What does ISO 5 specify for the compounding process?

ISO 5 specifies the standard for sterile airflow that is crucial during the compounding process, particularly in environments where sterile preparations are made, such as in pharmacies or hospital settings. This standard ensures that the area where compounding occurs is maintained in a controlled environment to minimize the risk of contamination from particles, microorganisms, or other contaminants that could compromise sterile products.

In a setting following ISO 5 guidelines, the airflow is designed to filter and clean the air, typically through high-efficiency particulate air (HEPA) filters, to provide a sterile environment necessary for preparing injectable medications, sterile powders, and other formulations. Achieving the right level of airflow is vital for ensuring safety and efficacy in pharmaceuticals that are administered to patients.

The other options do not directly relate to ISO 5 standards. For instance, time requirements, temperature control, and drug potency verification are essential aspects of pharmacy practice but are governed by different standards and protocols outside the specific focus of ISO 5 airflow standards.