Transcription of Chapter 21-4.1.0 - Design Requirements for Compounded ...
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Oct 31, 2017 Chapter - Design Requirements FOR Compounded STERILE AND HAZARDOUS DRUG PREPARATION AREAS 1 A. Purpose .. 1 B. Scope .. 1 C. Background .. 1 D. Definitions .. 2 4 A. General Design Criteria for facilities .. 4 B. Design Criteria for facilities using BSCs and LAFWs .. 6 C. Design Criteria for facilities using CAIs and CACIs .. 6 D. Typical Room Layouts .. 7 Tables: Construction Guidelines for Pharmacy compounding 8 Table 1: Requirements Common to All Locations and Compounded Pharmaceuticals .. 8 Table 2A: Standard Requirements for Low and Medium Risk CSPs .. 9 Table 2B: Reduced Requirements for Low and Medium Risk CSPs in Compliant Isolators .. 10 Table 3: Requirements for Low Risk CSPs w/ BUD <12 hours .. 11 Table 4: Requirements for High Risk CSPs .. 12 Table 5: Requirements for Non-sterile Hazardous Drug Manipulations .. 13 INTRODUCTION A. Purpose This Chapter provides guidance on minimum Requirements for the designing of IHS pharmacies to ensure safe and contamination free storage and processing of Compounded sterile preparations (CSP) and hazardous drugs (HD).
(h) Exhaust from hazardous drug compounding area should be clearly marked as to the hazard where the exhaust leaves the building. B. Design Criteria for facilities using BSCs and LAFWs The rooms used for compounding sterile and hazardous drug preparations shall comply with the design recommendations listed below in the Tables.
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