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Pharm Tech > STERILE DOSAGE FORMS > Flashcards

STERILE DOSAGE FORMS Flashcards

1
Q

What is the greatest source of contamination when discussing sterility?

A

The person working on the product.

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2
Q

Name 5 types of Compounded Sterile Products

A 
PCA (Patient Controlled Analgesia)
Cardioplegia
Inhalation
TPN
Ophthalmic Drops
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3
Q

List 3 Infusion types of Compounded Sterile Products

A

Small Volume Infusions
Large Volume Infusions
Hazardous Drug Infusions (ie, chemotherapy)

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4
Q

The process of assuring sterility through our procedures is called:

A

Aseptic Technique

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5
Q

Syringes are made to hold volumes from ___ml - __ ml

A

0.5ml - 50ml

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6
Q

True or False

When selecting needles, the larger the gauge needle, the thicker the needle.

A

False

Larger gauge needle = thinner needle

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7
Q

In order to maintain sterility of a syringe, which of the following rules must be followed:

a) The needle should never be touched to anything unsterile.
b) The syringe should never touch anything but the hub of the needle.
c) The portion of the plunger which extends into the syringe should never be touched.
d) Only the outer barrel and tip of the plunger should be touched by the operator.

A

a, b, c, d

a) The needle should never be touched to anything unsterile.
b) The syringe should never touch anything but the hub of the needle.
c) The portion of the plunger which extends into the syringe should never be touched.
d) Only the outer barrel and tip of the plunger should e touched by the operator.

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8
Q

True or False
Once the plunger has been extended to draw up medication, it has been exposed to the environment, which can contaminate the barrel if drawn back again.

A

True

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9
Q

Where should the syringe and needle be disposed after usage?

A

Biohazard sharps containers.

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10
Q

By trying to replace the needle cover, you:

A

Expose yourself to a possible needle stick.

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11
Q

What is a common occurrence during insertion of the needle into the rubber stoppers of medication bottle or IV bags?

A

Coring

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12
Q

How should a needle be inserted into a rubber stopper to avoid coring?

A

Bevel side up, 45° angle

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13
Q

What is USP and what is it known for?

A

USP = United States Pharmacopeia

Establishing standards for compounding.

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14
Q

What is the section of the USP/NF that covers compounded sterile products (CSP)?

A

USP Chapter 797 - Compounding Sterile Products

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15
Q

What is the goal of USP 797?

A

Lay out standards for CSP preparation.

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16
Q

The purpose of USP 797 is to prevent harm and fatality to patients resulting from:

A

Microbial contamination, incorrect ingredient strength and usage errors.

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17
Q

Goals of USP 797 include preventing harm and death to patients resulting from which of the following?

a) Microbial contamination
b) Excessive bacterial endotoxins
c) Variable strength of correct ingredients
d) Unintended chemical and physical contaminants
e) Inappropriate ingredient quality

A

a, b, c, d, e

a) Microbial contamination
b) Excessive bacterial endotoxins
c) Variable strength of correct ingredients
d) Unintended chemical and physical contaminants
e) Inappropriate ingredient quality

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18
Q

USP 797 is an all-encompassing rule which covers:

A

Equipment, technicians, and quality control of sterile product preparation.

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19
Q

With a Risk Level Assessment, the higher the risk rating, the ____ safeguards that should be in place.

A

more

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20
Q

The first requirement in compounding sterile products is having:

A

A clean environment housing a laminar flow hood(s).

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21
Q

Working room containing the flow hoods:

A

the Clean Room

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22
Q

Another room at the entry of the clean room:

A

Ante-area

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23
Q

The ante-area houses:

A

Supplies, gowns, sink, etc.

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24
Q

The clean room houses:

A

Equipment and is where actual preparation of sterile product is performed.

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25
Q

The buffer area is required in facilities that compound ______________ risk CSP’s.

A

medium-high

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26
Q

The clean room, ante-area, and buffer area have regulated primary engineering controls to maintain standard:

A

Air quality and Air Pressure
Temp
Humidity

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27
Q

Anyone who is not involved or trained in sterile product preparation is ___ _____to the clean room, ante-area, and buffer area.

