BOC assists in EP helium monograph validation
BOC, the world's largest supplier of helium, has validated the analytical methods proposed for the first monograph for helium in the European Pharmacopoeia (EP).
BOC, the world's largest supplier of helium, has validated the analytical methods proposed for the first monograph for helium in the European Pharmacopoeia (EP).
BOC completed a validation trial on a gas analyser capable of measuring trace methane in helium. Monitoring the level of trace methane in helium gives a good indication of the correct operation of the helium purification process, as methane will be the most prominent contaminant, BOC says.
Although it is not thought that low levels of methane in helium have a detrimental effect on patients, the EP monograph states an upper limit of 50 ppm.
BOC loaned an analyser from Servomex, allowing it to complete the validation trial and confirm the specification within a two-week deadline.
Servomex provided a 4100 gas purity analyser with a 0-50/500 ppm methane measurement range and an intrinsic error (accuracy) of better than one per cent of reading or 0.5 ppm(v) methane, whichever is greater.
During the validation trial, the Servomex 4100 gas analyser was tested against the ICH Q2 guidelines that cover, for example, linearity, accuracy, precision, and detection limit.
As a result of the validation trial carried out by BOC, the new EP will specify the monitoring of trace methane in helium using infrared gas analysis.
