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PY365 Quality Of Sterile Medicines > Sterilisation by Filtration > Flashcards

Sterilisation by Filtration Flashcards

1
Q

what is the aim of filtration

A

removes microorganisms, rather than killing them

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2
Q

what is sterilising filtration

A

removal of all microorganisms, except viruses
- not a terminal sterilisation process
- test for sterility required on final products

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3
Q

outline the desirable qualities of filters for parenteral solutions

A
  1. removes particles above a given size
  2. the flow rate must be acceptable
  3. can be sterilised by steam
  4. be both flexible but mechanically strong
  5. minimal fibre shedding or chemical release
  6. minimal sorption from product
  7. non pyrogenic
  8. resist clogging
  9. biologically inert
  10. easily cleaned
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4
Q

what are the 2 main types of filters

A
  1. depth filters
  2. membrane filters
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5
Q

what are the 3 main processes of preparing membrane filters

A
  1. gelling and casting
  2. track (irradiation) etch
  3. expansion process
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6
Q

what is the pore size controlled by in gelling and casting of membrane filters

A

controlled by polymer concentration, mixing process, solvent used and the drying method

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7
Q

what is the pore size controlled by in track etching of membrane filters

A

pore size/density determined by both the duration of exposure to charged particles and the etching process

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8
Q

what do pleated membrane filters provide

A

provide increased surface area

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9
Q

compare the properties of membrane filters and depth filters

A
  1. membrane filters- retention of organisms greater than the rated pore size
    depth filters- retention difficult to characterise due to irregular and poorly defined pores
  2. membrane filters- rigid, uniform with controlled pore size
    depth filters- random matrix of bonded particles
  3. membrane filters- sterilising filters
    depth filters- mainly used as pre-filters
  4. membrane filters- fast filtration speed
    depth filters- slow filtration speed
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10
Q

what are the considerations for the selection of sterilising grade filters

A
  1. requires assessment of the filter, the product and the demands placed upon the filter
  2. appropriate flow rate and volume
  3. pressure and temperature resistance of the filter and its housing
  4. compatibility of all product contact surfaces with the process
  5. membrane composition
  6. sterilisation
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11
Q

what are the application of filtration methods

A
  1. thermolabile solutions and fluids which it is not possible to terminally sterilise
  2. soluble solids
  3. air (HEPA filters)
  4. other gases
  5. venting systems
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12
Q

what are the advantages of filtration methods

A
  1. particle removal- both viable and non viable cells are removed
  2. can process large volumes semi continuously
  3. processing can be carried out at ambient temperature
  4. pyrogens are not generated
  5. filter material can be varied according to the product
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13
Q

what are the disadvantages of filtration methods

A
  1. post filtration aseptic processing is necessary
  2. possibility of some sorption of active ingredients
  3. existing pyrogens are not removed
  4. viruses and mycoplasmas may not be removed
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14
Q

what does qualification involve

A
  • physical and chemical compatibility
  • binding and adsorption
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15
Q

what does validation involve

A
  • retention of bacteria
  • integrity testing
  • toxicity/extractables testing
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16
Q

define sterilising filter

A

filter which, when challenged with the microorganism Brevundimonas diminuta at a minimum concentration of 10^7 organisms per cm2 of filter surface, will produce a sterile effluent

17
Q

what is involved in the testing of filters for liquid application

A
  1. microbial challenge test- suspension of brevundimonas diminuta
  2. physical integrity tests- bubble point test, diffusion test and pressure hold test
18
Q

what is involved in the release of filtered products

A
  1. adherence to documented procedures
  2. documented filter type
  3. details of system sterilisation
  4. filter integrity testing
  5. sterility test results
19
Q

when can gaseous sterilisation be used

A

may be used for items which cannot withstand high temperatures or for items sensitive to radiation

20
Q

what does EtOX form

A

forms explosive mixtures with air, issues with toxicity and no standard cycle available
- requires sterility testing

PY365 Quality Of Sterile Medicines (19 decks)

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