Ĭan the same hood be used to compound low-risk and medium-risk levels radiopharmaceuticals? Hence, 'turbulent airflow' isolator (either CAI or compounding aseptic containment isolator ) generally does not meet the requirements in USP. Most turbulent flow isolators especially when combined with a static pass-through (the so-called 'open' isolators) have the possibility that contamination might be brought into the isolator when the materials are transferred in and out through an interchange chamber. One of the key points when determining if an isolator is closed or open is whether or not particles are allowed to pass unfiltered from the room to the isolator during material transfer. "The airflow in the PEC shall be unidirectional (laminar flow)."Īlso, although turbulent air flow can be acceptable within 'closed' isolators, compounding aseptic isolators are generally considered 'open' isolators.air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding." Such area shall contain a device that provides unidirectional airflow of ISO Class 5. "Segregated Compounding Area-A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD."First Air-The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free."."Direct Compounding Area (DCA)-A critical area within the ISO Class 5…primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.".Both pairs must be chemotherapy gloves that meet American Society for Testing and Materials (ASTM) standard D6978.ĥ.2 – Techniques, procedures, or equipment for hazardous or non-hazardous sterile productsĥ.Would a facility be in compliance with USP if a "turbulent airflow" compounding aseptic isolator (CAI) is employed to compound or dispense sterile drug preparations (assuming that the placement of the above CAI and personnel cleansing meet the requirements as stated in USP )?Īlthough the USP contains the statement: "The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein," it appears that compounding aseptic isolators generally do not meet the following requirements stated in USP : ![]() Answer D is incorrect because when compounding sterile HD, a set of sterile gloves must be worn on top of another pair gloves. Furthermore, all hazardous drugs must be stored and prepared in a negative pressure ISO 7 clean room. When compounding hazardous drugs, a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) must be used, making answer C incorrect. The most recent release from NIOSH has been a 2020 draft following the 2016 published list. When compounding HD, you must follow USP Chapter 797 for sterile compounding and USP 795 for non-sterile compounding in addition to USP Chapter 800 which give standards for proper handling of HD making answer A and E correct.Īll pharmacies that handle hazardous drugs must compile an updated list every 12 months using the current NIOSH HD list. When compounding sterile hazardous drugs, the beyond-use date (BUD) is found in USP Chapter 797 A single pair of sterile gloves should be worn when compounding an antineoplastic for intravenous useĮ. When compounding doxorubicin, a vertical laminar airflow workbench (LAFW) should be usedĭ. ![]() The list of hazardous drugs is maintained by National Institute for occupational safety and health (NIOSH)Ĭ. USP Chapter 800 contains the standards for handling hazardous drugsī. Which of the following is/are true when it comes to compounding hazardous drugs (HD)? Select all that apply.Ī.
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