Pharmaceutical Sterilization 2 Flashcards
What are the key considerations in pharmaceutical sterilization
Choice of method
Sterility assurance level
Explain choice of method
Explain sterility assurance level
What are the methods of sterility testing
Direct inoculation method
Membrane filtration method
Explain direct inoculation method
What is the procedure of direct inoculation method
What is done to the inoculated media
What happens after the incubation period
What are the advantages of direct inoculation method
What are the disadvantages of direct inoculation method
Explain the membrane filtration method
What is the procedure of membrane filtration method
What are the advantages of membrane filtration method
What are the disadvantages of membrane filtration method
List the considerations in sterility testing
Sterility assurance level
Test sensitivity
Validation of test methods
Environmental monitoring
Explain sterility assurance level
Explain test sensitivity
Explain validation of test methods
Explain environmental monitoring
List the types of products tested for sterility
What are the common microorganism detected
What is the fluorescence-based detection
What is ATP bioluminescence
What is polymerase chain reaction
What is BacT/ALERT system
Explain the two different regulatory guidelines for sterility testing
