below 30 degree centigrade Use within 3 years if unopened In case of accidental ingestion or allergy, seek medical support urgently

CAUTIONS Don't apply excessive quantity Don't apply continuously Don't mix any other ingredient Not to apply internally or on mucosa or eye Not for injection Not for ingestion Not for eating or drinking Not for inhalation Not to be stored in a place exposed to sun light or extreme temperature

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk

Santize project is dedicated to the Brave Ones; the FRONT LINE WORKERS who are fighting this Pandemic including but not limited to Healthcare, law Enforcement, Laboratories, Airline, Transport, Banks, Telcos, Border protection, Solid waste and Wastewater management. https://www.sanitize.pk/ do@santize.pk