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PY365 Quality Of Sterile Medicines > Ionising radiation as a sterilising agent > Flashcards

Ionising radiation as a sterilising agent Flashcards

1
Q

what is radiation

A

radiation is energy travelling through space
- some forms of radiation are ionising

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2
Q

what are the 2 main types of radiation

A

electromagnetic and particulate

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3
Q

give examples of electromagnetic radiation

A

gamma rays, X rays, UV, infrared, visible light

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4
Q

give examples of particulate radiation

A

a-particles, B-particles (high speed electrons), neutrons, protons

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5
Q

What is meant by ionising

A

can add or remove electrons from molecules, producing electrically charged ions

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6
Q

what are the types of waves on the electromagnetic spectrum

A
  1. radio
  2. microwave
  3. IR
  4. visible
  5. ultraviolet
  6. X ray
  7. gamma rays
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7
Q

name the different units of radiation

A
  1. activity of a source
  2. absorbed dose
  3. energy of radiation
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8
Q

what are the units of activity of a source

A

Becquerel (bq)
- 1 bq= 1 nuclear disintegration per second

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9
Q

what are the units of absorbed dose

A

Gray (Gy)
- 1 Gy= the absorption of 1 Joule of energy per Kg of material

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10
Q

what are the units of energy of radiation

A

electron volts (eV) or millions of electron volts (MeV)

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11
Q

describe the characteristics of gamma rays in ionising radiation

A
  1. short wavelength, ionising, high energy and highly penetrating
  2. usually 60Co source
  3. gamma rays bombard the materials which results in emission of lower energy photons and electrons
  4. items pass in a zig zag pattern around the source
  5. exposure time is long
  6. standard reference dose is 25Gy
  7. specialised process with high safety control
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12
Q

what occurs in the generation of gamma ray radiation

A

Cobalt source emits 2 photons and one electron

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13
Q

list the organisms from least sensitive to most sensitive to ionising radiation

A
  1. prions
  2. viruses
  3. bacterial spores
  4. yeast and fungi
  5. vegetative bacteria (gram - most sensitive)
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14
Q

how can ionising radiation have a lethal affect

A
  1. direct hits- direct alterations to the target, usually DNA
  2. indirect effects- free radical and peroxide formation
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15
Q

what are the applications of gamma radiation

A
  1. thermolabile products
  2. single use technologies
  3. disposable syringes
  4. range of plastics
  5. lab ware and culture media
  6. IV and infusion sets
  7. adhesives and dressings
  8. prostheses
  9. unit dose ointments
  10. dry pharmaceutical products
  11. metal instruments
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16
Q

what are the advantages of gamma radiation

A
  1. high penetrability
  2. cold process
  3. not dependent on humidity, temperature, pressure or vacuum
  4. does not generate residuals
  5. does not generate radioactivity
17
Q

what are the disadvantages of gamma radiation

A
  1. specialised facilities/training
  2. high costs
  3. safety considerations- risk to operator
  4. deleterious effects on products
  5. no inactivation of endotoxin
18
Q

what are the deleterious effects on plastics

A
  • cross linking
  • chain scission
    -odour formation
  • discolouration
  • embrittlement
  • stiffening
  • softening
  • enhanced or reduced chemical resistance
  • increased or decreased melting point
19
Q

what are the deleterious effects of pharmaceutical products

A

may undergo alteration or degradation

20
Q

what are the deleterious effects of aqueous environments

A

damage through radiolysis of water

21
Q

what products may be affected by deleterious effects

A

plastics, glass, pharmaceutical products and aqueous environments

22
Q

what do accelerated electrons (particulate) produce

A

high energy electron beam generated by accelerated electrons from a hot filament through an evacuated tube under high potential difference
- various machines produce electrons with energy of 5-10MeV

23
Q

What are the advantages of accelerated electrons

A
  1. rapid dose delivery, therefore shorter process times than for gamma rays
  2. direct ionisation of molecules
24
Q

what are the disadvantages of accelerated electrons

A

less penetrating than gamma rays

25
Q

describe the properties of ultra violet radiation

A
  1. non ionising
  2. less lethal and damaging than ionising radiation
  3. causes excitation not ionisation
  4. induces linkages between adjacent pyrimidine bases
    - dimer formation (usually thymine)
26
Q

list in order from least resistant to most resistant to the microbicidal action of UV radiation

A
  1. vegetative bacteria
  2. yeasts
  3. viruses
  4. bacterial spores
  5. mould spores
  6. prions
27
Q

what are the applications of UV radiation

A
  1. poor penetrating power, not practical for pharmaceutical/medical products
  2. application as a disinfection agent
  3. air
  4. work areas and surfaces
  5. manufacturing grade water
  6. microbiological safety cabinets
28
Q

what is gamma radiation

A

A terminal sterilisation process allowing for parametric release

PY365 Quality Of Sterile Medicines (19 decks)

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