USP 800 Updated 2024/2025 Actual Questions and answers with complete solutions
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Course
USP 800
Institution
USP 800
Areas that should have environmental wipe sampling - 1.) inside the C-PEC, 2.) work areas near
the C-PEC 3.) areas adjacent to the C-PEC 4.) patient administration areas
A hand sink must be placed in the ISO 7 buffer room for C-PECs within ______ of the door - 1
meter
A line demarcation must be...
USP 800
Areas that should have environmental wipe sampling - 1.) inside the C-PEC, 2.) work areas near
the C-PEC 3.) areas adjacent to the C-PEC 4.) patient administration areas
A hand sink must be placed in the ISO 7 buffer room for C-PECs within ______ of the door - 1
meter
A line demarcation must be defined in the negative pressure area for the purpose of - garbing
Acceptable C-PECs for non-sterile compounding of HDs - 1.) Class 1 or 2 BSCs 2.) containment
ventilated enclosure (CVE), 3.) CACI
Acceptable C-PECS for sterile compounding of HDs - 1.) Class 2 or 3 BSC or 2.) CACI
Access to areas where HDs are handled must be - restricted to authorized personnel
ALL personal protective equipment should be disposed of after HD compounding prior to - leaving
the C-SEC
All personnel who are potentially exposed to HDs must periodically go through - medical
surveillance and should have baseline and periodic data on biological markers
Antineoplastics on the HD list must remain in ________ so long as they are being manipulated prior to
dispensing - containment
A C-PEC must operate ___________ if it supplies the negative pressure or if it is used for __________
compounding - continuously, sterile
, Areas where HDs are handled must be located - away from breakrooms, patient/visitor areas
Before the entrance to HD handling areas must be - signs prominently displayed denoting the area
as hazardous
Chemotherapy gloves must be _______ free - powder - contamination risk
Chemotherapy gloves must be changed - every 30 minutes or anytime a defect is detected
Cleaning steps + definitions - 1.) deactivating = render a compound inert 2.) decontamination =
remove the residue 3.) cleaning = remove organic/inorganic material 4.) disinfect = remove
microorganisms
Compounding equipment such as mortars, pestles etc for HD compounding should be - dedicated
to HD compounding and NOT used for other compounds
Containment segregation compounding areas (C-SCA)are - separate negative pressure areas with
at least 12 air exchanges per hour
Definition of containment primary engineering control under USP 800 - C-PEC = a ventilated
device meant to minimize worker and environmental exposure to HDs when directly handling HDs
Definition of containment secondary engineering control under USP 800 - C-SEC = is the room in
which the C-PEC is placed
Definition of supplemental engineering controls under USP 800 - are adjunct controls to offer
additional levels of protection - such as drug transfer devices
During cleaning of HD areas PPE must be worn including ____ pairs of chemotherapy gloves - 2
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