A

off limits

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28
Q

The air pressure of each of the following areas gradually gets higher in what order?

a) ante-area
b) buffer area
c) critical area
d) pharmacy
e) clean room

A

d, b, a, e, c

pharmacy -> buffer area -> ante-area -> clean room -> critical area

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29
Q

Air pressure helps push ____________ out from the cleaner area as we open doors between areas.

A

contaminants

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30
Q

What does ISO stand for?

A

International Organization for Standardization

31
Q

How does ISO measure air/environmental cleanliness?

A

By # of contaminants in the air per cubic meter of air.

32
Q

Match the corresponding USP 797 standards established for air quality with the correct ISO classes listed: Class 5, Class 5 + 1st Air, Class 7, Class 8

a) Clean Room
b) Critical Areas
c) Ante-Area
d) Direct Compounding Area

A

a) Class 7
b) Class 5
c) Class 8
d) Class 5 Plus First Air

33
Q

What is the purpose of the Horizontal Laminar Air Flow Workbench (aka Hood or Clean Bench)?

A

Blow filtered air across work area to prevent contaminated room air from entering the work field.

34
Q

Describe in order the way a Horizontal Laminar Air Flow Workbench filters air.

a) Sent through a series of blowers
b) Sent horizontally across the work field
c) Room air brought in through top
d) Routed through the filter in back of work area

A

c) Room air brought in through top
a) Sent through a series of blowers
d) Routed through the filter in back of work area
b) Sent horizontally across the work field

35
Q

What is the name of the filter used for a Laminar Flow Workbench?

A

HEPA filter

36
Q

HEPA stands for:

A

High Efficiency Particulate Air

37
Q

The purpose of a HEPA filter is:

A

To catch and retain airborne particles and microorganisms.

38
Q

What percentage of particles 0.3 microns or larger will a properly operating pharmacy HEPA filter remove?

A

99.997%

39
Q

What was the issue with the Horizontal Laminar Clean Bench?

A

Any spilled or aerosolized drug was blown in operators face.

40
Q

What are the advantages of using a Vertical Laminar Clean Bench over a Horizontal Laminar Clean Bench?

A

It blows air downwards, decreasing chemical exposure risk.

41
Q

Describe in order the way in which a Vertical Laminar Clean Bench operates.

a) Air is re-filtered and reused
b) Air is collected from the bottom of the workspace from inlet duct
c) Air is directed straight down on workspace
d) HEPA filter delivers air from the top

A

d) HEPA filter delivers air from the top
c) Air is directed straight down on workspace
b) Air is collected from the bottom of the workspace from inlet duct
a) Air is re-filtered and reused

42
Q

Newer hoods have been developed for when working with hazardous drugs. They are called:

A

Biological Safety Cabinets

43
Q

How are Biological Safety Cabinets different than Horizontal or Vertical Laminar Clean Benches?

A

They exhaust air flow through an additional HEPA filter at the cabinets exhaust duct.

44
Q

There are 3 Classes of BSCs. Which class is the incoming air not filtered, so it is not suitable for use in sterile compounding?

a) Class I
b) Class II
c) Class III

A

a) Class I

45
Q

There are 3 Classes of BSCs. Which class is divided into 3 categories and are suitable for sterile product production?

a) Class I
b) Class II
c) Class III

A

b) Class II

46
Q

There are 3 Classes of BSCs. Which class is totally enclosed, leak proof, and is used only when there is immediate risk to the operator from the product at hand?

a) Class I
b) Class II
c) Class III

A

c) Class III

47
Q

What are the 3 categories of Class II?

A

A2, B1, and B2

48
Q

What is the air inflow/air exhausted ratio for category A2 of a Class II BSC?

A

70% in / 30% exhaust

49
Q

What is the air inflow/air exhausted ratio for category B1 of a Class II BSC?

A

30% in / 70% exhaust

50
Q

What is the air inflow/air exhausted ratio for category B2 of a Class II BSC?

A

0% in / 100% exhaust

51
Q

What is an Isolator?

A

Another unit that uses pressure to keep out contaminants.

52
Q

How is an Isolator different from a Class III BSC?

