The Sieve-ID(TM) method with MuScan(TM) analysis is validated according to USP[1223] and Ph.Eur 5.1.6 at Innosieve Diagnostics, but is also being internally evaluated and validated at major pharmaceutical companies. The results show to be at least non-inferior to the compendial methodology for bioburden testing. All pharmacopoeia recommended reference strains have been evaluated, giving great precision and highly reliable quantification. The overall limit of reliable detection was found to be 1-5 FFU per volume with accurate quantification up to high contamination levels.
