Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Acceptable ante area activities

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Minimum acceptable ISO air class for a clean room

A

ISO 5 - same as the primary engineering control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Minimum acceptable ISO class for primary engineering controls

A

ISO 5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

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

A

Clean room or segregated compounding area

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Compounding Hazardous materials

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Compounding Hazardous materials

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Beyond Use Date (BUD)

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

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

A

Shall not be stored

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
Low risk compounded in a segregated compounding area w/ ISO 5 hood BUD
Room temp: 12 hrs | Refrigerator: 12 hrs
26
High risk BUD
Room temp: 24 hr Refrigerated: 3 days Freezer: 45 days
27
Purpose of primary engineering controls
to produce clean air environment
28
Critical sites and critical pathways
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
Features of laminar airflow that prevent airborne contaminants from entering the hood
HEPA filter removes 99.9% particulate matter at least 50 microns in diameter
30
Features of horizontal airflow hoods and methods to prevent disruption of sterile air to critical sites
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
Features of vertical airflow hoods and methods to prevent disruption of sterile air to critical sites
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
Type of protection possible w/ horizontal and vertical LAFW
product protection
33
Type of protection possible w/ biological safety cabinet
Provides personnel protection against harmful agents, preparation protection, and environmental protection from contamination by the harmful agent
34
Purpose of secondary engineering controls: Buffer area
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
Purpose of secondary engineering controls: ante room
non-aseptic environment used for order entry, gowning and handling stock
36
3 principle contamination models that can occur in LAFW
Down stream Backwash Cross stream
37
Causes of downstream contamination
when critical site located downstream from an object blocking the flow of first air
38
Length of turbulent flow downstream from an object placed in the middle or at the side of the horizontal LAFW
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
Causes of backwash contamination
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
Causes of cross-stream contamination
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
Proper clean room behavior and actions to avoid
avoid talking, coughing, sneezing into hood (direct actions away from the hood) avoid excess/erratic movements eating, drinking, chewing gum
42
Quality control procedures required by Oklahoma Pharmacy Law
- Daily temp documentation where CSPs are stored/compounded | - daily documentation of accuracy and precision on devices
43
Proper temperature ranges required for storing refrigerated compounds
36-46*F (2-8*C)
44
Quality assurance required by Oklahoma Pharmacy Law
- 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
Initial and annual competencies:
``` 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
Quality control procedures required by Oklahoma Pharmacy Law
- 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
Proper temperature ranges required for storing refrigerated compounds
36-46*F (2-8*C)
48
Barrier controls
``` Gowns Hair covers Face masks Shoe covers Gloves ```
49
Purpose of gowns
minimize contaminant shedding and provide personnel protection
50
Purpose of hair covers
minimize hair/skin shedding
51
Purpose of face masks
physical barrier to prevent sputum contamination
52
Purpose of shoe covers
prevents tracking contaminants in and out
53
Purpose of gloves
barrier to limit transfer of contaminants to and from hands

Pharm Practice 4 (8 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions