United States Pharmacopeia: Pharmaceutical Compound-Sterile Preparations Pt 3 Flashcards
(13 cards)
A ____ is more than one unit of a product compounded in a single process
Batch
A ____ (BUD) is the date and time at which a compound-sterile preparation (CSP) must be discarded and cannot be used any longer
Beyond-use date
What is a CSP?
compound-sterile preparation
What is a Category 1 CSP (Compound-sterile preparation)?
This is a CSP (Compound-sterile preparation) which has been assigned a Beyond-use date (BUD) of 12 hours or less at room temperature or 24 hours or less refrigerated
What is a Category 2 CSP (Compound-sterile preparation)?
This is a CSP (Compound-sterile preparation) which has been assigned a Beyond-use date (BUD) of greater than 12 hours at room temperature or greater than 24 hours refrigerated.
A ____ (COA) is a report provided by manufacturer or suppliers to indicate specifications and results of testing for the item
Certificate of Analysis
A ____ is a process simulating compounding processes or products to ensure that microbial growth is not present
Media fill test
A ____ is a substance used to prevent microbial growth
Preservative
____-free is a substance that lacks fever inducing toxins
Pyrogen-free
____ testing is testing that ensures a product meets required quality characteristics
Release testing
A ____ area (SCA) is a designed space, that contains a primary engineering control (PEC) where category 1 compounds can be prepared
segregated compounding area
What does PEC mean?
Primary engineering control
____ is a concentrated agent that destroys bacterial and fungal spores when used in a specific time period
Sporicidal
