What type of compounding is the cleanroom suite designed for?

The cleanroom suite is specifically designed for compounding sterile preparations, which fall under Category 1 and Category 2 Compounded Sterile Preparations (CSPs). These categories are defined by the risk levels associated with the compounding process.

Category 1 CSPs are considered low-risk and involve simple procedures that adhere to stringent sterile techniques, typically performed in a controlled environment, such as a cleanroom. Category 2 CSPs, on the other hand, involve a higher level of complexity and risk, often requiring more advanced aseptic techniques and may necessitate additional precautions to maintain sterility. The cleanroom is essential for these types of compounding because it provides a controlled environment that minimizes contamination risks, ensuring the safety and efficacy of the sterile products being prepared.

In contrast, Category 3 and Category 4 CSPs generally refer to higher risk levels or more complex compounding situations, which may not strictly require a controlled cleanroom environment. Non-sterile compounding does not necessitate the same level of environmental control as sterile compounding, which further differentiates the requirements and purpose of the cleanroom suite. Therefore, the suite is specifically tailored to meet the stringent needs of Category 1 and Category 2 CSPs, focusing on