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November 2021 Issue 199-Food and Beverage
Gasworld US Edition, Volume 59, Issue 11 (November)-LNG
Author: Rob Cockerill, Global Editor-in-Chief2021-11-10T06:00:00 00:00
If we accept that continued dialogue about access to medical oxygen is a prerequisite during the pandemic, and if it is not the lessons learned from the oxygen crisis of the past 18 months, can we still argue about its purity and purity? Accessibility itself?
Facts have proved that many lessons can be learned from this pandemic, many of which are related to the oxygen supply chain. In the course of this series of articles, a series of topics were raised, especially the difference between medical-grade liquid oxygen produced and oxygen produced on-site through a dedicated pressure swing adsorption (PSA) system.
Another theme is the theme of industrial grade oxygen and medical grade oxygen. Especially based on the experience of the past six months, when it seems that almost any grade of oxygen can meet India's unsatisfactory demand, people may argue whether there is a problem with the "taboo" topic of medical oxygen purity. Have the barriers in our traditional understanding of what medical oxygen is or should be broken?
To better integrate the discussion here, let us first review what medical oxygen is and how it is produced.
Oxygen is one of the core air gases, most of which are produced by the air separation process in the ASU (Air Separation Unit). Generally speaking, the surrounding air is composed of 78% nitrogen, 21% oxygen (approximately), 1% argon and other components (such as rare gases such as krypton, neon, and xenon). ASU absorbs a large amount of atmospheric air and decomposes it into individual components (oxygen, nitrogen, argon) through several separation and distillation stages.
Oxygen produced by cryogenic processes is usually produced with a purity greater than 99%, so it can be used in basically all applications, including for medical purposes. However, medical oxygen is regarded as a kind of medicine or medicinal product in the field of healthcare.
The oxygen produced by air separation can be used as medical oxygen without any additional purification steps. The air separation process itself removes contaminants to levels that are generally lower than required to meet medical oxygen specifications. Although some air separation facilities may transfer part of the oxygen they produce to dedicated medical oxygen tanks, this is not a common practice and is not necessary; the oxygen produced by air separation can be used as medical oxygen in terms of the nature of the process. use.
Many air separation facilities produce oxygen into a public tank, and then use the testing equipment in the facility to verify that the product meets the specifications for its intended use. In the case of medical oxygen, the test equipment in the facility is also used to generate test results, allowing qualified personnel to use the product as acceptable medical oxygen. In order to be able to sell medical oxygen, the factory must obtain the required permits and ensure that strict specifications are met-but not only the factory must go through these process steps. Supervision applies to the entire supply chain, from production to supply to patients, whether through liquid distribution or gas cylinder distribution, to ensure that no contaminants enter the final qualified product. This may represent some kind of red tape, but it is still the basis for the safe use of oxygen by patients104.
There are always areas or risks that need to be managed, whether in the transmission process or in relation to the customer's process, such as in the case of backward contamination. Even with the use of a PSA system, precautions are needed to ensure that no accidental pollutants are introduced, whether it is due to poor or deteriorated local air quality, poor maintenance, or even exhaust emissions from parked vehicles that are too close to the air intake; the latter example may Just an example that those who are far from the subject would not consider before. Gasworld also understands the industry. Through its various associations and regulatory agencies, it has had to do a lot of work in recent years to prove to the regulatory agencies that the cylinders used to supply medical oxygen will not add metal contaminants to the gas.
The issue of these practices or required permits became the focus in April 2020 at the peak of the first wave of Covid-19 sweeping the world. This is the development in India on April 8th. According to data from the Johns Hopkins University Center for Systems Science and Engineering (CSSE), less than 6,000 confirmed Covid-19 cases and 178 deaths were recorded at that time. Many feelings may be groundbreaking paths that others will follow in the coming weeks.
