Term
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Definition
ethylene oxide
ionising radiation |
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Term
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Definition
simplest cyclic ether
colourless gas at RT
liquid at 12 degrees
water and organic solvent dissolve in it
>3% in air flammable
explosive when mixed with air at increased conc |
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Term
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Definition
toxic to operator and bioburden
Contact: skin eruptions, oedema, erythems
vapour: eye and nose irritation, N, dizzy |
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Term
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Definition
alkylates SH, amines, COOH, OH
wide spectrum: vegetative bacteria, Lge viruses, spores more resistant |
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Term
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Definition
thermolabile equipmentL pastics
lensed equipment
rubber
electrical
Medicaments: thermolabile solids (outside only) only as a last resort |
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Term
| EO and BP recommendations |
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Definition
only as last resort
must be penetrated by gas and moisture to be sterile and gas elimination must be below toxic levels |
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Term
EO factors influencing efficiency.
1st order kinetics |
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Definition
conc usually 500-800mg/l
temp: rate of inactivation doubled by every 10 degrees
humidity: EO ineffective against dehydrated microbes in a dry environment so water acts as a carrier of EO thru permeable barriers, optimum humidity 33%
EO needs monitoring of these parameters |
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Term
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Definition
use a biological indicator for validation of cycle and for routine operations
Chemical indicators
need a suitable sample of each batch tested for sterility before batch is released |
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Term
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Definition
| sterilisation vis gamma and x-rays or accelerated electrons |
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Term
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Definition
kills all types of microbes
penetrate solids and liquids
don't heat or wet materials much |
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Term
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Definition
plastic syringes and catheters
hypodermic needles and scalpel blade
adhesive dressing
polythene containers
pharmaceutical and biological properties
single application capsules or eye ointments and catgut
aluminium foils and plastic film packaging |
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Term
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Definition
3 stages: ionisation
radical formation
biochemical changes
2 types of DNA damage: breaks 1 or both DNA strands
lesions in the nitrogenous bases |
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Term
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Definition
gray (Gy): 1 joule abs per kilo of material irradiated.
terminal sterilisation is 25kGy
may use other doses, but must give SAL of 10 to the power of negative 6 |
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Term
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Definition
sensitive: vegetative bacteria 0.5-10kGy
moderately: moulds and yeasts 4-30kGy
resistant: bacterial spores (10-50) viruses (1--40)
highly resistant: bacillus spores (35-80) |
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Term
| factors affecting IR susceptibility |
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Definition
oxygen: increases resistance
moisture: related to oxygen
temp: reduce D value
organic substances: protective effect
chemical agents: free radical scavenger |
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Term
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Definition
monitor radiation abs using dosimeters
use suitable biological indicator |
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Term
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Definition
| the chosen sterilisation procedure is investigated to ensure effectiveness and integrity of the product and procedure before applied in practice |
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Term
| good manufacture practise should include: |
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Definition
qualified people and training
adequate premises
suitable equipment
adequate precautions
validated procedures for critical steps
environmental monitoring and in process testing |
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Term
| performance qualification data |
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Definition
evidence that equipment will produce sterile product
physical performance: specified conditions have been met
biological performance: conditions delivery required microbe lethality |
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Term
| validation of a sterilisation process: |
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Definition
don't test the products
tests the process
process is in control=sterile
if one or more variables is out of limits process may fail |
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Term
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Definition
physical, chemical or biological
depend on process |
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Term
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Definition
| for temp and time exposure |
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Term
| types of physical indicators: |
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Definition
hot air oven: temp and time by temp record sheet.
autoclave: uses thermocouple and a printed out record plus F0 integrated result sheet |
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Term
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Definition
vary depend on method, but generally change in physical or chemical nature
these indicate if they have gone thru a process but not sterility. eg autoclave tape |
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Term
| chemical indicator types: |
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Definition
dry heat indicator: time and heat placed in pack (tan to black)
exposure tape: sealing tape so no need to open pack
moist heat: thermalog S: steam time and temp (chemical melts to either safe or unsafe regions)
EO thermalog G: measure (EO) safe or unsafe
bowie-dick: (air removal) autoclave with pre-vacuum (1st cycle of the day)
Brownes tube: change colour, 2 types for 120/20mins or 160/60mins |
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Term
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Definition
standardised preparations of selected microbes to assess effectiveness of sterilisation
usually the most resistant eg spores |
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Term
| biological indicator types: |
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Definition
spore strips on filter paper
contaminated gauze or syringes
after exposure remove asceptically and incubate in suitable media
no growth sterilisation process has sufficient lethality |
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Term
| aseptic compounding process |
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Definition
| media-fill runs can be used to evaluate the process of aseptic production. sterility test is the only other available method and the main method. |
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Term
| sterility test via product: |
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Definition
rely on statistical probability (not a powerful test)
destructive test: relies on probability that every container is the same
Pass or fail: do not tell you where went wrong |
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Term
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Definition
for filtration sterilisation method
bubble point test: before and after sterilisation (is the minimal pressure required to force liquid out of the pores is a measure of the largest pore diameter) |
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Term
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Definition
terminally sterilised products
when fully validated terminal sterilisation method by stream, dry heat or IR is used
parametric release is the release of batch of sterilised items based on process data rather than on the basis of submitting a sample of items to sterility testing.
needs approval from authority
needs validated sterilising conditions |
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