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45 Cards in this Set
- Front
- Back
Ante (ante room) |
space outside the sterile compounding area where the sink and garbing items are located. Garbing and hand washing must be done in the ante room |
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Buffer area |
"Cleanroom". This is where the sterile compounding takes place |
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Biologically safety cabinet |
the "hood" and is located in the clean room |
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CSP |
Compounded sterile preparations (the IV drugs made in the cleanroom) |
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positive pressure |
keeps contaminated air from entering the hood to protect the CSP from contamination |
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negative pressure |
For hazardous drugs and keeps contaminated air away from the compounding staff and from exiting the hood. The air is vented to the outside. |
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ISO classification |
Refers to the number of particles that are permitted per volume of air. The smaller the number the cleaner the air |
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ISO 5 is used for.. |
All primary engineering controls (PECs) |
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ISO 7 is used for.. |
1) the buffer area 2) the ante area if it opens into a negative pressure cleanroom |
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ISO 8 is used for |
the ante area if it opens only into a positive pressure ISO 7 cleanroom |
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CSP low risk - BUDs and location |
BUD room temp - 48 hours BUD refrig - 14 days BUD frozen - 45 days Location: ISO 5, ISO 7 buffer area, ISO 8 ante area |
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CSP low risk with < 12-hr BUD |
BUD room temp and refrig - 12 hours BUD frozen - N/A Location: ISO 5 segregated from other operations |
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CSP medium risk BUD and location |
BUD room temp - 30 hours BUD refrig - 9 days BUD frozen - 45 days Location: ISO 5, ISO 7 buffer area, ISO 8 ante area |
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CSP high risk BUD and location |
BUD room temp - 24 hours BUD refrig - 3 days BUD frozen - 45 days Location: ISO 5 PEC, ISO 7 buffer area, ISO 8 or better ante area |
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CSP immediate use BUD and location |
BUD room temp - 1 hour BUR refrig and freezer - N/A Location: "Clean, uncluttered, functionally separate area" per USP |
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Osmolarity of human blood |
285 mOsm/L |
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Types of sterility testing for high risk CSPs |
1) tryptic soy broth (TSB) 2) fluid thipglycollate medium (FTM) AND should include bacterial endotoxin (pyrogen) testing prior to use |
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Type of sterilization for high risk CSPs |
terminal sterilization with pressurized steam sterilization using autoclave |
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Type of sterilization for high risk CSPs that are heat-labile (hormones, proteins) |
filtration with a 0.22 micron filter *test filter integrity with the bubble-point test |
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Type of sterilization used for products that can be damaged by moisture |
dry heat sterilization |
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Vertical flow hood (aka biological safety cabinets or chemotherapy hoods) flow.. |
air is blown from the top down to maintain sterility and provide protection for staff |
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Cleaning laminar flow hoods |
daily all surfaces are cleaned with 70% isopropyl alcohol in a side-to-side motion starting from the back of the hood |
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How many in. from the front edge of the hood should be clear? |
6 inches |
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In what kind of hood should chemotherapy be prepared? |
vertical hood |
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What disinfectant should be used fore cleaning and disinfecting the sterile compounding areas? |
germicidal detergent |
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What type of water should be used for cleaning sterile compounding areas? |
sterile water followed by 70% IPA |
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the order of cleaning in the sterile compounding areas |
from cleanest to dirtiest. buffer area-->ante area-->general supply area |
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Buffer area cleaning schedule |
At the beginning of each shift Before and after each batch After spills Every 30 minutes of continuous use Anytime contamination is suspected |
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Counters, work surfaces and floors cleaning schedule |
daily |
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Walls, ceilings and storage shelves cleaning schedule |
monthly |
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When is regard required? |
When the garb is exposed to less than ISO 8 conditions (garb is not supposed to be worn outside ante room) |
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When and which garb can be reused? |
The gown can be reused for the same shift if the person did not leave the ante room Task-specific eye wear and dedicated shoes may be reused and kept in the ante room and routinely cleaned with germicidal disinfectant |
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By whom can recalls be initiated? |
FDA request FDA order under statutory authority Company's initiative |
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Class I Recall |
Reasonable probability that the use or exposure will cause serious adverse health consequences or death. Ex: morphine tablet manufactured with 10x of active ingredient |
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Class II Recall |
Use or exposure can cause temporary or reversible adverse events or the probability of harm is remote. Ex: ketorolac inj have been recalled in 2010 and 2015 due to possibility of particles in the vials |
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Class III Recall |
Use or exposure is not likely to cause adverse health consequences Ex: the coloring on tablets may have been applied inconsistently |
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Each facility that does sterile compounding must have a quality assurance plan that should minimally include: (3) |
1. Personnel training and assessment 2. Environmental monitoring 3. Equipment calibration and maintenance |
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Endotoxins are produced by.. |
both GP and GN bacteria and fungi |
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The reagent for the bacterial endotoxins test (BET) is called... |
Limulus Amebocyte Lysate (LAL) which is based on clotting properties of the horseshoe crab's blood |
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temperature monitoring (sterile compounding) frequency |
daily (at a minimum) |
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frequency of qualified certifier must certify the area (sterile compounding) |
every 6 months (semi-annually) |
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frequency of air sampling by compounding personnel or cerifier (Sterile compounding) |
at least every 6 months |
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frequency of gloved fingertip sampling passing requires 3 samples (2 plates each) with zero CFUs |
verify at initial training low and medium risk (annually) high risk (semi-annually) |
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frequency of surface sampling (sterile compounding) |
periodically |
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frequency of HEPA filter pressure (sterile compounding) |
each shift (preferably) or daily (minimally) |