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PY513 Infectious Disease and
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Questions and Answers |
Exam Prep
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PY513: Infectious disease and Global health
Study online at https://quizlet.com/_guwl8w
1. What is sterilization? Process that completely destroys all microbial life
2. What is the need for sterilisa- Sterilisation is essential in pharmaceutical manufacturing
tion in pharmaceutical manufac- to prevent contamination of drugs, vaccines and med-
turing? ical devices, ensure patient safety by eliminating harmful
microorganisms, comply with regulatory standards set by
organisations like the FDA and WHO and maintain product
efficacy and shelf life.
3. What needs to be sterilised? -Raw materials
-Final products
-Equipment and instruments
-Packaging materials
4. Why are different sterilisation -Some materials cannot withstand high temperatures
methods required? -Some microorganisms are more resistant and require
more aggressive sterilisation methods
-industrial scale sterilisation demands efficiency, cost ef-
fectiveness and safety
5. What are common sterilisation -heat sterilisation
methods? -Filtration
-radiation
-chemical sterilisation
6. What is moist heat sterilization? Using pressurised steam (121•C -134•C) to kill microbes
Pros: Highly effective, fast and non-toxic
Cons: Not suitable for heat-sensitive materials and can
damage certain drugs.
7. What is dry heat sterilization?
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Uses hot air (160•C-180•C) to kill microbes.
Pros: suitable for heat stable products.
Cons: Slower than moist heat, requires higher tempera-
tures.
8. What are some properties of an -High Antimicrobial activity
ideal sterilisation method? -Easily controllable/measurable/understood physical
conditions for microbial inactivation.
-Terminal sterilisation
-Material compatibility
-No hazard to operator
-No toxic residues
-Short Processing time
-Low cost
Need to balance advantages/disadvantages.
9. What is terminal sterilisation? When a product is made under non-sterile conditions
using non-sterile ingredients then sterilise it at the end of
the process.
10. What is aseptic manufacturing? Make the product from sterile ingredients under sterile
conditions.
11. What are methods of sterilisa- -Dry heat
tion recommended by the British -Steam sterilisation
Pharmacopoeia? -ionising radiation
-Gas sterilisation
-filtration
12. What are some key points of -sterilisation by thermal conduction
sterilisation by dry heat? -Heat stable, moisture stable products
-Process: heat up -> sterilisation —> cool down
-Action through coagulation and oxidative processes
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PY513: Infectious disease and Global health
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-killing less effective in absence of moisture, reflected in
processing times.
-SAL of 10^-6 or better
13. What is depyrogenation? Depyrogenation is the process of removing pyrogens,
which are fever inducing substances from pharmaceutical
products, equipment and packaging materials.
14. What are pyrogens? Typically endotoxins which are toxic components of the
outer membrane of gram-negative bacteria. Even if bac-
teria are killed during sterilisation, their endotoxins can
remain and cause severe reactions such as fever, inflam-
mation or even septic shock in patients.
15. Why is depyrogenation impor- - patient safety: Pyrogens can cause fever, hypotension and
tant? severe immune responses.
-pharmaceutical quality: injectable drugs, intravenous flu-
ids and medical devices must be free from pyrogens to
ensure they are safe for human use.
-regulatory compliance: guidelines from the FDA, EMA and
USP require depyrogenation for sterile products.
16. What are advantages of dry heat -simple method
sterilisation? - effective method- heat conduction reaches all surfaces
-where hydration is undesirable
-protection of cutting edges
-avoids 'wet pack' problems
-No chemical residue
-Depyrogenation possible
17. What are some disadvantages of -less efficient than steam at the same temperature
dry heat sterilisation? -limitations for plastic/rubber items
-uneven/slow heat transfer
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PY513 Infectious Disease and
Global Health Practice
Questions and Answers |
Exam Prep
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PY513: Infectious disease and Global health
Study online at https://quizlet.com/_guwl8w
1. What is sterilization? Process that completely destroys all microbial life
2. What is the need for sterilisa- Sterilisation is essential in pharmaceutical manufacturing
tion in pharmaceutical manufac- to prevent contamination of drugs, vaccines and med-
turing? ical devices, ensure patient safety by eliminating harmful
microorganisms, comply with regulatory standards set by
organisations like the FDA and WHO and maintain product
efficacy and shelf life.
3. What needs to be sterilised? -Raw materials
-Final products
-Equipment and instruments
-Packaging materials
4. Why are different sterilisation -Some materials cannot withstand high temperatures
methods required? -Some microorganisms are more resistant and require
more aggressive sterilisation methods
-industrial scale sterilisation demands efficiency, cost ef-
fectiveness and safety
5. What are common sterilisation -heat sterilisation
methods? -Filtration
-radiation
-chemical sterilisation
6. What is moist heat sterilization? Using pressurised steam (121•C -134•C) to kill microbes
Pros: Highly effective, fast and non-toxic
Cons: Not suitable for heat-sensitive materials and can
damage certain drugs.
7. What is dry heat sterilization?
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PY513: Infectious disease and Global health
Study online at https://quizlet.com/_guwl8w
Uses hot air (160•C-180•C) to kill microbes.
Pros: suitable for heat stable products.
Cons: Slower than moist heat, requires higher tempera-
tures.
8. What are some properties of an -High Antimicrobial activity
ideal sterilisation method? -Easily controllable/measurable/understood physical
conditions for microbial inactivation.
-Terminal sterilisation
-Material compatibility
-No hazard to operator
-No toxic residues
-Short Processing time
-Low cost
Need to balance advantages/disadvantages.
9. What is terminal sterilisation? When a product is made under non-sterile conditions
using non-sterile ingredients then sterilise it at the end of
the process.
10. What is aseptic manufacturing? Make the product from sterile ingredients under sterile
conditions.
11. What are methods of sterilisa- -Dry heat
tion recommended by the British -Steam sterilisation
Pharmacopoeia? -ionising radiation
-Gas sterilisation
-filtration
12. What are some key points of -sterilisation by thermal conduction
sterilisation by dry heat? -Heat stable, moisture stable products
-Process: heat up -> sterilisation —> cool down
-Action through coagulation and oxidative processes
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PY513: Infectious disease and Global health
Study online at https://quizlet.com/_guwl8w
-killing less effective in absence of moisture, reflected in
processing times.
-SAL of 10^-6 or better
13. What is depyrogenation? Depyrogenation is the process of removing pyrogens,
which are fever inducing substances from pharmaceutical
products, equipment and packaging materials.
14. What are pyrogens? Typically endotoxins which are toxic components of the
outer membrane of gram-negative bacteria. Even if bac-
teria are killed during sterilisation, their endotoxins can
remain and cause severe reactions such as fever, inflam-
mation or even septic shock in patients.
15. Why is depyrogenation impor- - patient safety: Pyrogens can cause fever, hypotension and
tant? severe immune responses.
-pharmaceutical quality: injectable drugs, intravenous flu-
ids and medical devices must be free from pyrogens to
ensure they are safe for human use.
-regulatory compliance: guidelines from the FDA, EMA and
USP require depyrogenation for sterile products.
16. What are advantages of dry heat -simple method
sterilisation? - effective method- heat conduction reaches all surfaces
-where hydration is undesirable
-protection of cutting edges
-avoids 'wet pack' problems
-No chemical residue
-Depyrogenation possible
17. What are some disadvantages of -less efficient than steam at the same temperature
dry heat sterilisation? -limitations for plastic/rubber items
-uneven/slow heat transfer
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