Manufacturing of Sterile Dosage Forms

Which of the following sources are potential contaminants of the clean room?

• Human

• Raw material

• Air

• Processing method

What does HVAC stand for?

• Heating, ventilation and air

• Heating, ventilation and air conditioning

• Heating , ventilation and air cooling

• Heating, ventilation and air solutions

This picture shows an example of _______________.

• Personnel airlock

• Material airlock

• Isolator

• Cleanroom

This is an example of _______________ laminar flow station.

• Turbulence

• Horizontal

• Vertical

• Diagonal

This laminar flow station is suitable for the compounding/ reconstitution of __________________________.

• cytotoxic drugs

• total parenteral nutrition

• vaccine

• radiopharmaceuticals

Which laminar flow station offers greater operator protection?

• Horizontal

• Vertical

• Both types

• None of them

During high-risk level compounding, sterile ingredients or components are exposed to air quality ________________.

• equal to ISO Class 5
• higher than ISO Class 5
• higher than ISO Class 8
• lower than ISO Class 5

Sterility assurance level (SAL) is also known as ___________.

• probability of non-sterile unit

• colony forming unit

• clinical microbiology unit

• sterility testing unit

Sterility assurance level must be

• equal and smaller than 10^-4

• equal and smaller than 10^-5

• equal and smaller than 10^-6

• equal and smaller than 10^-7

Limulus Amebocyte Lysate (LAL) test is specific for the detection of _________________.

• peptidoglycans

• biofilm

• lipopolysaccharides

• β-glucans