Hand sanitizer has become one of the most important ingredients in our day-to-day life. Suddenly we come across a wide range of hand sanitizers, known and unknown brands. How do we select the right hand sanitizer from the lot?
Due to the present pandemic condition, the Medical authorities of respective countries have put forth a policy for determining the right compounding for alcohol based hand sanitizer products. Emphor DLAS, a leading life and analytical science solution provider explains more about your daily hand sanitizer. Research has been put for finding the best right compounding for hand sanitizers. The guidelines are given to the general public in the view of the pandemic. There is a shortage of branded sanitizers due to an increased demand which are normally manufactured under FDA guidelines. Due to the demand, medical authority like FDA has temporarily provided flexibility with respect to certain impurity levels for various brands. Many companies like distilleries and breweries have temporarily allowed their manufacturing units to produce hand sanitizers in response to the shortage. The FDA has released detailed protocol to follow while compounding for hand sanitizer. The protocol is intended to encourage a clean and safe working environment that will ultimately produce a clean and safe product for customers.
Ethanol, also known as Ethyl alcohol is produced using fermentation and distillation processes. Ethanol has been widely used and applied in fuels, antiseptics, household cleaning products and even some consumables goods. For decades they have been used in branded hand sanitizers under strict observation of FDA. The sudden emergency has caused to produce hand sanitizers which aren’t necessarily following the norms put forth by the medical authority. Many hand sanitizers available in stores are made with a considerably low alcohol level which is against the compounding protocol. The hand sanitizers that are less than 80% Ethyl Alcohol are cheaper than the 75% Isopropyl Alcohol based rubs, but do not disinfect or kill virus-spreading bacteria.
Ethyl Alcohol can include harmful chemicals, including gasoline and benzene, which is a known human carcinogen. These chemicals are normally absent in typical fermentation and distillation processes but may be present due to the manufacturing environment. Various reports based on scientific studies show excessive levels of acetaldehyde in certain fuel ethanol which become carcinogenic when in contact with tissues.
Isopropyl Alcohol is exclusively man-made. Pure Isopropyl alcohol evaporates instantly. It is a common and widely used disinfectant inside pharmaceutics, hospitals, cleanrooms and electronics. The compound is essentially 60- 90% alcohol and rest purified water. It is antimicrobial against bacteria, fungi, and viruses. The presence of water in Isopropyl alcohol is a critical factor in the severity as disinfectant. Inhaling Isopropyl alcohol can cause skin and lung irritant and accidental ingestion can have harmful effects on one’s health.
Denatured alcohol is ethanol with a chemical added to remove a compound, thus making it unfit or poisonous for human consumption. Denaturing is critical because there have been reports of adverse effects when used in injection to hand sanitizer. Most of the causality happened with young children. The alcohol should be denatured during production or at the compounding of hand sanitizer according to rules provided by FDA. The alcohol solution has bitter taste and discourages oral consumption.
An ideal hand sanitizer should contain:
- Alcohol (Ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution.
- Glycerin (Glycerol) (1.45% v/v)
- Hydrogen Peroxide (0.125% v/v)
- Sterile Distilled Water
Emphor DLAS recommends alcohol-based hand sanitizer that is formulated with 75% USP Grade Isopropyl Alcohol. Always check for certification which gives highest purity, potency, and accurate measurement.