According to gasworld, the Indian government allows industrial oxygen manufacturers to temporarily manufacture and sell gas for medical purposes because the country continues to expect its coronavirus cases to escalate and result in hospitalization105. This is largely a balance of risks-the risk of providing potentially impure or damaged products and the risk of not providing products at all. All things considered, the risk is of course borne by the patient, so a completely complicated decision was made-it seems that the infection rate and mortality rate at the time, coupled with the challenge of getting enough oxygen, eventually forced the government to take action.
It is understood that the proposal was put forward by the All India Industrial Gas Manufacturers Association (AIIGMA) to ensure the availability and supply of medical oxygen throughout the country. The grant was issued by the General Administration of Health Services (Government of India) on April 8, and basically enables all industrial oxygen manufacturers in the country to obtain a license to sell products for medical purposes within 24 hours of receiving an application.
Just a few weeks later, in Europe, the European Medical and Medical Quality Authority (EDQM) will also initiate a special public consultation to discuss how best to include the 98% pure oxygen obtained through the two-stage concentrator in the European Pharmacopoeia Within 106.
This development is largely due to the increased demand for medical oxygen during the current coronavirus pandemic, but also due to technological advancements since the publication of the last monograph, especially the two-stage pressure swing adsorption (PSA) oxygen production The rise of the machine.
The European Pharmacopoeia currently includes two monographs on oxygen, the first is oxygen (0417), and the second is oxygen (93%) or oxygen 93 (2455). Oxygen (0417) was drafted more than 50 years ago and covers the oxygen produced by cryogenic distillation. The minimum oxygen content specification is 99.5%. Oxygen 93 (2455) was first published in Europe in 2010 and covers the oxygen produced by a concentrator that uses a PSA system to remove nitrogen from the ambient air.
When the latter was published, the equipment available on the market used a single-stage adsorption process that did not remove any argon from the air being processed. Since then, progress has been made in the design of the PSA oxygen generator, and companies such as Novair are now producing two-stage PSA equipment capable of producing 98% of the nominal oxygen content. This prompted us to decide to write a new monograph "Oxygen (98%) (3098)", especially because the ongoing Covid-19 pandemic at that time increased the world's demand for oxygen by as much as 10 times.
Twelve months later, as the country struggles to cope with the deadly second wave of Covid-19, the emergence of Delta variants, and severe medical oxygen shortages, we will all continue to see desperate scenes across India.
With the daily confirmed Covid-19 cases exceeding 250,000 and the rapid escalation, it was revealed on April 19 (2021) that India will implement new restrictions to manage the application of oxygen supply and prioritize its use for medical purposes107 .
Several states in India have experienced oxygen shortages, and the government quickly announced that oxygen supply will be limited to nine industries. From April 22, industrial oxygen supply will be limited to entities involved in refilling steel cylinders, pharmaceutical departments, steel plants, oil refineries, wastewater treatment, food and water treatment, nuclear power facilities, and continuous production sites that must keep processes running. In essence, daily work is only an essential industrial use, and medical oxygen is provided first.
It has just been more than a year since India broke ground as the first country to temporarily allow industrial oxygen producers to manufacture and sell medical gases. But the story will continue to develop rapidly, and the subsequent crisis in securing and distributing oxygen supply will further question the paradigm shift between industrial oxygen and medical oxygen.
Just four days later, on April 23, gasworld revealed that India is calling on the international industrial gas community to provide emergency help to meet its oxygen demand108. It is understood that the Indian High Commission in the Middle East, Europe and Asia are all seeking help from natural gas companies and natural gas associations.
According to Saket Tiku, President of AIIGMA, India’s demand for medical oxygen has increased from the normal 800 tons per day to an unheard high of about 3,000 tons at the peak of the first pandemic. It is still climbing during the epidemic, and this number has doubled to 6,000 tons per day. Tiku has been elected to a special committee set up by Prime Minister Modi for the past nine months. As conditions deteriorate and oxygen demand surges, Gasworld understands that the Indian government has tendered 50,000 tons of medical supplies. Liquid oxygen is open to the international community and India. An even more unusual step was the use of specially modified military transport aircraft that could transport liquid oxygen trailers within and into India, and it quickly became the subject of global media reports.
