Lecture Flashcards

1
Q

What is the definition of compounded sterile product?

A

a sterile drug or nutrient prepared in a licensed pharmacy or other healthcare-related facility pursuant to the order of the licensed prescriber

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2
Q

To which entities does USP 797 apply?

A

institutions, pharmacies, and facilities that prepare, store, and dispense CSP’s

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3
Q

Which USP chapters are enforcable?

A

all < 1000

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4
Q

What is the purpose of USP Chapter 797?

A

prevent harm and increase regulation coverage

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5
Q

What are the 5 possible risk categories of CSPs?

A

immediate use, low w/ 12h BUD, low, medium, hi

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6
Q

What types of CSPs fall into the immediate use category exemption?

A

intended for emegency and used within 1 hour; normally low-risk

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7
Q

What are environment requirements for risk levels?

A

ISO Class 7 cleanroom w/ ante area; ISO Class 5 LAFW

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8
Q

What CSPs fall into low-risk category?

A

simple transfers & reconstitutions; no more than 3 sterile products and 2 entries

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9
Q

What CSPs receive the low-risk w/ 12h BUD classification?

A

LAFW not in ISO Class 7 cleanroom; low-risk products only

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10
Q

What CSPs receive medium risk level?

A

multiple additives or small volumes or long duration of prep; batching

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11
Q

What CSPs receive high-risk level?

A

nonsterile ingredients or improper garbing or anything sterile and non-preserved exposed to < ISO 5 air for > 1 hour

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12
Q

What is the definition of BUD?

A

date or time after which CSPs should not be stored or transported

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13
Q

Low level BUDs:

A

48h @ RT, 14d fridge, 45d freezer

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14
Q

Medium level BUDs:

A

30h @ RT, 9d fridge, 45d freezer

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15
Q

High level BUDs:

A

24h @ RT, 3d fridge, 45d freezer

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16
Q

Describe handwashing procedure.

A

Scrub to the elbow with appropriate cleanser for > 30s

17
Q

What is contained in the buffer zone?

A

hood, cart, (counter?)

18
Q

what does HEPA stand for?

A

high-efficiency particulate air (HEPA) filter

19
Q

what is the critical site?

A

the area between HEPA & CSP

20
Q

what is the zone of turbulence?

A

turbulent air created by any object interrupting first air to the critical site

21
Q

how large is the zone of turbulence?

A

3x the diameter of the interfering object

22
Q

How often is a hood certified?

A

every 6 months

23
Q

What are the 2 most critical aspects of aseptic technique?

A

proper handwashing & proper syringe/needle manipulation

24
Q

what are the components of the needle

A

shaft and hub

25
Q

what is improper needle insertion called?

A

coring