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SOM 2 > sterile products > Flashcards

sterile products Flashcards

1
Q

definition of bioburden?

A

expression of number of viable organisms a batch has

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2
Q

why do some products need to be sterile?

A
  • avoid infection risk
  • certain classes of products/equipment have to be sterile
  • parenterally administered products
  • use new sterile equipment for each patient especially eye products
  • microorganisms can present and bypass the first line of defence
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3
Q

what are pyrogens and endotoxins?

A

pyrogens are substances that results in temp. increase when administered
- most important one is endotoxin

endotoxins are high MW lips-polysaccharides which are water soluble, heat stable and can pass through bacteria proof filters
- inactivated with dry heat at high temp of 170-350

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4
Q

what are best and worst case scenarios of having a non-sterile product?

A

best case:

  • micro-organisms induce spoilage of products
  • identify issue before usage
  • batch or product is destroyed before use

worst case:

  • infection
  • death
  • microbial survival not identified before use
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5
Q

what is the definition of antisepsis?

A

prevention of infection by applying antimicrobial agents to tissues
- less toxic and less effective than disinfectants

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6
Q

what type of sterile formulations, products or devices could you get?

A
  • injections; IV infusion, TPN fluids, small vol injections
  • non-injectable sterile fluids
  • ophthalmic preparations
  • dressings
  • implants
  • absorbable haemostats
  • surgical material
  • instruments and equipment
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7
Q

what are the general requirements for containers for sterile product?

A
  1. chemically compatible with product
  2. withstand sterilisation
  3. maintain product sterility
  4. permit safe withdrawal of product
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8
Q

what types of containers can you have for products?

A
  1. large vol parental; rigid and flexible, glass and plastic
  2. small vol parentals; ampoules, vials, syringes
  3. irrigations; glass and plastic, satchets
  4. eyedrops; glass and plastics
  5. eye ointments; plastics
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9
Q

what is the difference between single dose and multi dose containers?

A

single dose containers hold a quantity of the preparation intended for total/partial use as a single administration
e.g. intraspinal injections and IV injections cant contain bactericides
multi-dose containers holds a quantity suitable for > 2 doses
- require a bactericide
- must have an excessive number of doses

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10
Q

Advantages and disadvantages for using glass as sterile fluid container?

A

+ good chemical resistance
+ neither absorbs or elutes organic ingredients
+ impermeable
+ easily cleaned and transparent
+ rigid and strong and resists puncture
+ can be autoclaved at 121 degrees or dry heat sterilisation
- breakage in sterilisation
- attack by alkaline solution
- can develop hair-line cracks and much heavier than plastic
- need inspection and washing
- need sealing by closures

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11
Q

Advantages and disadvantages for using plastic as sterile fluid container?

A 
\+ relatively unbreakable 
\+ light and easily fabricated 
\+ cheap and single use
\+ small filling points 
\+ possible to seal
- additives are in plastic 
- sterilisation of fluid in plastic packs so container must be protected 
- cannot match barrier properties of glass to moisture and oxygen
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12
Q

what plastic polymers can be used for sterile fluid containers?

A
  1. Polyvinyl chloride -
    - used widely and is flexible
    - used in blood bags, catheters and IV tubes
    - (CH2- CHCl)n
  2. Polyethylene
    - withstand sterilisation so high MP
    - loss of flexibility
    - high opacity
    - (CH2- CH2)n
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13
Q

how are ampoules, vials, bottles and containers be closed?

A
  • glass ampoules are closed by fusion
  • vials and bottles need some form of closure
  • containers, plastic ones, can be closed by fusion
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14
Q

what properties do we need for elastomeric closures?

A

compressibility and resealability

- these closures are in most contact with product

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15
Q

what are some factors affecting the selection of a rubber closure?

A
  • active drug substance
  • the vehicle
  • buffer system
  • product pH
  • preservatives
  • colour
  • moisture/gas protection
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16
Q

what do sterile products need to be protected from?

A
  • chemical or particulate contamination
  • from degradation
  • microbiological contamination
  • pyrogenic contamination
  • physical damage from sterilisation and handling
  • parental container must be sealed
  • > avoid leaks or cracks
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17
Q

what are the BP labelling requirements?

