Pharma-grade ethanol: Thinking beyond fuel-grade ethanol

January 10, 2022 |

By Mr. Ghanshyam Deshpande, President, Center of Innovation and Applied Technologies, Praj Industries

Special to The Digest

A sudden need for pharma-grade Ethanol

With the backdrop of the Covid-19 pandemic, the World Health Organization has issued guidelines on sanitization practices stating frequent use of sanitizers, disinfectants to prevent virus infection. Governments & various health agencies ran global public awareness programs on the importance of following proper sanitization techniques. This led to soaring demand for hand sanitizers, disinfectants, and other sanitization products containing ethanol. This resulted in an exponential increase in the demand for pharmaceutical-grade ethanol. In fact, there have been global shortages due to the huge demand and supply gap of pharma grade ethanol since the pandemic. To meet the demand posed by the pandemic, distilleries (ethanol plants) rose to the occasion by ramping up the production of ethanol. Enforced lockdowns caused a reduction in the number of vehicles on the road resulting in decreased fuel usage. This caused the world to experience a drying up of fuel demand. Demand for ethanol used in the blending with gasoline also decreased. Plants producing fuel ethanol have thus tried to survive the sudden drop in fuel demand by exploring product diversification. While some plants have idled, some throttled up the production capacity of ethanol.

Pharma grade ethanol consumption is increased from 16240 million liters (Global ethanol production 116000 million liters) from past 2019 to 18560 million liters in 2020 (Global ethanol production 99800 million liters). Some producers of corn-based fuel ethanol have switched their outputs to the pharma-grade alcohol needed for hand sanitizers and other pharmaceutical products containing ethanol.

What is Pharma grade ethanol?

Pharma grade ethanol is high purity alcohol with stringent specifications.  It is used in a variety of manufacturing processes in the pharmaceutical industry like sanitizers, topical disinfectants, solvents, and preservatives in pharmaceutical preparation and many other pharmaceutical applications. The primary impurity of concern in pharma-grade ethanol is acetaldehyde. Acetaldehyde is “possibly carcinogenic to humans” according to the International Agency for Research on Cancer (IARC). Acetaldehyde along with Acetal limits have been set at 10 ppm in various pharmacopeia like British Pharmacopoeia, European Pharmacopoeia, and the United States Pharmacopeia (USP). Other congeners like methanol, as per USP, should not be more than 200 ppm, benzene not more than 2 ppm and total congeners put together not more than 300 ppm as per the United States Pharmacopeia (USP).

With the sudden rise in the demand of pharma-grade ethanol, and considering its stringent specifications there is a need for advanced technology.

Requisites for pharma-grade ethanol

To cater to the growing demand for pharma–grade ethanol, the need is

  • To move at “warp speed”.
  • Upgrade the production process to produce pharma-grade ethanol thereby maximizing profits
  • Easy and fast switch between fuel and pharma-grade ethanol depending upon supply and demand.
  • Flexibility to produce fuel ethanol and pharma-grade ethanol from the same facility.
  • Technology that produces pharma-grade ethanol at low CAPEX & OPEX.

The advanced technology solution catering to all these demands is the EcoSmart technology.

Praj’s Ecosmart Technology

Being a leader in the ethanol industry, Praj holds proprietary technology which not only converts existing fuel ethanol plants to pharmaceutical-grade ethanol plants but also maximizes profits. Existing ethanol plant systems can be re-engineered and thus upgraded to produce pharmaceutical-grade ethanol. This leads to an easy and fast switch between fuel and pharma-grade ethanol. The same facility can produce fuel and pharma-grade ethanol simultaneously.

With the havoc of the pandemic around, Praj came at the forefront with its proprietary Ecosmart technology. We supported the existing players in the fuel ethanol industry to strive for the business with dried fuel ethanol demand and gain a share of social responsibility to overcome the pandemic. These facilities can easily be upgraded to pharma-grade ethanol meeting specifications of United States Pharmacopeia (USP), European Pharmacopoeia, and British Pharmacopoeia, by adopting Ecosmart technology.

