Sterile & Non-Sterile Preparations Flashcards

What is the definition of a 'clean room' in pharmaceutical manufacturing?

Answer: A controlled environment with defined limits for airborne particulate contamination, maintained at specified temperature, humidity, and pressure

A clean room is an engineered environment with controlled air quality (particle counts, temperature, humidity, and pressure differentials) to prevent contamination during pharmaceutical manufacturing and compounding.

Which quality parameter must be tested in all parenteral preparations to ensure patient safety?

Answer: Sterility, pyrogen/endotoxin testing, particulate matter, and pH

Parenteral preparations must pass sterility testing, pyrogen/endotoxin testing, visible and sub-visible particulate matter inspection, and pH verification before release to ensure patient safety.

What is the role of a humectant in topical pharmaceutical preparations?

Answer: To attract and retain moisture in the skin, preventing dryness and improving drug absorption

Humectants such as glycerol and propylene glycol attract water from deeper skin layers and the environment to the stratum corneum, hydrating the skin and supporting drug penetration.

Which process is used to remove bacteria and particulates from heat-sensitive pharmaceutical solutions?

Answer: Membrane filtration using a 0.22 µm filter

0.22 µm membrane filtration (cold sterilisation) effectively removes bacteria and particulate matter from heat-sensitive solutions without exposing them to damaging temperatures.

What does 'preservative efficacy testing' evaluate in multi-dose pharmaceutical preparations?

Answer: The ability of the preservative to inhibit microbial growth throughout the product's shelf life after opening

Preservative efficacy testing (antimicrobial effectiveness testing) challenges the preparation with specified microorganisms to confirm the preservative maintains adequate antimicrobial protection over the stated shelf life.

Why is it critical to check compatibility before admixing two drugs in the same IV bag?

Answer: Physical or chemical incompatibility can cause precipitation, degradation, or reduced potency, leading to patient harm

Drug incompatibilities in IV admixtures can produce visible precipitate or invisible chemical degradation that reduces drug potency or creates toxic products, posing serious patient safety risks.