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OU Practice Spring 2018 > Compounded Sterile Product (CSP) > Flashcards

Compounded Sterile Product (CSP) Flashcards

1
Q

ISO classes value and relation to sterility

A

the lower the number, the cleaner the air

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2
Q

What is the ante area’s ISO class?

A

Class 8

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3
Q

What is the buffer area’s ISO class?

A

Class 7

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4
Q

What can you do in an ante area?

A
  • For personnel hand hygiene/garbing
  • Staging of compounding materials
  • Order entry and CSP labeling
  • Maintains pressure relationships to adjacent rooms
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5
Q

What can you do in a bugger area?

A
  • Staging of components and supplies for compounding CSPs

- The location of the primary engineering control (PEC) for compounding

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6
Q

Where is the PEC located?

A

in the buffer area

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7
Q

What is the purpose of maintaining pressure relationships established in the ante area?

A

clean air must move towards dirty air which is maintained by pressure gradients

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8
Q

What is a clean room’s ISO class?

A

Class 5

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9
Q

Direction of airflow for positive pressure

A
  • pressure flows out to the dirtier areas

- ex. ISO 5 -> ISO 7 -> ISO 8

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10
Q

What is the ISO class for a PEC?

A
  • primary engineering control

- ISO class 5

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11
Q

What are the features of a segregated compounding area?

A
  • Designated demarcated space or room
  • Contains a primary engineering control which produces ISO Class 5 air quality
  • Only includes activities/materials specific to CSP preparation (no general traffic)
  • Only low-risk CSPs with beyond-use date (BUD) of < 12 hours
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12
Q

How often should the walls, ceilings, and storage shelves be cleaned?

A

monthly

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13
Q

How often should the counters, work surfaces, and floors be cleaned?

A

daily

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14
Q

How often should the PEC be cleaned?

A
  • At the beginning of each shift
  • Before each CSP batch
  • Not longer than 30 minutes after previous cleaning when CSP preparation is ongoing
  • After spills
  • If surface contamination known/suspected
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15
Q

Low risk CSPs

A
  • must be done in ISO Class 5 air
  • Source ingredients, devices, components were sterile at baseline
  • Cannot mix more than 3 commercial sterile products (including the bag)
  • Cannot puncture more than 2 entries into any one sterile container or package (including final container)
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16
Q

Medium risk CSPs

A
  • Aseptic manipulations under low-risk conditions and 1 or more conditions exist:
    • products are combined/pooled to administer to multiple patients OR one patient on multiple occasions (batch compounding)
    • complex aseptic manipulations other than single volume transfer
    • requires unusually long duration for compounding
    • combining more than 3 commercial products or more than 2 entries into a single container
  • include Total parenteral nutrition compounding
  • include Use of automated compounding devices, elastomeric pumps
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17
Q

High risk CSPs

A
  • Preparations compounded under specific conditions are contaminated or at high risk of contamination
    • Non-sterile ingredients or devices employed prior to terminal sterilization
    • Personnel improperly garbed and gloved
    • Sterile water-containing preparations stored for more than 6 hours before sterilization
  • Any of the following are exposed to air quality worse than ISO 5 for > 1 hour
    • sterile contents of commercial products
    • CSPs that lack effective antimicrobial preservatives
    • sterile surfaces of devices and containers for preparation, transfer, sterilization and packaging of CSPs
  • Assuming and not verifying by examination of label and documentation of suppliers or direct determination
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18
Q

immediate use

A
  • must be administered within 1 hour of preparation

- must be low risk

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19
Q

immediate use, room temp BUD

A

1 hour

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20
Q

immediate use, refrigerated BUD

A

1 hour

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21
Q

immediate use, freezer BUD

A

N/A

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22
Q

low risk, room temp BUD

A

48 hours

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23
Q

low risk, refrigerated BUD

A

14 days

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24
Q

low risk, freezer BUD

A

45 days

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25
Q

medium risk, room temp BUD

A

30 hours

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26
Q

medium risk, refrigerated BUD

A

9 days

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27
Q

medium risk, freezer BUD

A

45 days

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28
Q

high risk, room temp BUD

A

24 hours

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29
Q

high risk, refrigerated BUD

A

3 days

30
Q

high risk, freezer BUD

A

45 days

31
Q

segregated compounding area BUD

A
  • 12 hours in fridge and room temp

- N/A for freezer

32
Q

Supplies within the PEC (ISO class 5 air)

