ch 16 sterile compounding

pg. 275-291

sterile compounding is used to prepare ______________

injections

eye drops

irrigations

pulmonary inhalations

sterile compounding follows USP _______

797

ISO rating in primary engineering control (PEC)

5

ISO rating in secondary engineering control (SEC) (buffer room)

7

ISO rating in anteroom

7 or 8

for a room with ISO 7, there must be at least _______ ACPH (air changes per hour)

30

types of primary engineering controls (PECs)

laminar airflow workbench (LAFW)

-open front

-horizontal laminar airflow

compounding aseptic isolator (CAI)

-closed front

-located in SCA (segregated compounding area)

where do you start garbing?

ante room

where are hair and face covers donned?

dirty side of the anteroom

how are shoe covers applied?

one at a time while stepping over the demarcation line

when does training need to be done for personnel that sterile compound?

initially

every 12 months

adequate aseptic technique in hand hygiene, garbing, and gloving is demonstrated by passing a garbing competency evaluation, including the __________

gloved fingertip test

adequate aseptic technique in sterile drug preparation is demonstrated by passing the ________

media-fill test

when do the gloved fingertip test and media-fill test need to be completed?

initially

every 6 months (if category 1 and 2 CSPs)

every 3 months (if category 3 CSPs)

________ means contamination is present during a media-fill test

turbidity (cloudiness)

must stay clear for 14 days after test

how often should the temperature and humidity be checked in the SEC?

once daily

how often should the temperature be checked in the CSP storage areas?

daily

air sampling for contaminants should be performed __________

every 6 months

surface sampling for contaminants should be performed _______ for all classified areas and pass-through spaces

every 30 days

areas touched most frequently should be tested ________

at the end of the compounding shift, before cleaning and disinfecting

the PEC must be on for at least ________ before compounding can begin

30 minutes

how often does the PEC need cleaned?

daily

anytime contamination is suspected

how is the PEC cleaned?

detergent

then disinfected

then sterile 70% IPA

low-lint wipes

top to bottom, back to front

how often do you need to clean and disinfect PEC, pass-through chambers, work surfaces outside PEC, and floors?

daily

how often do you need to use sporicidal disinfectant in the clean room?

monthly

how often do you need to clean and disinfect walls, doors, ceiling, storage shelves and bins, and equipment outside the PEC?

monthly

steps for garbing

1. remove coats, jewelry, makeup

2. don head and facial hair covers and face masks, then shoe covers

3. hand hygiene

   1. clean under fingernails

   2. wash hands and forearms up to elbows for 30 seconds

   3. dry hands with low-lint disposable towels or wipers

4. don a low-lint gown

   1. disposable gowns preferred

5. enter buffer area

   1. apply alcohol-based surgical hand scrub (chlorhexidine or povidone-iodine)

   2. don sterile, powder-free gloves

6. sanitize gloves with sterile 70% IPA routinely

_______ is required when withdrawing liquid from the ampule to remove the glass

filter needle or filter straw

small volume parenteral (SVP) bags/syringes can contain a volume of _______

100 mL

large volume parenteral (LVP) containers can contain a volume of _______

> 100 mL

workflow for CSP preparation

1. review the order

2. gather and inspect all materials

3. clean hood. place only needed items in hood

4. prepare CSPs with aseptic technique

5. properly dispose of syringes and needles into the sharps container

6. visually inspect all finished CSPs

7. complete terminal sterilization and/or sterility testing

where should all work within the PEC be performed?

at least 6 inches from the front

with nothing between the sterile objects and HEPA filter

how can heat-labile CSPs be sterilized?

filtration using a sterile 0.22-micron filter

what test is used to check for filter integrity?

bubble point test

endotoxins are produced by _______ bacteria and fungi

a. gram-positive

b. gram-negative

a. b.

________ can come from using equipment washed with tap water

pyrogens

where are category 1 CSPs prepared?

ISO 5 PEC that is placed in a SCA

what is the BUD for a category 1 CSP prepared in a SCA?

≤ 12 hours if unrefrigerated

≤ 24 hours if refrigerated

where are category 2 CSPs made?

cleanroom suite

what is the BUD for category 3 CSPs?

up to 180 days

if IV drugs are not made with aseptic preparation due to an emergency, what is the BUD?

4 hours

category 1, room temp BUD

12 hours

category 1, refrigerated BUD

24 hours

category 2, room temp BUD

1-45 days

category 2, refrigerated BUD

4-60 days

category 2, frozen BUD

45-90 days

category 3, room temp BUD

60-90 days

category 3, refrigerated BUD

90-120 days

category 3, frozen BUD

120-180 days

label requirements for CSPs

names and amounts/concentrations of ingredients

total volume

BUD

dosage form

ROA

storage requirements

internal identification number