3: Sterile compounding Flashcards

1
Q

assure continuation of the quality guaranteed by the manufacturers of parenteral drugs and solutions which are compounded by the clinical, hospital, and home healthcare pharmacy

A

institution objective

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2
Q

Most direct parenteral =

A

IV

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3
Q

environmental contaminants include

A
particulate matter
microorganisms
allergens
pyrogens
drug residues
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4
Q

line clearance

A

sanitizing environment for drug residues

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5
Q

fever causing residues of dead and decomposing microorganisms

A

pyrogens

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6
Q

2 main systems of demonstrating product quality

A

quality control

quality assurance

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7
Q

_________: Release test for sterile products: pyrogen free + sterility test (requires 2 weeks of incubation- not practical in hospital setting)

A

quality control

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8
Q

system’s demonstrated ability to produce good produces that meets specifications

A

proof of quality or validation

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9
Q

Validation is accomplished by performing a

A

simulation of the actual process using microbiological growth media in place of the product = indirect

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10
Q

is quality assurance direct or indirect

A

indirect- also known as validation

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11
Q

T or F: Quality assurance also requires proof that the validated system is continuing to operate as it should

A

T

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12
Q

the product is acceptable if the process and personnel have been validated and regular monitoring detects no deterioration of operating conditions

A

process auditing

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13
Q

process auditing is part of

A

quality assurance

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14
Q

T or F: validation alone is enough to prove product acceptability

A

F- also requires process auditing

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15
Q

_______ controls: reduce contamination potential

A

Engineering

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16
Q

______ controls: to reduce contamination transfer

A

Barrier

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17
Q

_______ control: to reduce contamination events

A

Personnel

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18
Q

Used to produce work environment that is free of airborne contaminants that is easy to clean and disinfect

A

enginnering controls

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19
Q

primary engineering controls

A

Produce a critical work zone with sterile supply air where aseptic manipulations are done

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20
Q

secondary engineering controls

A

Used to create a buffer zone between the critical work zone and outside environment

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21
Q

2 primary engineering controls in pharmacies (hood)

A

Laminar flow cleaning bed (LFCB)

Laminar flow workbench (BSC)

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22
Q

what can’t you use in hoods

A

hazardous things, cytotoxic powders

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23
Q

HEPA filter efficiency

A

at least 99.95%

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24
Q

HEPA filter made with

A

fiberboard frame and continuous neoprene gasket

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25
Q

filter medium of HEPA filter

A

paper link material made of borosilicate glass which is pleated around aluminium separator to increase filtration area

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26
Q

uninterrupted clean air issuing directly from the HEPA filter face

A

first air

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27
Q

T or F: first air removes contaminants from inside the hood

A

F- only supplies clean air

28
Q

any location or route through which the product may become directly exposed to contaminants

A

critical sites

29
Q

Downstream contamination

A

When critical site is placed downstream from another object blocking the flow of first air from the HEPA filter

30
Q

Backwash contamination

A

When room air is allowed to wash back into the LFCB

31
Q

Object in LFCB creates a _______ which extends 3 object diameters downstream from object towards open end of LLC

A

zone of confusion

32
Q

If object at side of hood, zone of confusion extends to __ as air is only flowing on one side

A

6 object diameters

33
Q

Disturbances created in the airstream cause air currents to flow crosswise in the LMCD, carrying contamination from one object to another

A

cross contamination

34
Q

most common BSC in pharmacies

A

class II type A/B3

35
Q

___ of internal airflow is recirculated, __% is vented outside through exhaust HEPA filter (30% replaced by equal amount of in flowing air = makeup air)

A

70%

30%

36
Q

Type __: no exhaust connection outside = directly into room air
Not suitable for anything that produces hazardous fumes and vapors

A

A

37
Q

Type _: connected to outside exhaust by negative pressure ducts
Can be used with small amounts of hazardous vapours provided that negative pressure is maintained in the exhaust duct

A

B

38
Q

air splits as it approaches work surface =

A

smoke zone

39
Q

what kind of compounding requires rigorous training including validation exercises to compound without transferring contaminants to general environment

A

Chemotherapeutic agent compounding

40
Q

how to degown

A

Grab opposite back shoulder, and cover the sleeve portion when taking it off (surface that is contaminated put on inside), ball it up with sleeves inside for disposal

