IC4

Question 1

what is sterility assurance level

Answer 1

• probability of one viable microorganism in a certain number of drug products
  ** -1 log: probability of finding 1 microorganism out of 10 loads of single containers = 10^1
  ** - 2log: probability of finding 2….. = 10^2
  ** usually 10^6

Question 2

what is positive control for suitability test

Answer 2

how much microbe can grow without preservative

Question 3

what is negative control for suitability test

Answer 3

nothing can grow.

Question 4

what is the point of growth promotion test

Answer 4

1) ensure growth medium allows microorganism to duplicate/grow
2) ensure medium produce consistent results

Question 5

what to do before growth promotion test

Answer 5

each medium incubated & assessed for sterility

Question 6

endotoxin test

Answer 6

1) endotoxin limit concentration (ELC) = max endotoxin dose / max recommended dose
2) max valid dilution (MVD) = ELC / method sensitivity

Question 7

requirement for sterile product

Answer 7

1) no microorganism
2) endotoxin inside limit
3) no detectable particles

Question 8

what is the point of aseptic process stimulation

Answer 8

validate aseptic process using microbiological growth medium as substitute for product & employing method that closely approximate those used during drug product process

Question 9

how does aseptic process stimulation work

Answer 9

• basically just to test every component of sterilisation process
• if test once and approved but change something afterwards = redo process again

Question 10

what can you use aseptic filtration for

Answer 10

• thermolabile objects
• remove bacteria/mould
• remove protein based products that cannot withstand heat

Question 11

what is the point of aseptic filtration

Answer 11

remove pyrogens

Question 12

what can you not use aseptic filtration for

Answer 12

viruses/mycoplasma

Question 13

lyophilization (freeze drying) - most commonly used for what products

Answer 13

vaccines

Question 14

lyophilization (freeze drying) - tldr of process

Answer 14

1) quick freezing
2) primary drying (sublimation)

• dry w heat under vacuum + remove aq vapour
• end point = when temperature of sample start rising

3) secondary drying (desorption)

• under vacuum to ensure ice X melt but go from solid to gas
• end point = when water content < 1%
• stoppper vials in low humidity to maintain product stability

Question 15

what is lypophilisation used for

Answer 15

CHATGPT SAYS its for preservation of sterility