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how does autoclave work?
exposure to dry saturated steam(water vapour) under pressure
what temperature and time is an autoclave usually done for?
121 degrees for 15 mins
how does steam in an autoclave kill microorganisms?
through hydrolysis of proteins like enzymes or nucleic acid
why is autoclave a terminal process?
steam touches the surfaces and heat passes through the product through heat conduction which sterilises the middle of the product too
what is terminal sterilisation?
a sealed bottle in its final packaging is sterile when removed and does not require further sterilization e.g. air filter.
why should there be no air present in an autoclave?
it will lower the amount of steam present which will lower the temperature and pressure, based on daltons law
are porous loads( pippettes)terminally sterlised in an autoclave?
no as air must be reintroduced through a bacteria proof filter
what are some advantages of autcoclaving?
terminal sterilization, kills bacteria and viruses, wide safety margin, cheap?
what are some disadvantages of autoclaving?
only thermostable products can be autoclaved,not suitable to oily preparations like cream and ointmenst
how does an hot air oven work to sterilise
does not contain water so used convection and radiation through high temperatures for longer periods of time
what is mechanism of cell death from dry heat?
oxidative process against proteins and nucleic acids
give an example of product sterilized by autoclave?
products given through the IV route- injectables
what are examples of products that can be sterilised through dry heat?
oily injectables, powders, glassware, metal equiptment prone to rusting
what are some advanatges of dry heat sterilisation?
used for substances that may be harmed by water,less damaging to glass and metal, can be used for assembled apparatus
what are the disadvantages of hot air ovens?
not suitable for packaging material like plastic/rubber, surgical dressing. not a terminal process as things need to be repackaged.
what is the mechanism of cell killing for ethylene oxide?
alkylation which disrupts the chemical function of the proteins and nucleic acids
what products would be sterilized using ethylene oxide?
single use medical devices like catheters, pacemakers wires
what are the advantages of using ethylene oxide?
use of low temperatures damages fewer materials, good penetration into porous loads and plastics, effective against all microorganisms
what are the disadvantages of ethylene oxide
there must be no residue of ethylene oxide as it is toxic,not a terminal process and requires repacking, slow and lengthy process,more expensive, gas is flammable so needs to be in a mixture
what is the source of radiation in sterilisation?
cobalt 60
what is the mechanisms of killing from using radiation as sterilisation?
production of radical which damage DNA
what are the advantages of radiation?
terminal process, very efficient, effective against many microoganism, can be used for thermo unstable products
what are some disadvantages of radiation
not effective against some viruses and prions, expensive, dangerous and perceived side effects
what is UV used to sterilise?
water
what is the smallest size a filtrate can filter out?
0.22 micro meters
what type of filter is most commonly used?
screen filter
what are the advatnages of filtration?
good for thermolabile products,moves bacterial bodies including endotoxins and LPS
what are the disadvantages of filtration
not suitable for suspension, not a terminal process, requires a sterility test, viruses and mycoplasms not removed
what is an example of a product that sterilsied using radaition?
insulin
what function groups have strong smells that can indicate product spoilage
hydrogen sulfides, amine, fatty acids
what are some examples of API that can degrade?
alkaloids like atropine, morphine, penicillin, hydrocortisone
what excipients in a formulation can microbes break down to get energy?
suspending agents, thickening agents, surfactants
what preservative can be degraded by psuedomonas
phenol
how can we alter the water content of a formulation to reduce microbial growth?
exploiting the osmotic pressure by adding alot of solutes like sugar to reduce the water activity
what water activity allows good microbial growth?
0.98
what pH range do bacteria thrive?
4-8
how does surface tension effect microbial growth?
low surface tension encourages the growth of gram negative bacteria