What is Batch Validation in HPLC Column Production?
The variation between different batches or lots of packing material can best be eliminated by strict control of the manufacturing process and also extensive testing using tight specifications for each batch. Minimum criteria are established for retention, selectivity (k), efficiency (N), asymmetry and tailing factor. Tight specifications and a greater variety of test probes assures greater reproducibility in the final product. Single Test Validation Figure 3 shows an example of a single chromatographic validation test. This test is somewhat effective in that acidic, neutral and basic test probes are used, but the test is carried out under only one set of mobile phase conditions. In addition, the amount of information obtained from this single test is minimal and does little to assure batch reproducibility. There is a specification for retention relative to acenaphthene, but there is no specification given for acenaphthene (hydrophobic) retention. USP tailing factors are specified for b
