Where are Category 1 CSPs typically prepared?

Category 1 Compounded Sterile Preparations (CSPs) are typically prepared in an unclassified Segregated Compounding Area (SCA). This type of environment is specifically designed to limit the potential for microbial contamination while facilitating the compounding of low-risk preparations. The SCA is required to maintain certain environmental controls but does not have the stringent classification requirements of a cleanroom.

An unclassified SCA allows for flexibility while still ensuring some level of environmental integrity. Category 1 CSPs are low-risk preparations that do not require the same level of sterility assurance as higher-risk preparations, which is why the SCA is sufficient for their compounding needs. The SCA is designed to offer some protection from contamination, making it suitable for preparing these types of sterile products.

In contrast, a classified cleanroom is not the environment typically designated for Category 1 CSPs, as it is reserved for higher-risk sterile compounding requiring stringent environmental controls. Laminar flow hoods, while essential, are specific pieces of equipment that can be located within a cleanroom or an SCA. Additionally, preparing CSPs in any designated sterile area does not accurately reflect the specific requirements and guidelines outlined for the preparation of Category 1 CSPs, which