Contamination Control Strategies For Pharmaceutical Manufacturing Environments

By Frank Panofen

Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. These applications, such as aseptic packaging, purging, and filtration, are critical processes monitored for their efficacy. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.

Many GMP standards recommend sampling process gases for contamination before use in critical areas of manufacturing. This step, along with many others that make up a contamination control strategy, contribute to the purity and quality of the final product.