Praj EcoSmart technology consists of four steps:

  • Feedstock Pretreatment
  • Controlled Low Boiler separation
  • Controlled Heavy Boiler Separation
  • Product finishing
  1. Feedstock Pre-treatment:

Pre-treatment of the feedstock is required to stabilize 190 proof or 200 proof ethanol. It is the most important step and key to effective impurity separation. Congeners like Acetal keep on changing their form on the application of heat and thus making the separation very difficult. Pre-treatment stabilizes the congeners like acetal.

  1. Controlled Low Boiler separation & Controlled Heavy Boiler Separation:

In conventional technologies, while carrying out the separation process, a three-phase separation takes place in the presence of water viz. water, ethanol, and congeners. Components like n-propanol, iso-propanol, butanol, etc. being high boilers make the separation process difficult.

While, EcoSmart technology operates in the absence of water, with a two-phase separation viz. ethanol and congeners. Congeners are divided into high boilers and low boilers. Only 2 columns viz. high boiler column (HB) and low boiler column (LB) are used for congener separation to achieve the desired specification of pharma-grade ethanol. Congeners like aldehydes, acetal, heavy alcohols can be effectively separated.

  1. Product Finishing:

Product finishing ensures the separation of impurities which are generally not measured on gas chromatography and improves the smell and taste of the final product. It also helps to achieve the desired alcohol concentration according to pharma alcohol standards.

Benefits of EcoSmart technology

  • EcoSmart technology provides the flexibility to alter the four steps stated above in simple ways to obtain desired grades of ethanol.
  • It can be easily retrofitted in an existing fuel ethanol plant.
  • It can be designed for varying feed compositions.
  • Helps obtain colorless, transparent, ethyl alcohol concentration of 99.97 v/v%.
  • A combined concentration of 7 ppm for acetaldehyde and acetal as against the acceptable limit of 10 ppm can be achieved.
  • Methanol concentration as low as 0.5 ppm can be obtained.
  • Nil to max 1 ppm acidity in terms of acetic acid can be obtained.
  • Our technology can be energy integrated with the existing facility in such a way that additional thermal energy or steam consumption for EcoSmart can be minimized. This helps in reducing the overall carbon intensity of the existing ethanol plant.
  • While performing impurity separation, due to effective pre-treatment, Ecosmart consumes 30 % lower thermal Energy and 40 % lesser water than the conventional process.
  • Flexibility to produce various grades of ethanol with the facility of one product at a time or simultaneously producing multiple products.
  • An important feature of this technology is its simplicity of operation thereby does not require a specific skill of operation. For example, in the conventional process, producing beverage ethanol is an art and requires a specific skill set and training. EcoSmart technology has converted this art into science and made it extremely easy to operate and no additional resource is required for its operation. Present fuel ethanol operators can easily operate this plant.
  • Any fuel ethanol plant can easily be converted to a high-value ethanol plant in a very short period and with minimal investments.

Praj has built around 20 pharma-grade ethanol plants across the globe and more than 150 plants for beverage-grade ethanol. At present we are building about 6 plants in North America that can produce various grades of ethanol including Pharma & Beverage grade. Our plant in Hungary is a live testimony of the successful product diversification and functionality for the past 8 years.

Hungary: Product Diversification

EcoSmart Technology plant supplied by Praj to one of the prime market leaders in Hungary is successfully producing different grades of ethanol from fuel ethanol as feed since 2013. Diversification was requested by the plant owner which initially had the corn to ethanol set up at the facility. The addition of the EcoSmart module with a capacity of 12 MGPY provided product diversification by producing high-grade ethanol. All the heavy boilers like n-propanol / n-butanol and iso-butanol were separated to levels of more than 99 % of their content in the feed. The facility makes a very low consumption of steam for the conversion of fuel to USP Grade Ethanol.

Beyond fuel grade

Product diversification can be obtained through EcoSmart technology by switching to various options other than fuel ethanol. Leveraging this technology would not only provide benefits to the environment but also provide socio-economic benefits by creating job opportunities, generating additional revenues, and decreasing the import bills for the required products.

Our Pharma-grade ethanol facility installed in 2021 for a leading company in the U.S.

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