A
  • Single-dose vials may be used for multiple needle entries up to 6 hours after initial needle puncture (check facility policy)
  • Opened ampules shall not be stored for any time
  • Multiple-dose containers (with preservatives) after needle puncture can have 28 day BUD unless otherwise specified by manufacturer
33
Q

What is the BUD for a multiple dose vial that has been punctured?

A

28 days

34
Q

What are things that needs to be on a patient label?

A
  • Name, ID#, room#
  • Ingredients and amount per CSP
  • Solution vehicle and volume quantity
  • Due time (for administration)
  • Date/time of preparation
  • Name/initials of pharmacist verifying CSP
  • Expiration/BUD, storage, special conditions
35
Q

What is the BUD for a single dose vial that has been punctured?

A

6 hours

36
Q

ISO 5 particles

A

≤ 100 particles/ft3 (class 100)

37
Q

ISO 7 particles

A

≤ 10,000 particles/ft3 (class 10,000)

38
Q

ISO 8 particles

A

≤ 100,000 particles/ft3 (class 100,000)

39
Q

Direction of airflow for negative pressure room

A

inward airflow to contain any airborne drug

40
Q

How often should the PEC be certified?

A

semiannually

41
Q

How often should ISO 5-8 be certified?

A

semiannually

42
Q

How often should the PEC prefilters be inspected?

A
  • inspected monthly

- cleaned or changed at least quarterly

43
Q

How often should a HEPA filter be changed?

A

repaired or replaced when recommended by a qualified certifier

44
Q

How often should temperature be documented?

A

daily

45
Q

How often should the accuracy and precision of devices such as automated compounders and repeater pumps be documented?

A

daily

46
Q

List the proper sequence of steps/method for cleaning a horizontal LAFW.

A
  • Wipe parallel to the HEPA filter
  • Clean top surface first (if a solid panel)
  • Clean IV pole (if present)
  • Clean sides (top to bottom)
  • Clean the bottom work surface last
47
Q

What product should you use to clean a horizontal LAFW?

A

Sterile 70% isopropyl alcohol

48
Q

Demonstrate and/or recognize proper procedures for hand hygiene

A
  • Remove all jewelry, watches, etc
  • Wet hands/arms up to elbows
  • Apply bactericidal soap
  • Thoroughly scrub up to elbows, > 30 seconds
    • Front/back of hands, between fingers, nails / nailbeds
    • Rinse down hands toward elbows
    • Use clean, lint free towel to dry hands/arms and turn off faucet
    • Touch only gowning supplies until gloves applied
49
Q

List and/or recognize examples of and/or the purpose of barrier controls

A
  • Gowns: Minimize shedding, personnel protection
  • Hair covers: Minimize shedding of hair/skin
  • Face masks: Physical barrier to prevent contamination from sputum particles
  • Shoe covers: Prevent tracking contamination
50
Q

When do you need to double glove?

A

during hazardous compounding

51
Q

proper procedures for garbing / gowning

A
  • Apply garbing apparel from head down
    • Face mask/beard cover
    • Hair cover
    • Shoe covers
52
Q

purpose of PEC

A
  • to produce a clean air environment

- prevents room air from entering sterile environment

53
Q

critical sites

A
  • any location at which the product may contact the environment
  • examples: septum, uncapped needles, filter straws, spikes from tubing, open ampules, bag/bottle connections, compounder connections
54
Q

critical pathways

A

any route by which the product may become exposed to contamination

55
Q

First air

A
  • flows directly from the face of the HEPA filter and is essentially sterile
  • if first air is disturbed or blocked, it’s not possible to assure sterile air will reach critical sites
56
Q

How can hood airflow is disrupted?

