PHM 250 LAB: Midterm Review Questions with
Correct Solutions
How often must a sterile compounding personnel who have direct oversight of
compounding personnel, demonstrate knowledge and competency of core skills
(handwashing, ?
1. After initial training 2. Yearly
In order to demonstrate initial competency with hand hygiene and garbing procedures,
personnel must successfully complete an initial garbing competency evaluation followed by
_____________ on each hand a minimum of ______ separate times with no microbial
growth before being allowed to independently prepare CSPs.
Gloved fingertip and thumb sampling (GFT) , 3
Sterile Compounding Personnel must be observed by the designated individual or trainer
initially and at least every ____ months while performing hand hygiene and garbing
procedures.
Six
For personnel compounding Category 1 or 2 CSPs, ongoing media fill testing must be
performed ________.
Every 6 months
How often must sterile compounding personnel complete ongoing, post -gloved fingertip
and thumb sampling (GFT)?
Category 1 & 2 compounders - every 6 months ; Category 3 compounders - every 3 months
, The maximum batch size for all CSPs requiring sterility testing is limited to ________ final
yield units.
250
A multiple-dose CSP prepared as a Category 2 or 3 CSP, that passes antimicrobial
effectiveness testing per USP , is good for how long after initially punctured? No longer
than the assigned BUD or ________ days, whichever is shorter.
28
What is the BUD for a multiple-dose aqueous, nonpreserved CSP intended for topical
ophthalmic administration if prepared as Category 2 or 3 and intended for use by a single
patient?
24 hours at room temperature ; 72 hours if refrigerated after opening
True or False: Maintaining testing results and records related to microbiological
identification for microbiological air and surface sampling is required only if results are
out of limits.
False
CSPs that must meet the requirement of the USP 797 chapter to ensure sterility include ...
Injections including infusions , Irrigations for internal body cavities , Ophthalmic dosage forms
The ______________ _________ is responsible for the operation of the facility and
performance of personnel related to CSPs.
Designated Person
Correct Solutions
How often must a sterile compounding personnel who have direct oversight of
compounding personnel, demonstrate knowledge and competency of core skills
(handwashing, ?
1. After initial training 2. Yearly
In order to demonstrate initial competency with hand hygiene and garbing procedures,
personnel must successfully complete an initial garbing competency evaluation followed by
_____________ on each hand a minimum of ______ separate times with no microbial
growth before being allowed to independently prepare CSPs.
Gloved fingertip and thumb sampling (GFT) , 3
Sterile Compounding Personnel must be observed by the designated individual or trainer
initially and at least every ____ months while performing hand hygiene and garbing
procedures.
Six
For personnel compounding Category 1 or 2 CSPs, ongoing media fill testing must be
performed ________.
Every 6 months
How often must sterile compounding personnel complete ongoing, post -gloved fingertip
and thumb sampling (GFT)?
Category 1 & 2 compounders - every 6 months ; Category 3 compounders - every 3 months
, The maximum batch size for all CSPs requiring sterility testing is limited to ________ final
yield units.
250
A multiple-dose CSP prepared as a Category 2 or 3 CSP, that passes antimicrobial
effectiveness testing per USP , is good for how long after initially punctured? No longer
than the assigned BUD or ________ days, whichever is shorter.
28
What is the BUD for a multiple-dose aqueous, nonpreserved CSP intended for topical
ophthalmic administration if prepared as Category 2 or 3 and intended for use by a single
patient?
24 hours at room temperature ; 72 hours if refrigerated after opening
True or False: Maintaining testing results and records related to microbiological
identification for microbiological air and surface sampling is required only if results are
out of limits.
False
CSPs that must meet the requirement of the USP 797 chapter to ensure sterility include ...
Injections including infusions , Irrigations for internal body cavities , Ophthalmic dosage forms
The ______________ _________ is responsible for the operation of the facility and
performance of personnel related to CSPs.
Designated Person
