USP 797 part 2

Question 1

hood surfaces should be cleaned

Answer 1

beginning at each work shift
prior to each batch
every 30 minutes during prolonged compounding
during heavy surface contamination

Question 2

deep cleaning

Answer 2

• at least monthly

- storage shelving, walls, ceiling

Question 3

garbing of PPE and cleaning sequence

Answer 3

shoe covers
facial hair covers & face mask 
hair cover
eye shields
wash hands
non-shedding gowns
alcohol hands
gloves

Question 4

all personnel must pass ___ glove fingertip sampling before compounding CSP

Answer 4

3

Question 5

most likely source of contamination

Answer 5

touch contamination

Question 6

in fingertip testing, do you disinfection with alcohol after donning gloves?

Answer 6

no

- provides false negatives

Question 7

surface samlping

Answer 7

in all ISO areas

Question 8

sterility testing

Answer 8

in all high risk CRPs

Question 9

sterility methods

Answer 9

filtration
steam
dry heat

Question 10

filtration

Answer 10

sterile filters
pore size of 0.2-0.22mcm
product must be chemically & physically compatible with sterile membrane filter

Question 11

steam

Answer 11

autoclave
preferred method to sterilize aq preparations
materials are exposed to steam at 121*C for 20-60 minutes
solutions are filtered through 1.2mcm filter prior to steam

Question 12

dry heat

Answer 12

used when moisture will damage material or it is impermeable
uses heat filtered air that is evenly distributed throughout the chamber by a blower
requires higher temps & longer exposure than steam

Question 13

current TSBP sterile compounding requirements

Answer 13

• pass written & skills test on the job & ACPE approved program
• 20 hours training for pharmacist
• 40 hours training for tech
• annual validation for low & medium risk
• semi-annual for high risk
• 6 hours of ACPE approved CE Q 2 years related to sterile product compounding (4 for high risk)