This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products.
An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.
A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities.