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Pharm Practice 4 > Compounded Sterile Products > Flashcards

Compounded Sterile Products Flashcards

1
Q

Minimum acceptable ISO air class for an ante area

A

ISO 8

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2
Q

Acceptable ante area activities

A

hand hygiene/garbing
staging of compounding materials
order entry/CSP labeling

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3
Q

Purpose of pressure relationships established by an ante area

A

Maintains pressure relationships to adjacent rooms

Air flows out: from clean to “dirty”

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4
Q

Minimum acceptable ISO air class for a buffer area and characteristics

A

ISO 7
Components and supplies for compounding
Location of the primary engineering control/hood

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5
Q

Physical location of a primary engineering control in relation to an ante area and buffer are

A

In ISO 7 air buffer area, away from doors, air vents, general traffic areas

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6
Q

Minimum acceptable ISO air class for a clean room

A

ISO 5 - same as the primary engineering control

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7
Q

Direction of airflow in a negative pressure room

A

Keeps contaminated air in.

Ante area is negative compared to the buffer area but still more positive than outside air.

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8
Q

Direction of airflow in a positive pressure room

A

Air flows outward
Clean air flows outward toward dirty air.
Direction of air flow: clean room > buffer > ante > outside

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9
Q

Minimum acceptable ISO class for primary engineering controls

A

ISO 5

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10
Q

Examples of devices/physical spaces that serve as primary engineering controls

A

Clean room or segregated compounding area

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11
Q

Features of Segregated compounding area

A

designated demarcated space/room w/ PEC that produces ISO 5 air.
Only includes activities/materials specific to CSP prep
Only low-risk CSPs w/ BUD < 12hrs

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12
Q

Max allowed particle count per cubic foot for ISO 5, ISO 7 and ISO 8

A

ISO 5: <100 particles
ISO 7: <10,000 particles
ISO 8: <100,000 particles

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13
Q

Frequency of inspection and certification of ISO 5 environments

A

Every 6 months and if relocated or if damage to the HEPA filter

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14
Q

Compounding Hazardous materials

A

Use special procedures to prevent cross contamination and proper disposal
Dedication of equipment/hoods for hazardous compounding

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15
Q

Medium-risk compounding

A

Low risk conditions and products are combined/pooled to administer multiple patients or one pt on multiple occasions (batch compounding)
Complex aseptic manipulations other than single volume transfer
ex: TPNs, use of automated compounding devices, elastomeric pumps
Requires unusually long duration for compounding
Combined more than 3 commercial products or more than 2 entries into a single container

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16
Q

High-risk compounding

A

Compounding under specific conditions or at high risk of contamination:
Non-sterile ingredients/devices employed before terminal sterilization
Personnel improperly garbed and gloved
Sterile contents of commercial products, CSPs that lack effective antimicrobial preservatives or sterile surfaces of devices and containers for prep, transfer, sterilization and packaging that were exposed to air worse than ISO 5 for >1 hr
Assuming and not verifying that chemical purity and content strength meet original specifications

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17
Q

Compounding Hazardous materials

A

Use special procedures to prevent cross contamination and proper disposal
Dedication of equipment/hoods for hazardous compounding

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18
Q

Immediate Use

A

Emergency or immediate patient administration needed
Simple transfer <3 non-hazardous commercial products (<2 entries into 1 container)
Give w/in 1 hr of prep
Labeled/initiated by preparer w/ exact 1hr BUD

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19
Q

Beyond Use Date (BUD)

A

the shorter of the chemical stability or microbial limits of sterility by USP 797 standards

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20
Q

Time limit of use for multiple needle entries into a single-dose vial exposed to ISO 5 or cleaner air

A

Preservative free: up to 6 hrs after initial puncture

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21
Q

Time limit of use for an opened single dose ampule exposed to ISO 5 or cleaner air

A

Shall not be stored

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22
Q

BUD after initial entry of a multi-dose container

A

With preservative: 28 days after needle puncture

23
Q

Info to include on final product label

A

Name, ID#, room#, ingredients and amount per CSP, solution vehicle and volume, time due for admin, date/time of preparation, name/initials of pharmacists verifying, expiration/BUD, storage, special conditions

24
Q

Immediate Use

A

Emergency or immediate patient administration needed
Simple transfer <3 non-hazardous commercial products (<2 entries into 1 container)
Give w/in 1 hr of prep
Labeled/initiated by preparer w/ exact 1 hr BUD

