Helium shortage jeopardizes pharmaceutical production
Blockade of the Strait of Hormuz has consequences for drug production and drug supply
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The German pharmaceutical industry is warning of the consequences of an ongoing war with Iran for the supply of medicines: The impending shortage of helium and other petrochemical raw materials is putting pressure on central analysis and production processes that are required across the manufacture of tablets, infusions and modern biologics. Helium is a critical cross-sectional raw material - Germany is almost entirely dependent on imports, a large proportion of which pass through the Strait of Hormuz.
"The Iran war has not yet reached the shelves of pharmacies. However, the longer the blockade of the Strait of Hormuz lasts, the greater the concern in the laboratories and factories of German pharmaceutical manufacturers," says Dorothee Brakmann, Managing Director of Pharma Deutschland. "Manufacturers are particularly concerned about the availability of helium. If the gas becomes scarce and expensive, quality controls come to a standstill. Companies will then no longer be able to release medicines to the usual extent - even if active ingredients and packaging materials are available."
Helium is primarily used in the pharmaceutical industry for gas chromatography quality controls, which in many cases are stipulated in the pharmacopoeia. These analyses are a prerequisite for the batch-by-batch testing and marketing of medicinal products. "These methods cannot be switched to other gases or alternative methods overnight - this would require new method developments, validations and official approvals and would cost valuable time," says Brakmann.
According to the industry, the first effects of the situation in the Middle East are already visible along the supply chains: rising transportation and energy costs, a lack of or more expensive primary packaging materials such as glass bottles and closures, as well as higher prices for petrochemical raw materials and ethanol. A long-term disruption to the Strait of Hormuz would further destabilize the already strained supply situation.
"We must clearly state the risks," emphasizes Brakmann. "If we don't take countermeasures now, there is a risk of bottlenecks in the medium term, particularly for medicines whose quality control depends on helium."
Pharma Deutschland is therefore calling for helium to be classified as a strategically relevant commodity for the healthcare sector and for conversion processes in analytics to be made easier from a regulatory perspective. "We need to secure the currently missing (raw) materials for critical medical applications - just as other industries are demanding for their key raw materials," says Brakmann.
Note: This article has been translated using a computer system without human intervention. LUMITOS offers these automatic translations to present a wider range of current news. Since this article has been translated with automatic translation, it is possible that it contains errors in vocabulary, syntax or grammar. The original article in German can be found here.
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Topic world Gas chromatography
Gas chromatography is an essential method in analytical chemistry for the separation and analysis of volatile compounds. Due to its high resolution and sensitivity, it has become firmly established in areas such as environmental analysis, food chemistry or forensic science. GC provides precise and reliable results and enables deep insights into the chemical composition of samples.
Topic world Gas chromatography
Gas chromatography is an essential method in analytical chemistry for the separation and analysis of volatile compounds. Due to its high resolution and sensitivity, it has become firmly established in areas such as environmental analysis, food chemistry or forensic science. GC provides precise and reliable results and enables deep insights into the chemical composition of samples.