According to ISO standards, which class is required for a direct compounding area (DCA)?

A direct compounding area (DCA) must maintain a specific level of cleanliness and particulate control to ensure safe preparation of sterile products. According to ISO standards, a DCA is required to meet ISO Class 5 criteria. This classification indicates that the area must have a maximum allowable particle count of 3,520 particles per cubic meter for particles that are 0.5 micrometers in size and larger.

The importance of ISO Class 5 lies in its ability to minimize the risk of contamination during the compounding process, which is crucial for maintaining the sterility of drugs and preparing them safely for patients. In environments like pharmacies where sterile compounding is performed, adhering to this standard helps to safeguard patient health by ensuring that the environment is as free from contaminants as possible.

In contrast, other ISO classes such as Class 3, 7, and 8 do not provide the same level of particulate control necessary for sterile compounding. ISO Class 3 allows for too many particles, while Class 7 and Class 8 are intended for less critical environments where the risk of contamination is not as high, which is why they are not suitable for a DCA.