New methods address helium shortage challenges
Due to several factors, there currently is a world-wide shortage of helium supply. This shortage will impact pricing and availability of helium supplies throughout the rest of 2012 and potentially into the future. While this shortage will impact many industries, one impact on the pharmaceutical industry will be for product testing methods that utilize gas chromatography. These methods include assay, related substances, residual solvents and extractables and leachables to name a few. Helium is typically utilized as both carrier gas, inlet purge gas and detector make-up gas for gas chromatography methods.
Eurofins Lancaster Laboratories has extensive experience in the development and validation of gas chromatographic methods for the pharmaceutical industry and can offer alternatives to the use of helium gas. This includes developing new methods, as well as modifying existing methods to utilize hydrogen or nitrogen in place of helium. Following modifi cation of existing methods, Eurofins Lancaster Laboratories can either perform necessary validation on the method or an appropriate bridging study to the original method.
While the entire industry is feeling the effect of the helium shortage at this time, Eurofins Lancaster Laboratories feels that long-term gains can be achieved by converting existing methods to hydrogen or nitrogen. The world wide supply of helium is limited to a fixed natural reserve, and pricing for this gas has continued to increase, whereas, the supplies of hydrogen and nitrogen are renewable and cost effective.