STERILITY TEST
Sample Questions
Define sterile products. What are the features in sterile products?
Define clean area. What are the classifications/specifications for clean areas?
Write a detailed account of environmental control in sterile area.
What do you know about the facilities in clean rooms?
What is source of particulate in sterile products? What are several methods for testing of clarity of sterile products?
Write detail account of production of sterile products.
How liquid sterile products are filled into their containers?
What are the in-process quality control tests employed on the sterile products?
Discuss two methods for the testing of clarity/particulate matter in parenteral preparations?
What is purpose and procedure of LAL test? What are the advantages of LAL test over in-vivo
test?
test?
What is the purpose and procedure of rabbit test?