In the weeks and months that followed, this scenario prompted many people to ask questions from the simplest level, if industrial-grade oxygen is reasonable for more than 1 billion people in India, do we see that it is now used for medical purposes? The barrier of industrial oxygen has been broken?
A factor in the medical oxygen debate?
There is no doubt that there are many other factors to consider in this discussion, such as the many split operations of oxygen production, storage, transportation, monitoring and analysis. One of them comes from a leftist issue about the spread of "black fungus" in India.
The domestic publication India Express reported on May 27, 2021, how black fungus became “a post-Covid complication that shocked the medical community” due to the way this rare disease soared during the deadly second wave of pandemics 109 in the country. The report acknowledges that the use of steroids, uncontrolled sugar levels and low immunity are the main factors leading to the outbreak, but questioned whether the quality of oxygen supply in hospitals and the hygienic level of industrial oxygen cylinders rather than medical oxygen cylinders have any impact. .
It questioned whether there is a possible correlation between oxygen quality and black fungus?
Black fungus, or technically known mucormycosis, is a serious fungal infection that usually occurs in people with reduced ability to fight infection. The symptoms depend on where in the body the infection occurs. It most commonly infects the nose, sinuses, eyes, and brain, causing a runny nose, swelling and pain on one side of the face, headache, fever, blurred vision, swelling and swelling of the eyes, and tissue death. Other forms of disease may infect the lungs, stomach and intestines, and skin 110.
According to the same definition in Wikipedia, black fungus is transmitted by spores of Mucorales molds, most commonly through inhalation, contaminated food, or contamination from open wounds. These fungi are commonly found in soil, decomposing organic matter (such as rotten fruits and vegetables), and animal manure, but they usually do not affect people.
The online fact sheet of the US CDC (Centers for Disease Control and Prevention) affirmed the severity and impact of black fungus. It explained: "Mormycosis (formerly known as Zygomycosis) is a serious but rare fungal infection caused by a group of molds called Mucormycetes. These molds are found throughout the environment. Mucormycosis is mainly Affects people with health problems or taking drugs that reduce the body’s ability to resist germs and diseases. After inhaling fungal spores from the air, it most often affects the sinuses or lungs. It can also occur in cuts, burns, or other types of skin injuries After the skin." 111
An article in the Indian Express describes how to start reporting black fungus cases in most patients who are in a post-Covid state and use oxygen and steroids at the same time. An earlier BBC news article on May 9, 2021 described "black fungus crippling Covid patients in India" and how doctors reported recovering and recovering Covid when the second wave of Covid-19 was raging in India. There are a large number of cases-19 patients112. Similarly, an article published by The Economist on May 24, 2021 explained that nearly 9,000 people in India have been diagnosed with mucormycosis, and many of them have also been infected with Covid-19113.
As of July 21, 2021, another BBC News article reported that more than 4,300 people have died of black fungus in India, which is a “growing epidemic that mainly affects Covid-19 patients”. It went on to explain that at the time of writing, India had reported 45,374 cases of infection, citing Health Minister Mansouk Mandavia as saying.
As we all know, a large amount of industrial oxygen in India is diverted for medical purposes, and industrial gas cylinders are also used to fill the gaps in medical oxygen cylinders. In its May 2021 article, India Express pointed out that in Punjab and other states, some industrial gas cylinders have been upgraded to medical grade, but this is not feasible for all non-medical gas cylinders used by patients.
It went on to explain that it was relevant because "industrial oxygen is 99.67% purer than medical oxygen, but the condition of industrial oxygen cylinders is not as good as medical oxygen cylinders." The former is treated roughly without proper hygiene. In addition, they are prone to several micro leaks.
