USP <787> Small Volume Testing With Liquid Particle Counters

By Dave Dunham

By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes. USP<787> permits the testing of small volumes (0.2ml-5.0ml) and smaller aliquots than described in USP <788>. Generating accurate data with small sample volumes can be error prone especially due to run to run variances that can skew the data. Small volume testing requires an instrument that can precisely deliver selected volumes while at the same time minimize count errors. The HIAC 9703+ has demonstrated small volume (0.2ml) accuracy that is > 98% and count errors that are < 10%.