![]() Hazardous drugs, such as chemotherapy agents, antiviral medications, and immunosuppressive drugs pose significant health risks to medical personnel who handle them. In this article, we will explore the key features and regulatory requirements of CSTDs, and why they are essential in protecting healthcare workers from hazardous drug exposure. The use of CSTDs has been mandated in several countries, including the United States, due to the high incidence of hazardous drug exposure among healthcare workers. These devices serve as a critical tool to prevent exposure to hazardous drugs, which can cause serious health effects in healthcare workers. These filtration requirements, combined with other stringent controls on air quality, airflow patterns, and pressure differentials, help to create a safer compounding environment compliant with USP guidelines.According to the National Institute for Occupational Safety and Health (NIOSH), a CSTD is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapors outside of the system1. This exhaust air should ideally be expelled outside the building, but if it is to be re-circulated, it must pass through a redundant HEPA filtration system before returning to the general circulation, as a precautionary measure to prevent potential contamination. ![]() These filters are thus effective in limiting the spread of HDs, ensuring cleaner and safer air within the cleanroom and the surrounding areas.įurthermore, any area that is externally vented, such as rooms used for HD storage or the Containment Secondary Engineering Controls (C-SECs), must employ proper exhaust ventilation. HEPA filters are critical components in maintaining air quality as they can capture at least 99.97% of airborne particles of 0.3 micrometers (µm) in diameter. The objective is to capture and contain hazardous particles to minimize the risk of environmental contamination and personnel exposure. ![]() USP Chapter stipulates that the Containment Primary Engineering Controls (C-PECs), the devices used for compounding hazardous drugs (HDs), must be externally vented through High-Efficiency Particulate Air (HEPA) filtration. This storage should occur in an externally ventilated room under negative pressure, necessitating a minimum of 12 air changes per hour (ACPH). ![]() The continuous management of contamination risk pivots on rigorous environmental monitoring of air, personnel, and surfaces.Īntineoplastic hazardous drugs (HDs), which necessitate manipulation beyond repackaging of final dosage forms, along with any HD active pharmaceutical ingredient (API), must be segregated from non-HDs to preclude contamination and personnel exposure. Hazardous compounding operations are carried out in the HD Buffer Cleanroom. The anteroom in the facility functions as an intermediary space, where staff don their personal protective equipment (PPE). ▪ Temperature at approximately 20 degrees Celsius (68 degrees Fahrenheit) Critical parameters are monitored in the space each day manually or automatically including: It incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area. Secondary engineering control spaces are the areas where the PEC is placed (e.g., a cleanroom suite). Types of Containment Primary Engineering Control Devices (C-PEC)Ĭlass II Biological Safety Cabinet (BSC) externally ducted and HEPA filtered exhaustedĬompounding Aseptic Containment Isolator (CACI)ĬSP and Hazardous CSP Secondary Engineering Controls The ISO 7 CSP hazardous drug compounding area will house an ISO 5 primary engineering control device for compounding operations. Hazardous CSPs and Containment Primary Engineering Controls Vertical or Horizontal Laminar Airflow Hoods (LAFS) Types of Primary Engineering Control (PEC) Devices The ISO 7 CSP sterile drug compounding area or buffer area will house an ISO 5 primary engineering control device for compounding operations.
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