The article went on to quote a local gas company in Punjab and a senior medical official who seemed certain not only that industrial gas cylinders could not be used for medical purposes without major upgrades, but the agreement was often ignored due to time and reasons. Faced with such a huge demand, resources are limited.
Eventually, the fear of pollution was emphasized, and the question was asked whether a link could be established between the quality of oxygen supplied through industrial cylinders and the surge in black fungus cases. It should be noted here that the widespread reports of this growing epidemic of black fungus attribute the cause to the massive deployment of steroids in the fight against Covid-19. As mentioned earlier, on the one hand, it is helpful for treatment, But it will reduce the immune system on the other hand.
104. https://www.gasworld.com/hot-topic-understanding-medical-oxygen/2018708.article 105. https://www.gasworld.com/india-industrial-oxygen-to-be-used-as -medical-gas/2018836.article 106. https://www.gasworld.com/oxygen-new-oxygen-98-monograph-to-be-thinked/2018956.article 107. https://www.gasworld.com /india-restrictions-on-oxygen-supply-as-fight-against-covid-continues/2020774.article 108. https://www.gasworld.com/india-reaches-out-to-the-global-gas- community-for-help/2020798.article 109. https://indianexpress.com/article/explained/could-black-fungus-be-linked-to-industrial-oxygen-7326997/ 110. https://en.wikipedia .org/wiki/ Mucormycosis 111. https://www.cdc.gov/fungal/diseases/mucormycosis/index.html 112. https://www.bbc.co.uk/news/world-asia-india -57027829 113. https://www.economist.com/the-economist-explains/2021/05/24/what-is-black-fungus-the-infection-linked-to-covid-19-in-india? gclid = CjwKCAjwmK6IBhBqEiwAocMc8ixdxgU0TORX7TXDnVihh3qvJDBDoMsGuzfx-zoOA-9PrKynbzYB0BoC_rYQAvD_BwE&gcl src=aw. ds 114. https://www.bbc.co.uk/news/world-asia-india-57897682
105. https://www.gasworld.com/india-industrial-oxygen-to-be-used-as-medical-gas/2018836.article
106. https://www.gasworld.com/oxygen-new-oxygen-98-monograph-to-be-thinked/2018956.article
107. https://www.gasworld.com/india-restrictions-on-oxygen-supply-as-fight-against-covid-continues/2020774.article
108. https://www.gasworld.com/india-reaches-out-to-the-global-gas-community-for-help/2020798.article
109. https://indianexpress.com/article/explained/could-black-fungus-be-linked-to-industrial-oxygen-7326997/
110. https://en.wikipedia.org/wiki/Mucormycosis
111. https://www.cdc.gov/fungal/diseases/mucormycosis/index.html
112. https://www.bbc.co.uk/news/world-asia-india-57027829
113. https://www.economist.com/the-economist-explains/2021/05/24/what-is-black-fungus-the-infection-linked-to-covid-19-in-india?gclid= CjwKCAjwmK6IBhBqEiwAocMc8ixdxgU0TORX7TXDnVihh3qvJDBDoMsGuzfx-zoOA-9PrKynbzYB0BoC_rYQAvD_BwE&gclsrc=aw.ds
114. https://www.bbc.co.uk/news/world-asia-india-57897682
Can we say that our oxygen needs have been met? How are we prepared to deal with Covid-19, and how will we prepare in the future? Is it time to make a global estimate of the number of deaths caused by a lack of medical oxygen? all these are...
In the final analysis part of this exclusive series, we will ask how we are preparing for the next pandemic. If needed, is our oxygen supply chain ready? Have we learned the lessons of the Covid-19 pandemic? Can we even expect to improve our response?
We cannot lose the momentum of medical oxygen. For many low- and middle-income countries (LMIC), the difficulty of obtaining oxygen is systemic and long-term. This is what Robert Matiru, director of Unitaid's project department, said in an interview with gasworld.
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