NSF International provides minimum standards for cabinet classifications and certification.Ĭonsidering these aspects, healthcare institutions can make informed decisions about the best primary engineering control for their needs, ensuring safety while following USP and standards. BSCs offer three types of protection: operator, product, and environmental. USP advises using specific types of BSCs for hazardous drug sterile compounding, including Class II, Type A2 Class II, Type B2 and Class III. Some systems might require a purge time to align with manufacturer’s specifications before use. Frequently turning the devices on and off might affect the device’s lifespan and change the pressure gradients within the secondary engineering control. BSC designs are verified by NSF International/American National Standard and undergo field testing, while CACI design specifications don’t require verification, with manufacturers providing testing standards for field-testing.Īll primary engineering controls are designed to run continuously. The design and testing standards are also important. The material of the primary engineering control should be durable enough to withstand frequent cleanings with strong chemicals, such as stainless steel or high-grade plastics, while preserving its protective integrity. The convenience of preparing multiple doses at once.Ergonomics for both low-volume and high-volume compounding.The procedure for product entry and preparation exit.The costs of acquisition, maintenance, power, and specialized supplies.When choosing a primary engineering control (PEC), several factors should be considered: These include requirements for personal protective equipment, facility design, air quality, negative pressure, using a closed system drug-transfer device, cleaning procedures, and USP beyond-use dating (BUD). While USP doesn’t specify whether to use a biological safety cabinet (BSC) or a compounding aseptic containment isolator (CACI) for compounding hazardous drugs (HDs), both pieces of equipment have similar usage conditions. This regulation obligates employers to develop a method for identifying and communicating about any hazardous chemicals that employees could encounter during their work. Adhering to the hazard communication standard developed by the Occupational Safety and Health Administration (OSHA) is crucial in these cases. However, healthcare facilities might also handle other dangerous substances. It’s important to note that NIOSH’s focus is on FDA-approved hazardous drugs. NIOSH also sorts hazardous drugs into three groups: antineoplastic drugs, non-neoplastic hazardous drugs, and drugs with reproductive effects. The NIOSH definition relies on six characteristics: cancer-causing potential, teratogenicity or developmental toxicity, reproductive toxicity, low-dose organ toxicity, genotoxicity, and molecular similarity to another hazardous drug. The National Institute for Occupational Safety and Health (NIOSH) further elaborates on what is classified as a “hazardous” drug. Conversely, USP delivers advice for the safe manipulation of hazardous drugs and focuses on the protection of healthcare workers, the facility environment, and patients who are exposed to these potential high-risk medications. USP predominantly issues directives to ensure precision and contamination-free procedures during the compounding of sterile products. The implementation of the United States Pharmacopeia (USP) and USP guidelines has transformed the approach to sterile compounding of potentially hazardous chemotherapies and biotherapies in hospital environments and compounding pharmacies. Understanding the USP and USP Standards: Policies, Procedures and Equipment in Sterile Compounding
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