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Parenterals Midterm > Week 3 > Flashcards

Week 3 Flashcards

1
Q

Define US Pharmacopeia

A

Established standards for the identity, strength, quality and purity of meds, food ingredients and dietary supplements

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2
Q

Who enforces the US Pharmacopeia?

A

FDA

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3
Q

Define Chapter 797

A

Compounding sterile products

= Set standards that are applicable to all places that prepare sterile products

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4
Q

Purpose of the 797

A

To protect the health of pts by reducing contamination possibilities

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5
Q

States indirect mean:

A

Do not specifically site USP 797 but there are laws and regulation for sterile compounding

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6
Q

797 includes:

A 
Garbing requirements
Hand washing
Room requirements
Training
Cleaning
Testing of the environment
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7
Q

Define International Organization of Standardization (ISO)

A

Ensure that products and services are safe, reliable and of good quality

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8
Q

ISO 5 Particle limit

A

3520

~100 ft^3

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9
Q

ISO 7 Particle Limit

A

352000

~10000 ft^3

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10
Q

ISO 8 Particle Limit

A

3,520,000

~ 100,000 ft^3

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11
Q

ISO Class 5 is required where?

A

LAFW, biological safety cabinet, compounding aseptic containment isolator, compounding aseptic isolator
HEP filtered unidirectional airflow
Hoods

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12
Q

ISO Class 7 is required where?

A

Buffer room

Hood room

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13
Q

ISO Class 7 is required where?

A

Ante area
Where you waash your hands and put on PPE
Clean supplies

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14
Q

What do you see in the Ante area?

A

Sink
Supplies
Hand dryer/paper towels

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15
Q

What do you do in the Ante area?

A

Wash hands and put on garb

Open and clean supplies

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16
Q

What do you see in buffer area?

A

Smooth and continuous surfaces
No sinks, drains, outer doors, opening windows
Hoods, minimal supplies and pumps
Control of humidity, temperature, pressure

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17
Q

Buffer areas should have _____ pressure which ___________.

A

Positive; pushes air out of the room

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18
Q

Unless ___________ then it has to have negative pressure.

A

Chemo buffer room

19
Q

What do you do in the buffer area?

A

Prepare for compounding

20
Q

What do you see in the Hood?

A 
Easily cleanable surfaces
Minimal supplies
Light/UV light
Pole with hooks
Electric plugs
Filter
21
Q

What do you do in the hood?

A

Compound

22
Q

Risk level is assigned according to the probability of contaminating a compounded with:

A

Microbial contaminants

Physical and chemical contaminants

23
Q

Low Risk Max Room Temp

A

48 hours

24
Q

Low Risk Max Refrigerated

A

14 days

25
Q

Low Risk Max Frozen

A

45 days

26
Q

Low risk requirements

A

ISO class 5 within an ISO class 7 with an ISO class 8 ante area
<2 entries
Annual media fill test

27
Q

Low Risk </= 12 hours Requirement

A 
ISO Class 5
Nonhazardous
Admin is no later than 12 hours after
Segregated compounding area
Cleansing and garb required
28
Q

Medium Risk room temp

A

30 hours

29
Q

Medium Risk refrigerated

A

9 days

30
Q

Medium Risk frozen

A

45 days

31
Q

Medium Risk Requirements

A

> 3 sterile products
2 entries
Annual Media Fill-Test

32
Q

High Risk Requirements

A

Nonsterile

Biannual Media Fill Test

33
Q

High Risk room temp

A

24 hrs

34
Q

High risk refrigerated

A

3 days

35
Q

High risk frozen

A

45 days

36
Q

Immediate use requirements

A

<1 hr after making

37
Q

Single dose BUD

A

1 hr if not in hood

6 hr if in hood

38
Q

Multiple-dose containers BUD

A

28 days

39
Q

Define Hazardous Drug

A

Chemo or any IV drug that may put the compounding personnel at risk
Stored separate in well ventilated area (12 air changes per hour)

40
Q

Hazardous Drugs Buffer area vs ante

A 
ISO class 7 with negative pressure
ISO class 8 with positive pressure
41
Q

Personnel must be trained in

A

Safe aspetic manipulation
Negative pressure techniques
Correct use of closed system vial transfer device
Containment, cleanup and disposal for spills and breakage
Treatment of personnel contact and inhalation

42
Q

Re-certification of facilities and equipment and nonviable air sampling occurs?

A

Every 6 months

43
Q

Must also do

A

Viable air sampling and have a pressure gauge

Parenterals Midterm (8 decks)

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