Sterility Evaluation
The US and EU Pharmacopoeia and FDA Points To Consider (PTC) guidelines describe several techniques for the detection of bacteria in cells or cell-derived products. MDS has developed specific assays in accordance with the main recommendations of the ICH Q5D for unprocessed bulks, cell banks and cells at an age suitable for in vitro production. For cell testing, cells must be grown in the absence of antibiotics for at least two passages prior to testing.
Detection of bacterial and fungal contaminants using a direct inoculation method (2 media):
To test the presence of viable forms of bacteria and fungi, fluid thioglycollate medium (THIO) and tryptone soya broth (TSB) are used. THIO is used for the detection of aerobic and anaerobic bacteria.
TSB is used for the detection of aerobic bacteria and fungi. Test articles are inoculated into these media, incubated at two temperatures and observed for a period of not less than 14 days.
Test for bacteriostatic and fungistatic activity using a direct inoculation method (2 media)
The bacteriostasis and fungistasis test is carried out with a similar methodology to that used in sterility testing and demonstrates that the test article per se does not inhibit the growth of microbial contaminants were the latter to be present.