3: Sterile compounding Flashcards
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
institution objective
Most direct parenteral =
IV
environmental contaminants include
particulate matter microorganisms allergens pyrogens drug residues
line clearance
sanitizing environment for drug residues
fever causing residues of dead and decomposing microorganisms
pyrogens
2 main systems of demonstrating product quality
quality control
quality assurance
_________: Release test for sterile products: pyrogen free + sterility test (requires 2 weeks of incubation- not practical in hospital setting)
quality control
system’s demonstrated ability to produce good produces that meets specifications
proof of quality or validation
Validation is accomplished by performing a
simulation of the actual process using microbiological growth media in place of the product = indirect
is quality assurance direct or indirect
indirect- also known as validation
T or F: Quality assurance also requires proof that the validated system is continuing to operate as it should
T
the product is acceptable if the process and personnel have been validated and regular monitoring detects no deterioration of operating conditions
process auditing
process auditing is part of
quality assurance
T or F: validation alone is enough to prove product acceptability
F- also requires process auditing
_______ controls: reduce contamination potential
Engineering
______ controls: to reduce contamination transfer
Barrier
_______ control: to reduce contamination events
Personnel
Used to produce work environment that is free of airborne contaminants that is easy to clean and disinfect
enginnering controls
primary engineering controls
Produce a critical work zone with sterile supply air where aseptic manipulations are done
secondary engineering controls
Used to create a buffer zone between the critical work zone and outside environment
2 primary engineering controls in pharmacies (hood)
Laminar flow cleaning bed (LFCB)
Laminar flow workbench (BSC)
what can’t you use in hoods
hazardous things, cytotoxic powders
HEPA filter efficiency
at least 99.95%
HEPA filter made with
fiberboard frame and continuous neoprene gasket
filter medium of HEPA filter
paper link material made of borosilicate glass which is pleated around aluminium separator to increase filtration area
uninterrupted clean air issuing directly from the HEPA filter face
first air
T or F: first air removes contaminants from inside the hood
F- only supplies clean air
any location or route through which the product may become directly exposed to contaminants
critical sites
Downstream contamination
When critical site is placed downstream from another object blocking the flow of first air from the HEPA filter
Backwash contamination
When room air is allowed to wash back into the LFCB
Object in LFCB creates a _______ which extends 3 object diameters downstream from object towards open end of LLC
zone of confusion
If object at side of hood, zone of confusion extends to __ as air is only flowing on one side
6 object diameters
Disturbances created in the airstream cause air currents to flow crosswise in the LMCD, carrying contamination from one object to another
cross contamination
most common BSC in pharmacies
class II type A/B3
___ of internal airflow is recirculated, __% is vented outside through exhaust HEPA filter (30% replaced by equal amount of in flowing air = makeup air)
70%
30%
Type __: no exhaust connection outside = directly into room air
Not suitable for anything that produces hazardous fumes and vapors
A
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
B
air splits as it approaches work surface =
smoke zone
what kind of compounding requires rigorous training including validation exercises to compound without transferring contaminants to general environment
Chemotherapeutic agent compounding
how to degown
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
T or F: always assume gown sleeves are contaminated
T
most common source of contamination is
touch
Transient flora:
15% contaminant- removed by hand washing
what contamination is present even after hand disinfection
resident flora
can you still compound if you have a cold
no- no URI
how to disinfect hoods
water based disinfectant first
then 70% isopropyl alcohol and allow evaporation
how to place vials in vertical flow hood
place vials in checkerboard pattern as long as hands don’t pass over them
can you hang bags in vertical flow
no
syringe should never be more than __full, but always at least ___ of syringe capacity
¾
20%
which to perform first, difficult or easy manipulations
difficult
ability of operator to perform fundamental core manipulative techniques
technique validation
suitability of applications of techniques to a specific compounding process
process validation
assembling a needle/ syringe steps
Don’t block flow of first air to connection site
Keep needle packaging on at handling site
drawing liquids from vials steps
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
reconstituting powders in vials steps
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
drawing liquids from ampules
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
Use of vented dispensing pins steps
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
what can you use to not use the seesaw technique
dispensing pins
what can reduce the risk of coring and drug release into environment
vented dispensing pins
Use of repeated syringes steps
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
___________ reduce time required to transfer large vol. of solution for complex compounding tasks
automated compounding devices
risks with automated compounding devices
Any errors can affect multiple patients
Bag with end type additive port injection
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
Bag with belly port steps
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
where to inject into bottle
triangle