41
Q

T or F: always assume gown sleeves are contaminated

A

T

42
Q

most common source of contamination is

A

touch

43
Q

Transient flora:

A

15% contaminant- removed by hand washing

44
Q

what contamination is present even after hand disinfection

A

resident flora

45
Q

can you still compound if you have a cold

A

no- no URI

46
Q

how to disinfect hoods

A

water based disinfectant first

then 70% isopropyl alcohol and allow evaporation

47
Q

how to place vials in vertical flow hood

A

place vials in checkerboard pattern as long as hands don’t pass over them

48
Q

can you hang bags in vertical flow

A

no

49
Q

syringe should never be more than __full, but always at least ___ of syringe capacity

A

¾

20%

50
Q

which to perform first, difficult or easy manipulations

A

difficult

51
Q

ability of operator to perform fundamental core manipulative techniques

A

technique validation

52
Q

suitability of applications of techniques to a specific compounding process

A

process validation

53
Q

assembling a needle/ syringe steps

A

Don’t block flow of first air to connection site

Keep needle packaging on at handling site

54
Q

drawing liquids from vials steps

A

Inject air at least 5mL less than fluid intended to remove
Swab vial and allow alcohol to dry
V grip: Wedge vial between 2 fingers while holding syringe with thumb and ring finger to not block first air
If vertical air flow = hold sideways so that vial is slightly higher than syringe
Horizontal = can hold vertically
Never force air into vial
Low pressure or see saw technique: Pull out fo get fluid into syringe first, when there is resistance put some air into vial- seesaw manner until no air left in syringe
Done properly = no drug released into environment
Remove vial from needle

55
Q

reconstituting powders in vials steps

A
Have fluid and air in syringe 
Pull out syringe while it is in vial
Let pressure of vial pull fluid into vial itself, don’t push
Pull out by seesaw 
Take vial off needle
56
Q

drawing liquids from ampules

A

Disinfect
Use 2 hands to break at pressure points- thumb just below the neck
Dots at proper pressure points
Can use cotton pad when breaking open for safety
Point ampule towards side of hood so fragments don’t fly towards filter or person
Draw up immediately with normal needle
Don’t push needle against bottom of ampule to avoid drawing up glass fragments
Switch to filter needle to transfer contents to minibag

57
Q

Use of vented dispensing pins steps

A

Insert directly into middle of vial
Remove cap and place it inside up in first air
Push fluid into vial and reconstitute as usual
Recap
Put IV label on vial
When ready to withdraw drug, remove cap again into first air
Remove needle or cap from syringe
Invert
Withdraw- no seesaw needed
Unlock horizontally, tipping both so that the syringe and vial are both pointing upwards as they separate
Put on syringe
Replace dispensing pin cap
Never remove and replace pin - never reuse, even if it’s the same vial

58
Q

what can you use to not use the seesaw technique

A

dispensing pins

59
Q

what can reduce the risk of coring and drug release into environment

A

vented dispensing pins

60
Q

Use of repeated syringes steps

A

Place bag and port or bottle in first air, remove plastic cover
Remove cap from spike end of tubing
Insert into administration port, puncturing the inner seal
Hang the bag or bottle
Prime = press plumber completely, repeat until the tubing and syringe are filled
Adjust syringe to desired volume by depressing the plunger and turning the retaining nut down the threaded shaft to lock the plunger in place
Always replace needles prior to use
Deliver into vial = single plunge, otherwise can draw up fluid = changes final vol. delivered
Label reconstituted vial

61
Q

___________ reduce time required to transfer large vol. of solution for complex compounding tasks

A

automated compounding devices

62
Q

risks with automated compounding devices

A

Any errors can affect multiple patients

63
Q

Bag with end type additive port injection

A

Sanitize bag port and remove cap
Push needle straight into middle of port
Make sure needle is long enough to pass through tube into the bag
No more than 4 units (bags) laid out at the same time

64
Q

Bag with belly port steps

A

Sanitize before loading into hood
Must be laying to maximize first air, as hanging doesn’t see port getting first air
Press on lower part of bag to push belly port area up- prevent needle from contacting rear side of bag
Mix thoroughly

65
Q

where to inject into bottle

A

triangle