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United States Pharmacopeia: Pharmaceutical Compound-Sterile Preparations Pt 3 Flashcards

(13 cards)

1
Q

A ____ is more than one unit of a product compounded in a single process

A

Batch

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2
Q

A ____ (BUD) is the date and time at which a compound-sterile preparation (CSP) must be discarded and cannot be used any longer

A

Beyond-use date

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3
Q

What is a CSP?

A

compound-sterile preparation

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4
Q

What is a Category 1 CSP (Compound-sterile preparation)?

A

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

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5
Q

What is a Category 2 CSP (Compound-sterile preparation)?

A

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.

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6
Q

A ____ (COA) is a report provided by manufacturer or suppliers to indicate specifications and results of testing for the item

A

Certificate of Analysis

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7
Q

A ____ is a process simulating compounding processes or products to ensure that microbial growth is not present

A

Media fill test

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8
Q

A ____ is a substance used to prevent microbial growth

A

Preservative

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9
Q

____-free is a substance that lacks fever inducing toxins

A

Pyrogen-free

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10
Q

____ testing is testing that ensures a product meets required quality characteristics

A

Release testing

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11
Q

A ____ area (SCA) is a designed space, that contains a primary engineering control (PEC) where category 1 compounds can be prepared

A

segregated compounding area

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12
Q

What does PEC mean?

A

Primary engineering control

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13
Q

____ is a concentrated agent that destroys bacterial and fungal spores when used in a specific time period

A

Sporicidal

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