A

Uses pressure instead of pass thru chambers to keep contaminants out.

53
Q

A new filter design making its way into the BSC product line is called the:

A

Ultra-Low Particulate Air Filter (ULPA Filter)

54
Q

What is the difference between the HEPA and ULPA filters?

A

ULPA: removes 99.999% of particles 0.12 microns or larger in diameter
HEPA: 99.997% of particles 0.3 microns or larger

55
Q

List the equipment required to work in a sterile environment.

A

Scrubs, shoe/hair covers, face mask, hand washing facility, sterile gown/gloves, foaming isopropyl alcohol hand sterilizer.

56
Q

List in order the proper method of preparation for working in a sterile environment.

a) Hair Cover -> Face Mask
b) Scrubs -> Shoe Covers
c) Sterile Gown-> Sterile Gloves
d) Wash Hands -> Sterilize Hands

A

b) Scrubs -> Shoe Covers
a) Hair Cover -> Face Mask
d) Wash Hands -> Sterilize Hands
c) Sterile Gown-> Sterile Gloves

57
Q

At minimum, cleaning should be done:

a) When any spills occur
b) Before each batch
c) At the beginning of each shift
d) Every hour while compounding

A

a) When any spills occur
b) Before each batch
c) At the beginning of each shift

58
Q

Floors of ante-area and clean room should cleaned:

a) Once weekly
b) Once daily
c) Twice daily

A

b) Once daily

59
Q

Walls, ceilings, and storage shelving of ante-area and clean room should be cleaned:

a) Once weekly
b) Once daily
c) Once monthly

A

c) Once monthly

60
Q

Anytime you are compounding chemotherapy CSPs or working with hazardous compounds, you should be using equipment that provides a (positive/negative)_________ internal pressure and has its exhaust vented (inside/outside) _______.

A

negative

outside

61
Q

The HEPA filter should be checked every _ months.

A

6

62
Q

Are IV administration sets interchangeable between machines?

A

No

63
Q

IV Admin Sets: The tube with a white pointed end is:

a) the drip chamber
b) inserted into the administration port in the IV bag
c) the pump connection

A

b) inserted into the administration port in the IV bag

64
Q

IV Admin Sets: The part that manually calculates the flow rate is:

a) inserted into the administration port in the IV bag
b) the pump connection
c) the drip chamber

A

c) the drip chamber

65
Q

IV Admin Sets: The valve that incrementally pinches off the tubing controlling flow is:

a) the manual control valve
b) the drip chamber
c) the administration port

A

a) the manual control valve

66
Q

IV Admin Sets: The administration set part that attaches to the IV pump is:

a) the administration port
b) the manual control valve
c) the pump connection

A

c) the pump connection

67
Q

IV Admin Sets: The administration part that attaches to the IV port at the patient is:

a) the manual control valve
b) the administration port
c) inserted into the administration port in the IV bag

A

b) the administration port

68
Q

IV filtration removes microorganisms and particles that are larger than:

a) 0.22 microns
b) 0.02 microns
c) 0.20 microns

A

a) 0.22 microns

69
Q

PPE is helpful in protecting the:

a) patient
b) worker
c) both
d) neither

A

c) both

70
Q

Oozing is noticed on the HEPA filter in your hood. You should:

a) spray the filter with alcohol
b) wipe the area with a sterile, lint free cloth
c) inform the pharmacist immediately
d) all of the above

A

c) inform the pharmacist immediately

71
Q

What Part of a patient’s Medicare coverage pays for prescription drugs?

a) Part A
b) Part B
c) Part C
d) Part D

A

d) Part D

72
Q

A class II recall is appropriate when the risk of serious injury or death is:

a) likely
b) certain
c) unlikely
d) none of the above

A

d) none of the above

73
Q

The compounding of non-sterile products is regulated by:

a) CSA 345
b) FDA 975
c) USP 795
d) UPS 797

A

c) USP 795

74
Q

According to USP 797, the air quality inside the laminar flow hood must be:

a) ISO Class 1
b) ISO Class 5
c) ISO Class 7
d) ISO Class 8

A

b) ISO Class 5

Pharm Tech (29 decks)

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