A 
for all preparation:
- name of product
- names and proportions of medicaments 
- names and proportions of added preservatives
- batch number
for injections:
- amount of API in suitable dose vol.
- name and proportion of any added bactericide/preservative 
- name of buffer or stabilising agent 
- storage conditions 
- expiry date
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18
Q

what should sterile products labels include?

A

a. name of product
b. pharmaceutical form
c. strength and official name
d. quantity of product
e. direction of use
f. contra-indications
g. special handling/storage conditions
h. expiry date
i. name and address of holder of product license
j. product license number
k. batch reference
l. keep out of reach of children
m. any warning or special requirements
n. POM - if needed

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19
Q

Why do micro organisms pose a problem to pharmacists?

A

They are small

  • abundant
  • may cause disease
  • some spores are resistant to killing by chemicals or heat or drying or radiation
20
Q

Where should sterile medicinal products be prepared?

A 
Specially designed and constructed manufacturing departments 
Should be in a separate area
Should generally be sterile and clean 
Different operations must be separate from each other like:
- component prep 
- solution prep 
- filling
- sterilisation
21
Q

What kind of personnel should be present in these conditions?

A

They should have high standards of personal hygiene and cleanliness

  • report any infections
  • there’s a minimum amount of personnel that should be present
  • > limited activities to avoid excessive shredding of microorganisms
  • no jewellery or makeup or nail polish
  • needs adequate training
22
Q

What conditions need to be regularly monitored with sterile products in the sterile area?

A
  1. Air velocity and pressure
  2. Particulate contamination
  3. Temp and humidity

Should keep watch and should see what went wrong if it doesn’t run smoothly

23
Q

What methods can you use a measurement of aerial contamination?

A

A. Settle plates
- nutrient plates capture AC which settle by gravity
- important hazard
- small particles are not represented and are unaware of air volume that is introduced
B. Slit samplers
- air is drawn through slits
- under these slits there is a nutrient agar plate that rotates
- deposition of particles depend on air flow rate, slit dimension and distance between holes and plate
Helps to count organism number that is associated with particles

24
Q

What is particle sediment rate dependant on?

A

On size
The particle sediment can be resuspended when air is distributed
Airborne bacterial spores remain viable for a long time depending on humidity and nutrient availability

25
Q

How should air in sterile areas be kept?

A

Kept sterile by being supplied and continuously flushed with air of suitable quality and at a positive pressure
Through high efficiency particulate air filters of appropriate efficiency
Outside air that is dirty has a lower pressure

26
Q

what are some lethal agents and if exposed how do cells react?

A

lethal agents can be heat or ionisation
but they can be viable or dead and after exposure the population of viable cells will not all die at the same time
the reduction occurs over time

27
Q

what is meant by a constant proportion?

A

it is meant where it is not a constant number of organisms is killed per unit time

28
Q

what does sterility assurance level mean?

A

the probability of single viable microorganisms occurring on a cell after sterilisation

29
Q

what is meant by the D value?

A

it is the decimal reduction value

expression of the rate at which microorganisms are inactivated by sterilisation process is needed

30
Q

what is the definition of inactivation factor?

A

reduction in the number of viable organisms produced by sterilising process

31
Q

what are the two approaches to sterilisation?

A
  1. overkill method
    - basis of traditional BP methods of heat sterilisation
    - minimum SAL is set
    - overkill a reference of these microorganisms to get a certain sterility level
  2. bioburden method
    - prior to defining sterilisation cycle
    - allows minimal product deterioration
    - need knowledge of bioburden, D value and most resistant organisms in bioburden
32
Q

what type of products are terminally sterilised and non-terminally sterilised?

A
  • terminally sterilised products are one that are sterilised in their final containers
  • > manufactured in cleanroom and are pyrogen free products
  • > must have low microbial and particulate counts prior to sterilisation
  • non terminally sterilised products are ones prepared under aseptic conditions from previously sterilised materials
  • > processed in cleanrooms
33
Q

what are the different methods of sterilisation?

A
  • dry heat sterilisation
  • filtration; non terminally sterilised products
  • ionising radiation sterilisation
  • steam sterilisation ; heating in an autoclave
34
Q

what is heat sterilisation? why and how is it done?

