sterile products pt 1

usp 800

usp 800

hazardous drugs

usp 795

nonsterile

usp 797

sterile preparations

usp 788

particulate matter in injections

Usp 71

sterility tests

sterile

free of microorganisms

bactericide

kills bacteria

bacteriostatic

prevents growth

antiseptic

prevents growth without destroying cells

disinfection

destroys microbes not spores

pyrogens

fever producing products

IV disadvangate

most dangerous route, rapid side effects, risk of embolus and thrombus, need skilled application

IV adv

immediate effect and large molecules can be used

IV bolus

instantaneous absorption

IV infusion

1L admin over time via pump = zero order

Intrathecal IT

into subarachnoid space of spinal cord

intraarticular def and ex

into joint space, inj glucocorticoids with joint inflammation

IV F

1

intermittent IV volume

multiple 50-100ml given in multiple doses

Constant infusion IV

single dose given continuously

IV push

small single dose given over short time

IM F

[0, 1]

IM advantages

admin easier than IV, larger volume faster absorption than SQ, larger surface area for inj, can be prolonged release (AP)

IM disadvantages

painful, less rapid onset IV, rate of blood flow depends on location

IM volume

2-5mL

SQ F

[0,1]

SQ advantages

easiest admin

SQ disadvantage

limited volume, rate dependent on Q, tissue degregation from overuse,

intra arterial ex

plasminogen for ischemic stroke

physiological factors affecting diffusion

blood flow muscle exercise depth of inj

adv for parenteral

avoid gi upset and suitable for long acting deliv (IM and SC)

disadvantage for parenteral

inconvenient drug cannot be removed more costly

t/f sterile products are pyrogen free

false

what is the most potent pyrogen

endotoxin

ex of bacterial endotoxin

lipopolysaccharide on gram negative

when do multiple dose vials expire

28 days after opening

SVP

<100ml can have preservatives, buffers, solubilizers, antioxidents or exipents

LVP

>100mL admin by IV no additive agents

LVP implication and use

fluid replacement electrolyte balance total nutrition

particulate matter

nonviable contaminants

microbial matter

viable contaminant: endotoxin, aluminum

risk of particulates in parenteral

can cause embolization

t/f particulates can be completely eliminated

f but must be controlled