A compressed gas risk assessment is an important component of your Contamination Control Strategy (CCS) and should start with determining the involvement and final use of the process gases in pharmaceutical industries.
Guidelines for Control of Compressed Gas Systems
Because compressed air is used in many manufacturing processes in close proximity or contact with the products, control of the cleanliness of the utility is paramount. The purity class of the compressed air must be determined. To do this, the contaminants of the system must be understood through a Compressed Gas Risk Assessment and CCS.
A compressed air system is generally maintained in a dry state with a low dew point that drastically reduces the risk of microbial growth. However, the compressed air quality can be equally threatened by solid particles, water, and total oil, which represent the main contaminants in a compressed air system. For each contaminant, it is necessary to determine that the concentration is within a certain range, established in regulations
The FDA regulation requires that the compressed gas has a purity, as well as microbiological and particle content after filtration, that is equal to or better than that of the environment in which it is used, and EU GMP Annex 1 regulation requires that gases be of appropriate quality with all relevant parameters and contaminants specified. The quality of the installation, and thus of the compressed air, must be confirmed during the qualification phase, so that the limits for particle and microbial concentration, moisture, liquid water, and total oil are in line with expectations.
During the early stages of installation and verification of plant quality, sampling points for quality control or process purposes must be determined. Their locations must be identified through a risk analysis so that no potential contaminants are excluded (including cleaning agents). Generally, sampling points for compressed air, as well as for other gases, must be easily accessible, away from sampling points of other utility systems to avoid cross contamination, and clearly and uniquely identified. The sampling point should therefore reflect the quality of the compressed air at the point of use. If the air pipeline is equipped with a sterile filter, the sampling point should be placed before it.
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This paper discusses:
- how compressed air systems function
- guidelines for control of compressed gas systems
Including- FDA Regulations
- EU GMP Annex 1
- ISO 8573 for Compressed Air
- the importance of routine monitoring and preventive maintenance
- how PMS can help you with monitoring compressed gases