A
  • used as heat is most reliable and versatile and available for the method
  • very safe compared to chemical processes
  • heat will increase the rate of chemical reactions so higher growth rate
    the materials must be stable e.g. containers, the decomposition of drug

heat can have a destructive effect on more heat sensitive components

35
Q

what is the effect of heat on bacteria?

A
  • when you increase temp, eventually
    no. of organism dying = no. of organisms reproduced
    = this is bacteriostasis
  • a further temp. increase means there will be a destructive bactericidal effect
    -> death rate increases and decrease sterilisation time
36
Q

what does sterilisation depend on?

A

the time/temp. relationship

37
Q

what are heat resistant microorganism?

A
  • vegetative bacteria are relatively heat sensitive
  • killed rapidly in hot water 60-100 degrees
  • spores need temp >100
  • resistance depends on heat
    e. g. clostridium tetani or bacillus stearothermophilus
38
Q

what is the difference between dry heat and moist heat?

A

moist heat is in the presence of water and dry heat has absence of water
for moist heat the mechanism of destruction is done by protein denaturation(unfolding protein), enzyme inactivation
moist heat has a relatively lower temp. and is a method of choice whereas dry heat requires high temp and oxidation of cell components
dry heat needs more energy for protein unfolding; their proteins are much more stable to dry heat

39
Q

what is steam sterilisation?

A

heating in an autoclave

  • under pressure
  • heating at 121 degrees for 15 min
  • saturated steam used ; water vapour at appropriate temperature
  • steam has a higher heat content than water
40
Q

what is meant by sensible heat and latent heat?

A

sensible heat is the heat required to raise water to its BP temp
latent heat is the additional heat that’s absorbed when boiling water is converted to steam

41
Q

what are the dis/advantages of moist heat?

A

+ terminal sterilisation
+ any dose volume
+ good safety margin
+ viruses killed
+ suitable for dressing rubber and plastics; also suitable for solutions, suspension
- unsuitable for thermo-labile material and anhydrous materials
- organisms are not removed only killed
- need skilled operators
- can damage glass and metal and is a batch process

42
Q

what is dry heat sterilisation?

A
  • sterilised by dry heat, distributed into final container and then sealed
  • heated at an effective combination of time and temp e.g. 30 min at 180
  • used for thermostable items
  • high temps, >250 degrees, for sterilising glassware
  • done for anhydrous materials, powders, rubbers, glass and metals
43
Q

what are the dis/advantages of dry heat?

A 
\+ terminal sterilisation 
\+ any dose volume and viruses are killed
\+ used for anyhrous materials and suitable for solutions and suspension
\+ less damage to glass and metals 
- drastic heat treatment 
- organisms not removed only killed
- not for dressing, rubber and plastics
- suspensions can give a crystal form when cooling
44
Q

what is sterilisation by filtration?

A
  • organisms are removed as well being killed
  • solutions or liquids sterilised by passage through a sterile membrane filter of nominal pore size 0.22 micrometers or less
  • the preparation and API are not heat stable so autoclaving can occur
45
Q

what are the dis/advantages of filtration?

A

+ no thermal effects
+ removes dead and viable organisms
- difficult and requires sterility testing prior
- won’t remove inactive viruses
- detects in filters not visible
- unsuitable for suspensions
- can have medicament adsorption occurring or alteration of pH by filter

46
Q

what is ionising radiation sterilisation?

A
  • terminal sterilisation
  • exposure of the product in its final container to ionising radiation
  • gamma radiation which is penetrating
  • beta radiation which has poor penetration and is high speed e-
  • has physical and biochemical effects in microorganisms
  • minimum absorbed dose of 25 kGy - the SI unit of dose defined as 1 joule of energy absorbed / kg of material irridiated
47
Q

what are the dis/advantages of ionising radiation sterilisation? what are the applications used?

A 
\+ operates at ambient temp
\+ terminal sterilisation 
\+ continuous process
\+ reliable and accurately controlled
\+ short treatment time 
- expensive 
- can have damaging effect on some materials and need protective precautions

applications

  • heat sensitive materials
  • dressing and organic compounds

SOM 2 (10 decks)

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