miércoles, 12 de agosto de 2020

Sanitizer Technology

 

Sanitizer Technology

Posted on May 22, 2020 by George Deckner

Prospector Publications

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Photo of a woman using hand sanitizer - Learn more about sanitizers

The Global Hand Sanitizer Market size was valued at $919 million in 2016 and is expected to reach $1,755 million by 2023 (1). These figures however were calculated before the current health crisis and should be substantially higher in the future.

A hand sanitizer is an antiseptic solution used to reduce the concentration of microorganisms on skin. Over-the-counter antiseptics are classified by the FDA as washes and rubs and are regulated as OTC drugs by the FDA (2). They must be registered and produced in FDA approved facilities. Disinfecting cleansers are meant for treating hard, inanimate surfaces. They are regulated and must be registered with the Environmental Protection Agency (EPA).

FDA classifications of antiseptics

  • Wash products (also known as antibacterial soaps) are intended for use with water and are rinsed off after use, and include hand washes /soaps and body washes. The FDA position is that these products have not yet been shown to be more effective at preventing illness than plain soap and water and there currently are no approved actives for this application FDA supports the CDC’s recommendation to use plain soap and water to wash your hands.
  • Rubs are leave-on products, or hand “sanitizers,” as well as antiseptic wipes. These products are intended to be used when soap and water are not available, and are left on and not rinsed off with water. Rubs are further classified by the FDA into health care and consumer antiseptics. Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. Consumer antiseptics are primarily used in the home, schools, daycares or other public settings.

According to the EPA (Environmental Protection Agency), the following are standard definitions of clean, sanitize, and disinfect (3).

  • Clean – The process that physically removes debris from the surface or area by scrubbing, washing, and rinsing. It may be accomplished with soap or detergent and water.
  • Sanitize – A product that kills 99.9% of germs identified on its label. Sanitizers are used to reduce, but not necessarily eliminate microorganisms from the inanimate environment levels considered safe as determined by public health codes or regulations.
  • Disinfect – A product that kills nearly 100% of germs identified on its label. Disinfectants are used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria, but not necessarily their spores. There are two major types of disinfectants: hospital and general use. Hospital disinfectants are the most critical to infection control while general disinfectants are typically used in households, swimming pools, and water purifiers.

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Hand sanitizers are included in the OTC category Antiseptic Hand Wash or Healthcare Personnel Hand Wash category for products “designed for frequent use” and intended to “reduce the number of transient micro-organisms on intact skin.” This category also includes antimicrobial hand washes, which serve the same purpose as hand sanitizers and differ only in that they require water for use.

The 1994 tentative final monograph lists topical antimicrobial ingredients based on scientific data submitted to the FDA advisory review panel to determine their safety and efficacy. The ingredients were placed into 3 categories (4)

  • Category I: GRASE (generally recognized as safe and effective)
  • Category II: not GRASE
  • Category III: cannot determine if safe and effective; more data needed

The only category I GRASE actives are Ethanol 60-95% and PVP-Iodine 5-10%. Note, PVP-Iodine is brown in color and will stain the skin a light brown color. Category III actives include Triclosan, Triclocarban, Benzalkonium chloride, Benzethonium chloride and Parachlorometaxylenol. All potential active ingredients for skin antiseptics, were placed into Category III because the FDA has concluded that they lack either safety or efficacy data sufficient for GRASE classification in hand sanitizers. The monograph currently is only tentative, and manufacturers can market hand sanitizers based on Category III ingredients. However, they are required by the FDA to submit further safety and/or efficacy data to prevent these ingredients from being excluded in the Final Monograph as GRASE active ingredients.

Consumer antiseptic hand sanitizers are available as gels, non-aerosol foams, wipes and sprays. The most popular forms are gels followed by non-aerosol foams however the fastest growing form is foam.

Formulating hand sanitizers

The most common type of commercial hand sanitizers are gel formulations which use 60-70% Ethanol thickened with ~.4% Acrylates/C10-30 Alkyl Acrylate Crosspolymer neutralized using ~.2% Aminomethyl Propanol (AMP). Other suitable thickeners include Carbomer, Acrylates/Vinyl Isodecanoate Crosspolymer, Polyacrylate Crosspolymer-11, Polyacrylate Crosspolymer-6, Polyquaternium 37, Hydroxypropylcellulose, and Hydroxypropyl Guar. Non-aerosol foam formulations are designed to be dispensed using pump foamer packages and are comprised of 60-70% Ethanol and 2-5% surfactant. Choice of the surfactant however is very critical since most will not produce a stable foam due to the high alcohol content. The best types of surfactants for this application are silicone based copolyols however there are numerous patents covering this application.

References

  1. https://www.alliedmarketresearch.com/hand-sanitizer-market
  2. https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps
  3. https://www.epa.gov/
  4. https://www.cosmeticsandtoiletries.com/regulatory/region/northamerica/60657047.htm

 

 


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GREEN CHEMICALS

The Green Seal certification is granted by the organization with that name and has a great number of members contributing with the requirements to pass a raw material or a chemical product as "green". Generally for a material to be green, has to comply with a series of characteristics like: near neutral pH, low volatility, non combustible, non toxic to aquatic life, be biodegradable as measured by oxygen demand in accordance with the OECD definition.
Also the materials have to meet with toxicity and health requirements regarding inhalation, dermal and eye contact. There is also a specific list of materials that are prohibited or restricted from formulations, like ozone-depleting compounds and alkylphenol ethoxylates amongst others. Please go to http://www.greenseal.com/ for complete information on their requirements.
For information on current issues regarding green chemicals, see the blog from the Journalist Doris De Guzman, in the ICIS at: http://www.icis.com/blogs/green-chemicals/.
Certification is an important — and confusing — aspect of green cleaning. Third-party certification is available for products that meet standards set by Green Seal, EcoLogo, Energy Star, the Carpet & Rug Institute and others.
Manufacturers can also hire independent labs to determine whether a product is environmentally preferable and then place the manufacturer’s own eco-logo on the product; this is called self-certification. Finally, some manufacturers label a product with words like “sustainable,” “green,” or “earth friendly” without any third-party verification.
“The fact that there is not a single authoritative standard to go by adds to the confusion,” says Steven L. Mack M.Ed., director of buildings and grounds service for Ohio University, Athens, Ohio.
In www.happi.com of June 2008 edition, there is a report of Natural formulating markets that also emphasises the fact that registration of "green formulas" is very confused at present, due to lack of direction and unification of criteria and that some governmental instittion (in my opinion the EPA) should take part in this very important issue.