#StatCheck

Question 1

What level of accuracy are powders measured to?

Answer 1

1 mg; e.g. 0.422g or 422mg

Question 2

What level of accuracy are volumes measured to?

Answer 2

1 decimal place; e.g. 10.5mL

Question 3

What is the nominal pore size specified in the B.P. for sterilisation via filtration?

Answer 3

0.22μm or less (micrometres)

Question 4

How many particles are dispersed per minute from rapid mobility (e.g. walking/climbing stairs)?

Answer 4

10,000,000 (LOADS)

Question 5

How far does a sneeze travel compared with saliva during coughing and normal talking?

Answer 5

Sneeze: 10-15 feet
Coughing: 4-6 feet
Normal talking: 2-3 feet

Question 6

What is the test dose for Ambisome IV Infusion?

Answer 6

• 1 mg over 10 minutes

- Patient observed for 30 minutes

Question 7

What is the minimum in-line filter membrane pore diameter for AmBisome?

Answer 7

• 1.0 μm

- Don’t want to filter out drug

Question 8

What is the shelf-life of Ambisome after reconstitution?

Answer 8

Up to 7 days when stored at 2-8 Degrees Celsius.

Question 9

How often should an operator complete and pass a BTT to continue manufacturing sterile products?

Answer 9

Every 3 to 6 months.

Question 10

How long is a settle plate incubated for in a BTT and at what temperature?

Answer 10

• 24 hours

- At 37 Degrees Celsius (mimic body’s environment)

Question 11

What is the minimum number of items to be tested as part of a batch of more than 200 containers, as part of quality assurance?

Answer 11

10 containers

Question 12

What is the minimum number of items to be tested as part of a batch of less than 200 containers, as part of quality assurance?

Answer 12

• 5%
• Or 2 containers
  (whichever is greater)

Question 13

As part of sterility testing (quality control), what is the maximum filter pore size sized to pass a sample through? (to retain particles/micro-organisms)

Answer 13

0.45 μm or less.