The requirement for making low-risk sterile preparations is specifically tied to maintaining a controlled and clean environment to ensure the safety and efficacy of medications. An ISO 5 or better biological safety cabinet is designed to provide a sterile airflow environment that minimizes contamination risks while compounding sterile products. The ISO 5 classification means that the air cleanliness is strictly controlled, allowing for a maximum number of particles per cubic meter to be low enough to support sterile compounding.
Low-risk sterile preparations typically involve simple manipulations and compounding techniques, and the environment where these preparations are made must adhere to particular standards to ensure the absence of harmful microorganisms. The use of an ISO 5 cabinet ensures that the compounder is protected from airborne particles and contaminants while also protecting the product being compounded.
While an ISO 6 or better hood might seem sufficient, it does not provide the same level of protection required specifically for sterile compounding as an ISO 5 cabinet does. Additionally, a standard cleanroom setup may not ensure the focused environment needed for low-risk compounding, and standard laboratory equipment lacks the necessary sterilization assurance. Hence, the use of an ISO 5 or better biological safety cabinet is essential for safe and effective sterile preparation in line with the standards set forth in pharmacy practice