Sterilisation Flashcards
Spores are not killed using steam sterilisation but only through filtration
T/F?
false: Spores are not killed by filtration
1) filtration removes micro-organisms
2) spores requires temperature greater than 100 degree Celsius .
Top-to-bottom gowing up in the cleanroom is the only way in wearing the protective clothing
False, three types- top-bottom, bottom-top, inside-out
What are the main methods of sterilisation?
steam sterilisation
dry heat
filtration
You can always choose a rubber closure regardless of the active substance, vehicle and pH of the product
T/F?
False:
Rubber closure need to be compatible with the active substance, vehicle and pH of product - Go back to lecture 1
In the case of a injection controlled by Misuse of Drugs Act 1973, the label should state the total amount
T/F?
False:
Total VOLUME should be stated - Go back to first lecture and check the labelling requirements.
Viruses are only killed using filtration sterilisation?
T/F?
False;
Viruses cannot be killed by filtration:
1) filtration removes microorganisms but
2) the size of the pore 0.22um is bigger so viruses can pass through filters as they are small.
Viruses are killed using heat sterilisation techniques - Go back to final lecture about filtration.
The D value of an organism exposed to a temperature 121°C for 20 min is 5 min. What is the inactivation factor and calculate it?
Waiting for grade IF= 10^t/D = 10^20/5 = 10,000 ??
European cleanroom specification are more stringent (strict) than the US ones?
T/F?
True
because they look at in rest and in operation as well as 5 and 0.5 microns ( go over your second lecture of sterile products)
A constant number of organisms is killed during a sterilisation process
T/F?
False:
A constant proportion , not a constant number of organisms is killed per unit time
Moist heat sterilisation is unsuitable for oils and powders
T/F?
True
The preparation and sterilisation of a product must happen in the same area in the cleanroom
T/F?
False:
Should be separate from other manufacturing areas
Different types of operation must be effectively separated on from another
o Component preparation
o Solution preparation
o Filling
o Sterilisation
Filtration is a terminal sterilisation process
T/f?
False:
filtration is a non-terminal sterilisation method
Latent heat is heat required to raise the temperature of water to its boiling point ?
True/False?
False:
that is sensible heat.
Latent heat is additional heat absorbed when boiling water is converted into steam
Inside the cleanroom, the air supply should be at a positive pressure and of a suitable quality
T/F?
True
High pressure inside the clean room
Single- and multi-dose preparations require bactericides
T/F?
False:
only multi-dose containers require bactericides
What is the BP sterilisation method of choice ?
Sterilisation by saturated steam under pressure is preferred, wherever
applicable, especially for aqueous preparations
moist heat
Using steam sterilisation, aqueous preparation requires a minimum heating at 250°C for 15 min
T/F?
False
Using steam sterilisation, aqueous preparation requires a minimum heating at [121°C] for 15 min
Why do some products need to be sterilised?
- avoid infection
- medical equipment/products bypass innate immune system e.g. parentally administered products
What is meant by sterilisation?
Process that kills or remove all types of viable (living) microorganisms including bacterial spores
what products must be sterile?
why?
- Certain classes of medicinal products + equipment
- Parenterally administered products: IV/IM
- any other formulation in contact with eyes, broken skin, internal organs or tissues, want to keep blood sterile
microorganisms present in those items – bypass bodys first line of defence – give rise to severe infection. Don’t want to introduce anything that may cause infection
What is meant by disinfection?
A process that !reduces! the number of viable vegetative microorganisms but does not necessarily kill spores
What is meant by antisepsis?
how do antiseptics compare to disinfectants?
- Prevention of infection by applying antimicrobial agents to tissues
- Antiseptics are less toxic and less effective than disinfectants
What is meant by a viable cell?
One cell capable of division to form a visible colony on solid nutrient medium or visible turbidity in liquid medium (petri dish with agar to see area) can look to see grow/ do turbidity test
What is meant by a dead cell?
A cell that is not capable of division to form a visible colony on solid nutrient medium or visible turbidity in liquid medium