Ch 5: Sterile Compounding

Question 1

ISO air quality

Answer 1

international standards organization (ISO) determined by #particles per volume of air of a specified particle size. lower the count, cleaner the air.

Question 2

ISOs of common areas

Answer 2

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.

Question 3

HEPA filters

Answer 3

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)

Question 4

air changes per hour (ACPH)

Answer 4

rate at which the air is vented to outside. 30 ACPH required for primary engineering control

Question 5

biological safety cabinet (BSC)

Answer 5

aka chemo hood, neg pressure hood used to prepare hazardous CSP

Question 6

isolators

Answer 6

glove boxes, type of primary engineering control completely enclosed. can be pos pressure for nonhazard drugs or neg pressure for hazard drugs.

Question 7

laminar airflow workbench or laminar airflow hood

Answer 7

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.

Question 8

line of demarcation

Answer 8

line separating 2 diff areas, usually separating the ante area and buffer area

Question 9

neg pressure

Answer 9

new airflow is flowing in, to protect staff from toxic fumes, air is vented to outside. required for hazardous drugs

Question 10

pos pressure

Answer 10

net airflow is flowing outward to prevent contamination of the sterile products. used for non-hazardous products

Question 11

secondary engineering control

Answer 11

ante area and buffer area (ISO 7). aka not the primary engineering control like the laminar airflow workbench (ISO 5)

Question 12

segregated compounding area

Answer 12

space designated for compounding with unclassified room air. if product made here then <12 h BUD

Question 13

glove fingertip test

Answer 13

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

Question 14

media fill test

Answer 14

eval aseptic technique. monitor for 14 days. perform annually for low/med risk CSPs and semi-annually for high risk CSPs

Question 15

clean daily

Answer 15

counters, work surfaces, floors

Question 16

clean monthly

Answer 16

walls, ceiling, and storage shelves

Question 17

clean freq

Answer 17

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

Question 18

how to clean

Answer 18

70% isopropyl alcohol (IPA) from cleanest to dirtiest areas (opposite of garbing).

Question 19

human blood osmolarity

Answer 19

285 mosm/L

Question 20

bubble point test

Answer 20

uses pressure to force liquid to “bubble” out of the filter 0.22 micron to test the filter integrity.

Question 21

label requirements

Answer 21

name and amt/cond of ingred, total vol, BUD, route of admin, storage requirements, and other info for safe use

Question 22

sterility testing

Answer 22

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.

Question 23

dry-heat oven sterilization

Answer 23

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.

Question 24

env monitoring daily

Answer 24

temperature

Question 25

env monitoring periodically

Answer 25

surface sampling via tryptic soy agar. simulate dirtiest condition at end of day, then incubate. take action if >3 CFUs in ISO 5 PEC

Question 26

env monitoring each shift

Answer 26

air pressure. each shift preferred by at minimum daily

Question 27

env monitoring every 6 mo

Answer 27

air sampling

Question 28

class 1 recall

Answer 28

serious adverse health consequences or death

Question 29

class 2 recall

Answer 29

temporary or reversible adverse health consequences, probability of harm is remote.

Question 30

class 3 recall

Answer 30

not likely to cause adverse health consequences. ex. coloring of tabs may have not been applied consistently.

Question 31

CSP recalls

Answer 31

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

Question 32

how to garb

Answer 32

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.

Question 33

how to clean the hood

Answer 33

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.

Question 34

ampule use

Answer 34

break away from you. use filtered needle to draw med up. use a different needle to inject into pt or something else.

Question 35

visual inspection

Answer 35

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.

Question 36

low CSP risk level

Answer 36

<3 ingred, <2 entries into 1 sterile container or device. ex. reconstitution of abx with sterile water and transferring to NS bag.

Question 37

high CSP risk level

Answer 37

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

Question 38

med CSP risk level

Answer 38

>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.

Question 39

BUD based on risk level: low

Answer 39

RT: 48h. fridge: 14 days. freezer: 45 days

Question 40

BUD based on risk level: low non-HD, low/med HD <12 h BUD

Answer 40

RT: 12 h. fridge: 12 h

Question 41

BUD based on risk level: medium

Answer 41

RT: 30 h. fridge: 9 days. freezer: 45 days.

Question 42

BUD based on risk level: high

Answer 42

RT: 24 h. fridge 3 days. freezer 45 days.

Question 43

BUD based on risk level: immed use

Answer 43

RT: 1 h.