A
  • erratic movements near the front of the hood
  • talking into the hood
  • central heat/air ventilation systems in the room
  • rapid hand movements in the hood
57
Q

flow through the horizontal laminar flow hood

A
  • provide only product protection
  • Intake through a pre-filter in the front/below workbench to remove gross particles
  • Next the pre-filtered air moves up through the HEPA and plenum before emerging horizontally from back to front in parallel streams
  • No object should be placed between a sterile object and the HEPA filter, to avoid disruption of sterile airflow to the critical areas/sites
58
Q

flow through the vertical laminar flow hood

A
  • provide only product protection
  • Intake down through the grids in front and back, pre-filtered and HEPAfiltered before sterile air emerges from the top of the cabinet vertically down across the workbench
  • No object should be placed above a sterile object to disrupt airflow from the HEPA filter downward over the critical areas/sites
59
Q

Biological safety cabinets (BSC)

A
  • Can provide personnel protection against harmful agents
  • Can provide preparation protection
  • Can provide environmental protection from contamination by the harmful agent(s)
  • have vertical laminar airflow to limit emergence of air from the PEC
  • different types vary in their ability to protect personnel, the preparation, and the environment
60
Q

buffer area

A
  • Controls concentration of airborne particles through HEPA filtration, continuous circulation of air, and a barrier between less clean environments
  • Maintains appropriate temperature, humidity, air pressure and flow patterns
  • May also have additional features such as ultraviolet irradiation, airlock entry portals, sticky mats on floors, and positive air pressure to minimize contaminated air entry
  • The lower the classification number, the cleaner the environment
  • Must be free of materials introducing particulates such as cardboard boxes
  • Should not allow for regular traffic
61
Q

ante room

A
  • Adjacent to the buffer area or clean room

- A non-aseptic environment used for order entry, gowning and handling stock

62
Q

What are the types of contamination?

A
  • downstream contamination
  • backwash contamination
  • cross-stream contamination
63
Q

downstream contamination

A
  • occurs when a critical site is located downstream from an object blocking the flow of first air
  • Improper placement of objects within the hood creates turbulent flow
    • 3 times the diameter of an object placed in the middle of the hood
    • 6 times the diameter of an object placed against the side of the hood
64
Q

backwash contamination

A
  • room air washes back into the front of the hood
  • the first 6 inches of air inside the hood should be presumed contaminated
  • air currents from ventilation or central heat/air
  • movements of personnel around the front of the cabinet
  • personnel movements within the hood
65
Q

cross-stream contamination

A
  • disturbance in air flow currents carry contamination from one object to another in a cross-wise manner
  • objects placed too close to each other
  • rapid hand movements across objects
66
Q

Proper cleanroom behavior

A
  • Avoid talking, coughing, sneezing into the laminar airflow cabinet or direct such actions away from the sterile environment
  • Avoid excessive or erratic movements around the laminar airflow cabinet
  • Eating, drinking or chewing gum are strictly prohibited in the environment
67
Q

temperature range for refrigerated compounds

A

36‐46° F or 2‐8° C

68
Q

transient flora

A
  • comprises 15% on the skin

- can be removed with washing)

69
Q

resident flora

A
  • comprises 85% on the skin – deep in sebaceous glands

- renews the transient flora shortly following handwashing

70
Q

level of sterility of gloves

A
  • gloves provide a bacteriostatic surface that can be disinfected frequently to reduce contaminant transfer
  • do not remain sterile
  • wash gloves to remove particles
  • disinfect with sterile 70% isopropyl alcohol before use and frequently during use
71
Q

How long does a horizontal laminar flow workbench (LAFW) must be in operation prior to compounding?

A

24 hours or 30 min continuously prior to sterile compounding

OU Practice Spring 2018 (9 decks)

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