Turbulent airflow in the direct compounding area drastically removes the ability to compound in ISO 5 first air and puts patients at risk. While there are many types of pharmacy isolators with HEPA filtered ISO 5 airflow, the airflow in some of these devices may be turbulent flow - not laminar/unidirectional. Unidirectional airflow as defined by CETA CAG-002 is described as, “…an airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.” Air that is not unidirectional is called turbulent airflow. USP requires that isolators provide unidirectional airflow in all pharmacy isolators. Class II BSCs are a logical improvement over CACIs because of their open sash and unrestricted working area.ĭoes My Isolator Have Unidirectional Airflow? While the USP placement requirement for CACIs also extends to Class II BSCs, CACIs require the same HD garbing, making them ergonomically unfavorable when working through the gauntlets and gloves that allow access to the direct compounding area. ![]() Pharmacies compounding in this manner must classify these products as Category 1 CSPs.ĬSPs that are made in isolators within a cleanroom suite with an ISO 7 buffer room and ISO 8 anteroom are granted a full BUD and Category 2 or 3 classification. CAIs and CACIs not placed inside a cleanroom suite with an ISO 7 buffer room and ISO 8 anteroom will only be granted a 12-hour BUD (24-hour BUD if refrigerated). These gloves enable pharmacy technicians to perform their compounding tasks while maintaining the necessary barrier between the operator and the sterile environment within the isolator.Īlthough CAIs and CACIs will still be accepted as primary engineering controls (PECs) for sterile compounding in the new USP update, a new change involves a shortening of the BUD for CAIs and CACIs placed outside of cleanrooms. To access the primary working area, CAIs and CACIs are equipped with gloves located at the front of the isolator. Materials are transferred in and out of these devices through an ISO 5 HEPA filtered transfer chamber. CACIs are negative pressure devices for compounding of sterile hazardous drugs, including chemotherapy preparations, while minimizing the risk to personnel.Ī CAI pharmacy isolator in an unclassified area of an inpatient pharmacy.īoth CAIs and CACIs offer a direct compounding area with HEPA filtered ISO 5 unidirectional (laminar) airflow. ![]() ![]() CAIs are positive pressure devices for compounding sterile non-hazardous CSPs. RABS come in two formats: Compounding Aseptic Isolators (CAIs) and Compounding Aseptic Containment Isolators (CACIs). Pharmacy isolators, also referred to as restricted-access barrier systems, or RABS for short per the new USP, are enclosed PECs designed for compounding sterile products (CSPs). By proactively understanding these changes, you can ensure your pharmacy’s compliance and continue to provide safe and efficient compounding services. With major changes on the horizon, now is the time for your pharmacy to examine these new regulations and other challenges associated with pharmacy isolators. However, effective November 1, 2023, these isolators will lose practical benefits in areas of Beyond Use Dating (BUD) while gaining more stringent room placement requirements, placing them on par with other primary engineering controls (PECs) such as laminar airflow workstations (LAFWs) and Class II Biosafety Cabinets (BSCs). Traps and Other Vacuum Pump Accessoriesįor years, hospital pharmacies have relied on pharmacy isolators, including cumbersome and complex glove boxes, to compound sterile products.Miscellaneous Freeze Dry Parts & Accessories.Kjeldahl, Fat & Crude Fiber Apparatus Accessories.Dry Evaporators, Concentrators & Cold Traps.Class II, Type B2 (Total Exhaust) Biosafety Cabinets. ![]() Biosafety Cabinet & Clean Bench Accessories.Balance, Bulk Powder & Equipment Enclosures.Biological Safety Cabinets & Enclosures.
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