WebIf the compounding process takes more than 30 minutes, compounding must not be disrupted, and the work surface of the PEC must be disinfected immediately after compounding.” Contec Healthcare Comments: The key change is that the requirement only applies to the horizonal work surface (deck), not the entire PEC. WebApr 25, 2024 · If a C-PEC then perform appropriate decontamination, cleaning and disinfection, again cleaning with a sporicidal agent. Perform daily cleaning activities (easily cleanable horizontal surfaces and high touch surfaces then floors). Resume compounding. Perform dynamic air and surface sampling near the conclusion of the compounding day.
Compounding and the FDA: Questions and Answers FDA
WebApr 4, 2011 · The C-PEC for sterile compounding should be located in a C-SEC, which may either be an ISO Class 7 buffer room and ante-room (preferred) or an unclassified containment segregated compounding area (C-SCA). If the C-PEC is placed in a C-SCA, the beyond use date (BUD) of all compounded sterile preparations (CSPs) so prepared should … WebContainment primary engineering control (C-PEC)—the device in which compounds are mixed, including a containment ventilated enclosure (CVE) commonly called powder … excel spreadsheet in powerpoint
Handling hazardous drugs in health care Health Facilities …
WebNov 2, 2016 · Sterile compounding involves the preparation of drugs that will be injected into the patient or inserted into their eyes. Sterile compounding is done under stricter … WebAll containment primary engineering controls (C-PECs) used for manipulation of sterile hazardous drugs must be externally vented. Sterile HD compounding must be performed in a C-PEC that provides an ISO Class 5 or better air quality, such as a Class II or III biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). WebNov 2, 2016 · The USP 800 requirements for the C-PEC are that the equipment must create an ISO 5 environment (or better) within the equipment, be a ventilated device and operate continuously “if it supplies some or all of the negative pressure in the C-SEC or if it is used for sterile compounding.” excel spreadsheet how to freeze window panes