USP 797 part 2 Flashcards Preview

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Flashcards in USP 797 part 2 Deck (13)
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1
Q

hood surfaces should be cleaned

A

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

2
Q

deep cleaning

A
  • at least monthly

- storage shelving, walls, ceiling

3
Q

garbing of PPE and cleaning sequence

A
shoe covers
facial hair covers & face mask 
hair cover
eye shields
wash hands
non-shedding gowns
alcohol hands
gloves
4
Q

all personnel must pass ___ glove fingertip sampling before compounding CSP

A

3

5
Q

most likely source of contamination

A

touch contamination

6
Q

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

A

no

- provides false negatives

7
Q

surface samlping

A

in all ISO areas

8
Q

sterility testing

A

in all high risk CRPs

9
Q

sterility methods

A

filtration
steam
dry heat

10
Q

filtration

A

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

11
Q

steam

A

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

12
Q

dry heat

A

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

13
Q

current TSBP sterile compounding requirements

A
  • 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)