Which class of air is necessary for a Laminar Airflow System (LAFS) to provide in sterile compounding?

A Laminar Airflow System (LAFS) is designed to provide a sterile environment for compounding aseptic preparations. To achieve this, it must maintain a specific level of air cleanliness, which is measured using the ISO classification system. The correct choice of ISO class 5 signifies that the air in the environment has a maximum allowable count of 3,520 particles per cubic meter that are 0.5 micrometers in size or larger.

This level of cleanliness is essential because it minimizes the risk of contamination from particles and microorganisms during the preparation of sterile products. An ISO class 5 environment ensures that the probability of microbial contamination is kept to a minimum, which is crucial for the safety and efficacy of sterile compounds.

In contrast, ISO classes 3, 4, and 6 offer different levels of air quality, with class 3 being overly stringent and unnecessary for sterile compounding, while class 4 and class 6 do not provide the same level of protection as class 5 for the specific needs of sterile compounding environments. Thus, ISO class 5 is the appropriate standard for a Laminar Airflow System to ensure safety and sterility during compounding processes.