25
Q

Low risk compounded in a segregated compounding area w/ ISO 5 hood BUD

A

Room temp: 12 hrs

Refrigerator: 12 hrs

26
Q

High risk BUD

A

Room temp: 24 hr
Refrigerated: 3 days
Freezer: 45 days

27
Q

Purpose of primary engineering controls

A

to produce clean air environment

28
Q

Critical sites and critical pathways

A

Sites: where ever the product may contact the environment
Pathways: any route by which the product may become exposed to contamination

ex: septum, uncapped needles, filter straws, spike from tubing, open ampules, bag/bottle connections, compounder connections

29
Q

Features of laminar airflow that prevent airborne contaminants from entering the hood

A

HEPA filter removes 99.9% particulate matter at least 50 microns in diameter

30
Q

Features of horizontal airflow hoods and methods to prevent disruption of sterile air to critical sites

A

Only product protection

Pre-filter > HEPA filter > sterile air from the back of the cabinet

Nothing should be placed between a sterile object and the HEPA filter

31
Q

Features of vertical airflow hoods and methods to prevent disruption of sterile air to critical sites

A

Only product protection

Pre-filter > HEPA filter > sterile air from the top of the cabinet

Nothing should be placed between a sterile object and the HEPA filter

32
Q

Type of protection possible w/ horizontal and vertical LAFW

A

product protection

33
Q

Type of protection possible w/ biological safety cabinet

A

Provides personnel protection against harmful agents, preparation protection, and environmental protection from contamination by the harmful agent

34
Q

Purpose of secondary engineering controls: Buffer area

A

Controls conc. of airborne particles through HEPA filtration, continuous circulation of air and a barrier between less clean environments
Maintains appropriate temp, humidity, air pressure and flow patterns

35
Q

Purpose of secondary engineering controls: ante room

A

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

36
Q

3 principle contamination models that can occur in LAFW

A

Down stream
Backwash
Cross stream

37
Q

Causes of downstream contamination

A

when critical site located downstream from an object blocking the flow of first air

38
Q

Length of turbulent flow downstream from an object placed in the middle or at the side of the horizontal LAFW

A

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

39
Q

Causes of backwash contamination

A

Room air washes back into the front of the hood
The first 6 inches of air inside the hood should be considered contaminated.
ex: air currents from ventilation/central heat/air, movement of personnel in front of the hood and in the hood

40
Q

Causes of cross-stream contamination

A

disturbance in airflow 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

41
Q

Proper clean room behavior and actions to avoid

A

avoid talking, coughing, sneezing into hood (direct actions away from the hood)
avoid excess/erratic movements
eating, drinking, chewing gum

42
Q

Quality control procedures required by Oklahoma Pharmacy Law

A
  • Daily temp documentation where CSPs are stored/compounded

- daily documentation of accuracy and precision on devices

43
Q

Proper temperature ranges required for storing refrigerated compounds

A

36-46F (2-8C)

44
Q

Quality assurance required by Oklahoma Pharmacy Law

A
  • Routine disinfection
  • Visual confirmation of garbing/gowning
  • Review CSP against orders ensuring correct identity and quality of ingredients
  • Visual inspection for particulates, leaks and accuracy/thoroughness of labeling
  • Clean rooms meet specified standards
  • Compounding area is separate/distinct from non-sterile
  • PEC used for all sterile compounding
  • Semi-annual certification of PECs, all ISO5-8 environments, segregated compounding areas
  • PEC filters inspected monthly, cleaned/changed quarterly and documented
  • PEC HEPA filter repaired/replaced according to mfg
  • initial and annual competencies
45
Q

Initial and annual competencies:

A 
Written test
Hand hygiene and garbing
Gloved fingertip sampling
Aseptic manipulation, aseptic media-fill test
Cleaning and disinfecting
Surface sampling
Equipment
Routine visual inspection of CSPs
Provision of education for immediate use
46
Q

Quality control procedures required by Oklahoma Pharmacy Law

A
  • Daily temp documented where CSPs are stored/compounded
  • daily documentation of accuracy and precision on devices
  • Recording keeping: PEC maintenance/certification, cert stamp on hood
  • Storage for prep/dispensing CSPs
47
Q

Proper temperature ranges required for storing refrigerated compounds

A

36-46F (2-8C)

48
Q

Barrier controls

A 
Gowns
Hair covers
Face masks
Shoe covers
Gloves
49
Q

Purpose of gowns

A

minimize contaminant shedding and provide personnel protection

50
Q

Purpose of hair covers

A

minimize hair/skin shedding

51
Q

Purpose of face masks

A

physical barrier to prevent sputum contamination

52
Q

Purpose of shoe covers

A

prevents tracking contaminants in and out

53
Q

Purpose of gloves

A

barrier to limit transfer of contaminants to and from hands

Pharm Practice 4 (8 decks)

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