Headspace Analysis

Headspace analysis can be used for a variety of purposes in the pharmaceutical/biomedical industries including organic volatile impurities in drug substances, determining off-gassing products from medical devices, or how thoroughly a product container is filled with nitrogen. Organic volatile impurities is discussed in another article so this article will expand on the latter two topics.

Medical Device Testing

Several types of plastics are used in the construction of medical devices. Since plastics are organic polymers, the presence of residual monomer, as well as other materials used in their manufacture, can be of concern in the final product. This is especially true if the device is used in any sort of respiratory therapy, such as a nasal cannula. We analyzed one of these products manufactured using polyvinyl chloride (PVC) tubing and a certain cement to connect the parts. When the off-gassing products were analyzed using GCMS, large concentrations of cyclohexanone and methyl ethyl ketone were detected. Similarly, acrylic products can contain residual monomers such as methyl methacrylate. These types of contaminants can cause irritation if inhaled, even in small concentrations. They can also off-gas or leach from containers into drug products.

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Inert Fill Gases

A different problem is encountered in air-sensitive materials. These are generally packaged under a blanket of inert gas, usually nitrogen or argon. The quality of this fill has a serious impact on the stability of the product. This makes control of the fill gas a major consideration in production of these drugs. The gases present in the headspace above a sample can easily be analyzed using Gas Chromatography with a Thermal Conductivity Detector (GC/TCD). This analysis detects nitrogen, oxygen, carbon monoxide and carbon dioxide which allows manufacturers to monitor the quality of their finished product. We will typically receive samples from the beginning, middle and end of a production run, which are then monitored for headspace composition. By measuring the nitrogen and oxygen in the headspace, the quality of the product is assured, as well as the consistency of the flushing process.

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