Ch 5: Sterile Compounding Flashcards
ISO air quality
international standards organization (ISO) determined by #particles per volume of air of a specified particle size. lower the count, cleaner the air.
ISOs of common areas
primary engineering control aka PEC (hood or isolator): 5. buffer room/IV room (where PEC is located): 7. ante area: 8 if opens to (+)pressure buffer or 7 if opens to (-)pressure buffer.
HEPA filters
high-efficiency particulate air maintains clean air in compounding areas. 99.97% efficiency in removing particles as small as 0.3 microns. products should always be facing first air from HEPA during compounding (nothing behind if horizontal flow, nothing above if vertical flow)
air changes per hour (ACPH)
rate at which the air is vented to outside. 30 ACPH required for primary engineering control
biological safety cabinet (BSC)
aka chemo hood, neg pressure hood used to prepare hazardous CSP
isolators
glove boxes, type of primary engineering control completely enclosed. can be pos pressure for nonhazard drugs or neg pressure for hazard drugs.
laminar airflow workbench or laminar airflow hood
common primary engineering control for preparing non-hazardous CSPs. laminar airflow moves at same speed in same direction in parallel lines to avoid landing on surfaces and causing contamination.
line of demarcation
line separating 2 diff areas, usually separating the ante area and buffer area
neg pressure
new airflow is flowing in, to protect staff from toxic fumes, air is vented to outside. required for hazardous drugs
pos pressure
net airflow is flowing outward to prevent contamination of the sterile products. used for non-hazardous products
secondary engineering control
ante area and buffer area (ISO 7). aka not the primary engineering control like the laminar airflow workbench (ISO 5)
segregated compounding area
space designated for compounding with unclassified room air. if product made here then <12 h BUD
glove fingertip test
eval glove and garbing technique. 3 consecutive gloved fingertip samples with 0 CFUs for both hands. performed initially and annually for low/med risk CSPs and semi annually for high risk CSPs
media fill test
eval aseptic technique. monitor for 14 days. perform annually for low/med risk CSPs and semi-annually for high risk CSPs
clean daily
counters, work surfaces, floors
clean monthly
walls, ceiling, and storage shelves
clean freq
primary engineering control. at beginning of each shift, before and after each batch, after spills, every 30 min of continuous use, anytime contamination is suspected
how to clean
70% isopropyl alcohol (IPA) from cleanest to dirtiest areas (opposite of garbing).
human blood osmolarity
285 mosm/L
bubble point test
uses pressure to force liquid to “bubble” out of the filter 0.22 micron to test the filter integrity.
label requirements
name and amt/cond of ingred, total vol, BUD, route of admin, storage requirements, and other info for safe use
sterility testing
certain high-risk level CSPs and CSPs intended for use beyond the rec BUD require sterility testing. either tryptic soy broth or fluid thioglycollate medium, should also includ bacterial endotoxin (pyrogen) testing prior to use.
dry-heat oven sterilization
endotoxins are produced by bacteria and fungi, gram(-) bacteria have more potent endotoxins. may be present after washing stuff with tap water. avoid by rinsing with sterile water and depyrogenating dry-heat oven sterilization.
env monitoring daily
temperature
env monitoring periodically
surface sampling via tryptic soy agar. simulate dirtiest condition at end of day, then incubate. take action if >3 CFUs in ISO 5 PEC
env monitoring each shift
air pressure. each shift preferred by at minimum daily
env monitoring every 6 mo
air sampling
class 1 recall
serious adverse health consequences or death
class 2 recall
temporary or reversible adverse health consequences, probability of harm is remote.
class 3 recall
not likely to cause adverse health consequences. ex. coloring of tabs may have not been applied consistently.
CSP recalls
daily observation of incubating test specimens and immed recall if there is evid of microbial growth to all pt and MDs who received the recalled CSPs should be notified
how to garb
in ante area, don garb from dirties to cleanest. remove everything. cover shoe, head and face. (2nd cover needed for hazard drugs). hand hygiene with soap and warm water for 30 s. dry hands. don non-shedding gown. enter buffer area. apply alcohol or povidone-iodine. don gloves. sanitize gloves with 70% IPA. all garb required for isolator unless manu provides written documentation that its not required.
how to clean the hood
clean with germicidal detergent the disinfect with 70% IPA, clean from top to bottom and back to front aka cleanest to dirtiest. 1) ceiling back to front 2) grill from top to bottom. 3) side walls from back to front by wiping up and down, including IV bar and hooks. 4) bottom surface from back to front by wiping side to side. hood can remain on or turn on for at least 30 min before use.
ampule use
break away from you. use filtered needle to draw med up. use a different needle to inject into pt or something else.
visual inspection
verify the correct volume of product BEFORE personnel continue compounding to allow pharmacist to see the med in the syringe before injection (in comparison to the pull back method). after compounding, inspected for particulates, cored pieces, precipitates and cloudiness.
low CSP risk level
<3 ingred, <2 entries into 1 sterile container or device. ex. reconstitution of abx with sterile water and transferring to NS bag.
high CSP risk level
non sterile ingred and non sterile equip. ex. CSPs from bulk drug containersmed C, preparations that require sterilization and products made with non-sterile components
med CSP risk level
> 3 ingreq. complex aseptic manipulations. using multi-dose vial of abx and transferring single doses to several NS IV bags for multiple pts (batch preparation) or TPN.
BUD based on risk level: low
RT: 48h. fridge: 14 days. freezer: 45 days
BUD based on risk level: low non-HD, low/med HD <12 h BUD
RT: 12 h. fridge: 12 h
BUD based on risk level: medium
RT: 30 h. fridge: 9 days. freezer: 45 days.
BUD based on risk level: high
RT: 24 h. fridge 3 days. freezer 45 days.
BUD based on risk level: immed use
RT: 1 h.
