Term
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Definition
injection for intravenous use in containers >100ml
LVP are large volume parentals |
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Term
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Definition
| sterile solutions of simple chemicals like sugars electrolytes or amino acids, they are easily carried by the circulation |
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Term
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Definition
NaCl: ringers solution
Compound sodium lactate: hartmanns solution |
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Term
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Definition
correct electrolytes
fluid replacement
basic nutrition
vehicle for drug |
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Term
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Definition
| 1 or more sterile products to an IV fluid resulting in a combo |
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Term
| SOP (standard operating procedure) for IV admix |
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Definition
review request
plan procedure carefully
assemble materials
label
preparation
inspect
label
check
log book entry |
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Term
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Definition
manufacturing & practice level
microbial & pyrogen contamination
particulate & chemical contamination |
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Term
| stability & compatibility |
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Definition
instability: chemical reaction irreversible result in degradation and may be toxic
photostability
packaging
visual (precipitation, colour change)
nonvisual (detect via chemical analysis) |
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Term
| Kings guide to compatibility |
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Definition
X: incompatible
C: compatible
Ø: reports for both
#,*: comments
Blank: don't know |
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Term
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Definition
dose
conc.: peripheral vs central infusion
calculation check
air: embolism
mix ups between insulin and herapin have occurred |
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Term
| risk levels to compounded sterile products (CSP) |
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Definition
immediate use CSP
low risk level
low risk level with 12hrs or less BUD
medium
high |
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Term
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Definition
exempt from all requirements
only a simple aseptic transfer
no more than 3 sterile non-hazardous drugs
no delays
no contact contamination of ingredients or critical sites
admin within 1 hr
label states 1 hr and no storing or recycling |
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Term
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Definition
aseptic manipulations with ISO 5 air using sterile ingredients, products
involves only transfer, measuring and mixing
aseptically opening ampoules, syringes, needles
QA: routine disinfection
visual conformation
review all products
visual inspection of products |
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Term
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Definition
almost the same as low risk level
ISO 5 device in an uncontrolled environment
admin must begin within 12 hours
no hazardous drugs |
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Term
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Definition
same as low but the addition of 1 or more:
multiple individual or sml dose of sterile products that will be admin to multiple patients
complex aseptic manipulations
long duration eg, homogenous mixing
eg. TNP using manual or automated devices
transfer of vol from multiple ampoules or vials into a single final sterile product |
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Term
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Definition
non sterile ingredients or device
exposed to worse than ISO 5 more than 1 hr
personnel are improperly gloved and garbed
nonsterile water more than 6 hrs before sterilising
assumptions on chemical purity
eg. measuring or mixing of sterile ingredients in nonsterile devices before sterilisation is performed |
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Term
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Definition
room temp: 25 L:48hr M : 30hr H: 24hr
refrigerator: 2-8 L:14d M:9d H:3d
freezer: <-10 all at 45 days |
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Term
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Definition
visual exam
label check
compounding check
High risk vascular or CNS injection >25, multiple dose container need sterility and endotoxin test |
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Term
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Definition
particle monitoring every 6 months for ISO 5 and 7
bacteria counting |
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Term
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Definition
| to reveal the presence or absence of viable microbes in a sample number of containers taken from a batch |
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Term
| info from sterility testing |
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Definition
only show organisms capable of growing in the test media under selected condition
not used of as a sole means |
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Term
2 methods of testing for
aerobes
anaerobes
fungi |
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Definition
membrane filtration
direct inoculaion |
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Term
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Definition
aqueous preparation
pore size <0.45um
use hydrophobic edge membranes |
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Term
| membrane filtration method (MFM) |
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Definition
filtration system and membrane are 1st sterilised
under aseptic conditions
after filtration:
transfer filter to culture medium and incubate for 14 days |
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Term
| Direct inoculation method (DIM) |
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Definition
preparation directly in the culture medium, no more than 10% of the volume of the medium
incubate for 14 days and observe |
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Term
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Definition
sample size and volume
culture medium (FTM/SCDM)
incubation temp |
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Term
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Definition
<100 containers: 10% or 4 containers which ever is greater
100-500: 10 containers
>500: 2% or 20 whichever is less |
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Term
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Definition
<1ml: the whole contents of each container
1-40ml: half the contents of each container but not less than 1ml
40-100: 20ml
>100: 10% of contents, not less than 20ml
Antibiotic liquids: 1ml |
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Term
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Definition
culture for: Anaerobic (C sporogenes)
aerobic (s aureus or P aeruginsoa)
Temp:32.5 |
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Term
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Definition
culture for: fungi (C albicans)
Aerobes: (s aurues)
TEMP: 22.5 |
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Term
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Definition
require no sample
can be done parallel
eliminate false positive |
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Term
| Validation test and growth promotion test (positive control) |
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Definition
positive control
FTM: add anaerobe and aerobe
SCDM: add fungi
to confirm no growth inhibitory effect from the conditions |
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Term
| If growth in products and not negative |
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Definition
| this shows contamination from the operator is most likely |
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Term
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Definition
no growth: the product complies with the test for sterility
Growth: does not comply and fail |
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Term
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Definition
test procedure reveals a fault
microbial growth in negative control
data of the microbe monitoring of the sterility testing facility show a fault |
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Term
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Definition
| repeat test with same amount as last test |
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Term
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Definition
| for thermolabile medicaments |
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Term
| Sterilisation via filtration |
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Definition
process and environment must minimise microbial contamination
equipment, containers and closures wherever possible are subject to sterilisation process
filtration process carried out as close as possible to the filling point |
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Term
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Definition
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Term
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Definition
cold, wet
not as reliable
not terminal sterilised
thermoliable must be stable
aseptic process and multi-step |
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Term
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Definition
| provide a lge SA for filtration |
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Term
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Definition
serial filtration
finer
may stack for finer pore size |
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Term
| Depth filter and screen filter |
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Definition
depth is staggard pores
screen is straight pores |
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Term
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Definition
retention depends on nominal pore rating and selective adsorption of bacteria
pores are larger than particles removed but channels are uneven diameter and change direction in filter bed
pore diameter and retention efficiency determine the size of particle retained |
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Term
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Definition
can use vacuum or +ve pressure
pressure uniform not exceed 35-70kPa
high dirt holding capacity |
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Term
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Definition
liquid lost by retention
proteins from liquid may be adsorbed
filter fibres may shed
extractables may pass thru
penetration of microbes depends on the time required for filtration and some may pass thru especially if pressure differentials increase. |
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