PHM 652: Exam 2 (Parenteral Products) Flashcards
(144 cards)
Define Parenteral
administered by any way other than through the mouth; applied, for ex. , to the introduction of drugs or other agents into the body BY INJECTION
all parenteral products and ophthalmic dosage forms must be what
STERILE
define aseptic technique
ability of personnel to manipulate sterile preparations, sterile packaging components, and sterile administration devices in a way that excludes the introduction of viable microorganisms
ex. of parenteral routes
- IV
a. injection to venous (not arterial) system
I.perioheral
II. central - Intraarterial (uncommon)
- Intramuscular (IM)
- Intrathecal (IT)
a. injection into meninges of spinal cord) - Epidural
a. injection to tissues surrounding spinal cord, not spinal cord itself - Intradermal (ID)
a. injection within the skin - SubQ
a. injection beneath the skin
what does it mean to be sterile
freedom from all living organisms
an absolute. no such thing as almost sterile
medical devices used along with parenteral administration must be what
ex of these medical devices
STERILEEE
includes things like
needles syringes tubing bags etc
health status when compounding sterile products
need to be free from infectious disease
personal preparation
cover head and facial hair
remove cosmetics likely to flake
remove finger and wrist jewelry
how to wash hands
scrub hands and arms to elbows
pre wash
use 3-5ml for 30 seconds
wash hands even if gloves are to be worn
gloves
types:
composition
when should you change your gloves?
a.sterile vs non sterile
powdered vs non powdered
b.composition:
latex
vinyl
synthetic
c. depend on pharmacy but usually ~1 hr
better products for hand washing than plain soap in high risk situations
alcohols chlorhexidane gluconate iodophors hexaclorophene parachlorometaxylenol triclosan
gowns
composition
a. tyvek: non permeable substance
other coverings when preparing iv
shoe covers and sticky mats
masks: put on right b4 going in hood and changeeverytime leaving compounding area
note: surgical masks only protect product that you’re making, not you
what is the last step before entering iv room
WASH HANDS
Laminar air flow SYSTEM
types
how long should it be turned on for before using
Horizontal flow hoods (LAFS)(laminar air flow system): filtered air directed toward pharmacist/ tech located at back of hood
vertical flow hood (BSC)(Biological safety cabinets)
filtered air directed downward from a pen located at the top of hood. used for chemo. more preotection
at least 15 min. but UB SPPS policy is 30 min
HEPA
HIGH EFFICIENCY PARTICULATE AIR Filter
removes 99.9% of all particles 0.3 microns (um) or larger
disadvantage of laminar air flow
false sense of security
ISO classifications of particulate matter in room air
requires air quality in IV rooms iso class 5 or better (room mustn’t contain more than 3520 particles that are >/= 0.5 um in size)
(class 5: a.US class 100 b. Particle size I. ISO m3: 3520 FS 209E, ft3
besicaly the smaller the number, the better the air quality
pyrogens
metabolic products of living organisms, or dead microorganisms
lipopolysaccharides: soluble in water but insoluble in organic solvents
aseptic technique ideally prevents the intro to parenteral products
pharm effects of pyrogens
- vary
- in man, pyrogenic causes fever and chills
- after injection, rapid raise in body temp, chills and headache, malaise after 45-90 min latent period
- anaphylaxis
source of pyrogens in sterile compounding
- water (solvent)
- containers (packaging)
- chemicals (used for solution preparation)
how to eliminate pyrogens
- dry heat (for metal and glass ocntainers
- chemically : for solutions but can destroy durgs
- synthetic filter media:
- best approach . PREVENT THEM FROM OCCURING
unecessary factors that can cause microorganism intro to product in i room
talking
laughing
chewing gum
eat/drink
CSP (compounded sterile product) risk levels
definition:
assigned according to relative possibility that a compounded sterile product might be contaminated
LOW
MEDIUM
HIGH