Why do I need to sample compressed gasses for the presence of micro-organisms?
Compressed air plays a vital role in various manufacturing processes, such as controlling valves and cylinders, cutting materials, mixing substances, and packaging goods. Within the humid environment of a compressed air system, micro-organisms like bacteria, yeasts, and molds find ideal conditions for growth. These micro-organisms can pose significant risks to manufacturers, potentially leading to product contamination, recalls, a loss of public trust, and in severe cases, facility closures and revenue losses. To ensure product quality and prevent contamination, manufacturers must establish a comprehensive compressed air monitoring program.
If a facility incorporates compressed air or gas in their manufacturing processes, it is essential to include microbial testing as part of their compressed air monitoring plan. Manufacturers typically employ Microbial Impaction Samplers to assess the cleanliness of their compressed air systems. The analysis of ensuing microbial growth aligns with ISO 8573-7 standards. This analysis provides critical data, including the total plate counts of colony forming units (CFU) and the classification of bacterial cell wall morphologies into two main categories: Gram-positive or Gram-negative.
What are the limits for the CFu count when sampling gasses?
The accepted microbial contamination is related to the Good Manufacturing Practice (GMP) interpretation.
FDA Aseptic Filling Guidance - “A compressed gas should be of appropriate purity and its microbiological quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced”.
ISPE Good Practice Guide – “Typically equal to the at rest condition of the area served”.
ISO 14644 / EU GMP Grade A Class 5 – “<1 CFU/m3”.
Therefore the acceptable level of micro-organisms is related to the cleanroom class.
Tests microbiological quality of compressed air/gas used in cleanrooms
Test quality of Air/Nitrogen/CO2
Compressed gas test and check of the precision level
Tests microbiological quality of compressed air/gas used in cleanrooms microbiological quality of compressed air/gas used in cleanrooms
