Biomanufacturing Production

What does the acronym "API" stand for?

• Active parenteral intervention

• Active process ingredient

• Active pharmaceutical ingredient

• Active practice indicator

What describes the process of converting ice to steam/vapor?

• Sublimation

• Simplification

• Condensation

• Distillation

What is the manufacturing process of adding ingredients and mixing them together called?

• Filtration

• Compounding

• Computation

• Chromatograpy

What is the process of producing a biological molecule using a single-celled organism such as bacteria, yeast or fungi?

• Cell division

• Fermentation

• Sublimation

• Sterilization

What is the process of removing liquids (usually water) from solid material by applying negative pressure?

• Lyophilization

• Dispensing

• Decomposition

• Filtration

What is name of any component in a finished drug product that does not have a pharmacological effect?

• Protein

• Active pharmaceutical ingredient

• Extraction

• Excipient

Answer explanation

Excipients such stabilizers, salts, or bulking agents are componentsn finished drug .products, but do not have a pharmacological effect

What is the process called in which containers are filled and closed before the product is sterilized in its container?

• Cleaning in Place

• Terminal sterilization

• Aseptic processing

• Typical sterilization

What is any component intended to furnish pharmacological activity or other direct effect in a diagnosis or cure, as well as a component that affect body structure or function in people or animals?

• Raw material

• Material specification

• Active pharmaceutical ingredient

• Excipient

___________ are product containers that contain growth promoting media in a known quantity of microbes placed in equipment to confirm terminal sterilization.

• Biological indicators

• Temperature sensors

• pH meters

• Sample vials

Common sterilization methods include which of the following?

• Moist heat

• Thermal density

• Irradiation

• Bioburden management

• All of these

Answer explanation

Moist heat, thermal density, irradiation and bioburden management are all commonly used sterilization methods.