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Microbial Contamination in Pharmaceutical Production

10 Questions

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Microbial Contamination in Pharmaceutical Production

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Questions and Answers

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?

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?

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?

Putting on sterile hood, mask, suit, overboots, gloves Signup and view all the answers

What is an example of a component of viable contaminant monitoring in a manufacturing unit?

Viable contaminant monitoring of surfaces Signup and view all the answers

What are the typical conditions for dry heat sterilization in a hot air oven?

160 °C for two hours Signup and view all the answers

What is the typical absorbed dose of ionizing radiation for heat-sensitive medical devices?

25 kGy Signup and view all the answers

What are the typical conditions for steam sterilization in an autoclave?

Dry, saturated steam at 121 °C for 15 minutes Signup and view all the answers

What are the typical applications of ethylene oxide sterilization?

Medical devices Signup and view all the answers

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 Signup and view all the answers