Beyond Use Dating (Kirk)
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43 Terms
What is the beyond-use date?
The date, or hour and the date, after which a CSP must not be used, stored, or transported
______________ is the time during which a product maintains expected quality
Expiration
______________-_______ ____________ is the date after which CSP must not be used, stored, or transported
Beyond Use Date
Who is the expiration date assigned by?
Manufacturer
Who is beyond-use date assigned by?
Pharmacy
Who is hang-time or infusion-time assigned by?
Nursing
Who is in-use time assigned by?
Manufacturer
The __________-_________ is the available length of time for an infusion to be used before it must be taken down
Hang-time
(Infusion-time)
The _______-________ time is the maximum amount of time a vial can be used after initial manipulation
In-Use
_____________ is the extent to which a product retains physiochemical properties through its expiration date
Stability
_____________ is the complete absence of microorganisms
Sterility
True or False: an immediate use product is more sterile than a Category 3 product
False
What is USP 71 concerned with?
Sterility Testing
What are the different methods for sterilization? (2)
1. Aseptic Sterilization
2. Terminal Sterilization
Aseptic ______________ use sterile products and equipment, while aseptic ____________________ uses sterile OR nonsterile ingredients
Technique, Filtration
What is the important component of aseptic filtration?
0.22 micron or smaller filter
True or False: terminal sterilization only uses sterile ingredients
False: terminal sterilization uses sterile OR nonsterile ingredients
What is the BUD of immediate use products?
4 Hours
What is the BUD of a Category 1 CSP being kept at CRT?
≤12 hours
What is the BUD of a Category 1 CSP being kept in the refrigerator?
≤24 hours
What is the BUD of a Category 2 CSP being kept at CRT containing at least one nonsterile product?
(No sterility testing)
1 day
What is the BUD of a Category 2 CSP being kept in the refrigerator containing at least one nonsterile products?
(No sterility testing)
4 days
What is the BUD of a Category 2 CSP being kept in the freezer containing at least one nonsterile product?
(No sterility testing)
45 days
What is the BUD of a Category 2 CSP being kept at CRT containing all sterile products?
(No sterility testing)
4 days
What is the BUD of a Category 2 CSP being kept in the refrigerator containing all sterile products?
(No sterility testing)
10 days
What is the BUD of a Category 2 CSP being kept in the freezer containing all sterile products?
(No sterility testing)
45 days
If a Category 2 CSP did NOT undergo sterility testing, but DID undergo terminal sterilization, what is it's BUD at CRT?
14 days
If a Category 2 CSP did NOT undergo sterility testing, but DID undergo terminal sterilization, what is it's BUD in the refrigerator?
28 days
If a Category 2 CSP did NOT undergo sterility testing, but DID undergo terminal sterilization, what is it's BUD in the freezer?
45 days
If a Category 2 CSP did undergo sterility testing, but did NOT undergo terminal sterilization, what is it's BUD at CRT?
30 days
If a Category 2 CSP did undergo sterility testing, but did NOT undergo terminal sterilization, what is it's BUD in the refrigerator?
45 days
If a Category 2 CSP did undergo sterility testing, but did NOT undergo terminal sterilization, what is it's BUD in the freezer?
60 days
If a Category 2 CSP did undergo sterility testing, and did undergo terminal sterilization, what is it's BUD at CRT?
45
If a Category 2 CSP did undergo sterility testing, and did undergo terminal sterilization, what is it's BUD in the refrigerator?
60 days
If a Category 2 CSP did undergo sterility testing, and did undergo terminal sterilization, what is it's BUD in the freezer?
90 days
True or False: all Category 3 CSPs must undergo sterility testing
True
True or False: all Category 2 CSPs must undergo sterility testing
False: they MAY undergo sterility testing
If a Category 3 CSP did NOT undergo terminal sterilization, what is its BUD at CRT?
30 days
If a Category 3 CSP did NOT undergo terminal sterilization, what is its BUD in the refrigerator?
45 days
If a Category 3 CSP did NOT undergo terminal sterilization, what is its BUD in the freezer?
60 days
If a Category 3 CSP DID undergo terminal sterilization, what is its BUD at CRT?
45 days
If a Category 3 CSP DID undergo terminal sterilization, what is its BUD in the refrigerator?
60 days
If a Category 3 CSP DID undergo terminal sterilization, what is its BUD in the freezer?
90 days