Rapid Sterility Testing

The final sterility test is perhaps the most critical step in providing a safe injectable drug.  Traditional methods are effective but take 14 days and CSPs are often limited in shelf lives so robust rapid microbiology testing is an effective way to ensure patient safety.

Current regulations support the use of alternative methods:

"A method not described in the USP  may be used if verification results demonstrate that the alternative is at least as effective and reliable as the USP Membrane Filtration method or the USP Direct Inoculation of the Culture Medium method were the Membrane Filtration method is not feasible."  -USP<797>

The ScanRDI® gives compounders power to verify sterility of filterable samples in as little as three hours.  The BacT/ALERT® offers a rapid solution for non-filterable samples.

Learn more about bioMerieux's rapid alternative microbiology solutions:

 

*The use of any alternative method requires user validation.