Original article published on PharmaManufacturing.com
Pharmaceutical manufacturers can apply cleanroom standards to compressed air systems to ensure the quality and safety of their end-products. Often overlooked due to lack of specific regulations, compressed air systems are critical to many processes in a cleanroom environment. Cleanroom specifications can be applied to compressed air systems and included in monitoring plans for year-round quality assurance.
The International Society for Pharmaceutical Engineers (ISPE) Good Practice Guide, recommends, “in cases where the gas is entering a classified area, it is required to at least meet the room classification limits established for the cleanroom environment” (2016). Additionally, the most recent US FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice recommends that “compressed gas should be of appropriate purity… and it’s microbiological and particle quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced.”
Using the US FDA and ISPE GPG recommendations, pharmaceutical manufacturers can properly evaluate the quality of their processed gases including nitrogen, oxygen, argon, carbon dioxide, and compressed air. Chad Larrabee, Global Product Management Leader of Ingersoll Rand and GPG: Process Gases co-chair, explains that the compressed air used in cleanroom environments should match the quality levels required by that room (2019) as mentioned by the FDA.
The International Organization for Standardization (ISO) standard, ISO 8573:2010 is commonly used for compressed air applications across a variety of industries. Pharmaceutical manufacturers often favor cleanroom specifications over ISO 8573-1 to adhere to their cleanroom facility. To facilitate communication between manufacturers and distributors, ISO 8573-1 specifications can be translated into cleanroom specifications. The following chart demonstrates the comparison between both standards and how they can be used together to prevent confusion.