3: Sterile compounding

Question 1

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

Answer 1

institution objective

Question 2

Most direct parenteral =

Answer 2

IV

Question 3

environmental contaminants include

Answer 3

particulate matter
microorganisms
allergens
pyrogens
drug residues

Question 4

line clearance

Answer 4

sanitizing environment for drug residues

Question 5

fever causing residues of dead and decomposing microorganisms

Answer 5

pyrogens

Question 6

2 main systems of demonstrating product quality

Answer 6

quality control

quality assurance

Question 7

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

Answer 7

quality control

Question 8

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

Answer 8

proof of quality or validation

Question 9

Validation is accomplished by performing a

Answer 9

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

Question 10

is quality assurance direct or indirect

Answer 10

indirect- also known as validation

Question 11

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

Answer 11

T

Question 12

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

Answer 12

process auditing

Question 13

process auditing is part of

Answer 13

quality assurance

Question 14

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

Answer 14

F- also requires process auditing

Question 15

_______ controls: reduce contamination potential

Answer 15

Engineering

Question 16

______ controls: to reduce contamination transfer

Answer 16

Barrier

Question 17

_______ control: to reduce contamination events

Answer 17

Personnel

Question 18

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

Answer 18

enginnering controls

Question 19

primary engineering controls

Answer 19

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

Question 20

secondary engineering controls

Answer 20

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

Question 21

2 primary engineering controls in pharmacies (hood)

Answer 21

Laminar flow cleaning bed (LFCB)

Laminar flow workbench (BSC)

Question 22

what can’t you use in hoods

Answer 22

hazardous things, cytotoxic powders

Question 23

HEPA filter efficiency

Answer 23

at least 99.95%

Question 24

HEPA filter made with

Answer 24

fiberboard frame and continuous neoprene gasket

Question 25

filter medium of HEPA filter

Answer 25

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

Question 26

uninterrupted clean air issuing directly from the HEPA filter face

Answer 26

first air

Question 27

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

Answer 27

F- only supplies clean air

Question 28

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

Answer 28

critical sites

Question 29

Downstream contamination

Answer 29

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

Question 30

Backwash contamination

Answer 30

When room air is allowed to wash back into the LFCB

Question 31

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

Answer 31

zone of confusion

Question 32

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

Answer 32

6 object diameters

Question 33

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

Answer 33

cross contamination

Question 34

most common BSC in pharmacies

Answer 34

class II type A/B3

Question 35

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

Answer 35

70% | 30%

Question 36

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

Answer 36

A

Question 37

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

Answer 37

B

Question 38

air splits as it approaches work surface =

Answer 38

smoke zone

Question 39

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

Answer 39

Chemotherapeutic agent compounding

Question 40

how to degown

Answer 40

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

Question 41

T or F: always assume gown sleeves are contaminated

Answer 41

T

Question 42

most common source of contamination is

Answer 42

touch

Question 43

Transient flora:

Answer 43

15% contaminant- removed by hand washing

Question 44

what contamination is present even after hand disinfection

Answer 44

resident flora

Question 45

can you still compound if you have a cold

Answer 45

no- no URI

Question 46

how to disinfect hoods

Answer 46

water based disinfectant first | then 70% isopropyl alcohol and allow evaporation

Question 47

how to place vials in vertical flow hood

Answer 47

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

Question 48

can you hang bags in vertical flow

Answer 48

no

Question 49

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

Answer 49

¾ | 20%

Question 50

which to perform first, difficult or easy manipulations

Answer 50

difficult

Question 51

ability of operator to perform fundamental core manipulative techniques

Answer 51

technique validation

Question 52

suitability of applications of techniques to a specific compounding process

Answer 52

process validation

Question 53

assembling a needle/ syringe steps

Answer 53

Don't block flow of first air to connection site | Keep needle packaging on at handling site

Question 54

drawing liquids from vials steps

Answer 54

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

Question 55

reconstituting powders in vials steps

Answer 55

``` 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 ```

Question 56

drawing liquids from ampules

Answer 56

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

Question 57

Use of vented dispensing pins steps

Answer 57

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

Question 58

what can you use to not use the seesaw technique

Answer 58

dispensing pins

Question 59

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

Answer 59

vented dispensing pins

Question 60

Use of repeated syringes steps

Answer 60

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

Question 61

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

Answer 61

automated compounding devices

Question 62

risks with automated compounding devices

Answer 62

Any errors can affect multiple patients

Question 63

Bag with end type additive port injection

Answer 63

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

Question 64

Bag with belly port steps

Answer 64

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

Question 65

where to inject into bottle

Answer 65

triangle