Study Set Content:
Method B
Semi quantitative gel clot method
Method C –
Kinetic Turbidimetric Method
Method D –
Kinetic Chromogenic Method
Method E –
End-point Chromogenic Method
A photometric assay measuring the increase in turbidimetry caused by the reaction of the endotoxin with the lysate
Kinetic Turbidimetric Method
A photometric assay measuring a color developed by the chromophore released from a chromogenic substrate by the reaction of the endotoxin with the lysate
Kinetic Chromogenic Method
defines as freedom from the presence of viable microorganisms
Sterility
is defined as microbiological test applied to sterile product to show that the product are manufactured and processed under specification guided by cGMP.
Sterility test
Media used sterility test
Fluid Thioglycolate Medium • Soybean-casein Digest Medium
Method A
Membrane filtration Method
Method B-
Direct Inoculation Method
The whole contents of each container
less than 1 ml
Half the contents of each container but not less than 1 ml
1-40 mL
20 ml
Greater than 40 ml and not greater than 100 ml
10 percent of the contents of the container but not less than 20 ml
Greater than 100 ml
1 ml
Antibiotic liquids
Minimum number of items to be tested
Not more than 100 containers
10 percent or 4 containers whichever is the greater
More than 100 but not more than 500
10 containers
More than 500 containers
2 percent or 20 containers for large-volume whichever is the less
If the material being tested renders the medium turbid so that the presence or absence of microbial growth cannot be easily determined by visual inspection, 14 days after the beginning of incubation, transfer portion of the medium to fresh vessels of the same medium and then incubate original and transfer vessel for not less than
4 days
