10 Questions
What is an example of a microbial contamination source in production processes?
Raw material
What is a component of environmental monitoring in aseptic areas?
Airborne nonviable particulate monitoring
What is the principle behind the aseptic area in a sterile products manufacturing unit?
Protection against airborne contamination
What are the steps for entering aseptic areas in a manufacturing unit?
Putting on sterile hood, mask, suit, overboots, gloves
What is an example of a component of viable contaminant monitoring in a manufacturing unit?
Viable contaminant monitoring of surfaces
What are the typical conditions for dry heat sterilization in a hot air oven?
160 °C for two hours
What is the typical absorbed dose of ionizing radiation for heat-sensitive medical devices?
25 kGy
What are the typical conditions for steam sterilization in an autoclave?
Dry, saturated steam at 121 °C for 15 minutes
What are the typical applications of ethylene oxide sterilization?
Medical devices
What are the typical applications of filtration as a sterilization method?
Passage of liquid through a bacteria-retentive membrane with a pore size of 0
Test your knowledge of microbial contamination sources in production processes and the methods to build microbiological quality into pharmaceuticals. This quiz covers topics such as flow of personnel, assembly material, cleaning, sterilization, waste, HVAC, facility equipment, raw material, reusable resin, membrane filter, water, gases, validated manufacturing processes, environmental monitoring, and testing.
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