Podcast
Questions and Answers
What is an example of a microbial contamination source in production processes?
What is an example of a microbial contamination source in production processes?
- Final product testing
- Raw material (correct)
- Air changes and airflow patterns
- Temperature and humidity monitoring
What is a component of environmental monitoring in aseptic areas?
What is a component of environmental monitoring in aseptic areas?
- Putting on sterile hood, mask, suit, overboots, gloves
- Removing outer shoes and clothing
- Airborne nonviable particulate monitoring (correct)
- Water monitoring
What is the principle behind the aseptic area in a sterile products manufacturing unit?
What is the principle behind the aseptic area in a sterile products manufacturing unit?
- Protection against airborne contamination (correct)
- Pressure differential monitoring
- Entry and workflow in different areas
- Temperature and humidity monitoring
What are the steps for entering aseptic areas in a manufacturing unit?
What are the steps for entering aseptic areas in a manufacturing unit?
What is an example of a component of viable contaminant monitoring in a manufacturing unit?
What is an example of a component of viable contaminant monitoring in a manufacturing unit?
What are the typical conditions for dry heat sterilization in a hot air oven?
What are the typical conditions for dry heat sterilization in a hot air oven?
What is the typical absorbed dose of ionizing radiation for heat-sensitive medical devices?
What is the typical absorbed dose of ionizing radiation for heat-sensitive medical devices?
What are the typical conditions for steam sterilization in an autoclave?
What are the typical conditions for steam sterilization in an autoclave?
What are the typical applications of ethylene oxide sterilization?
What are the typical applications of ethylene oxide sterilization?
What are the typical applications of filtration as a sterilization method?
What are the typical applications of filtration as a sterilization method?
