Question

Name the fungus used for positive control sterility testing

Answer 1

For positive control, three sterilized three finished products shall select at random. Spike about 1ml of suspension of one type of the following organisms: Staphylococcus aureus ATCC 6538, Candida albican ATCC 10231 and Clostridium sporengenes into each of the 3 samples.

Answer 2

Sterility testing is designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use.  A bacteriostasis/fungistasis test is also performed to assess whether or not the test article inhibits the growth of microorganisms.