Inter and Intra Lot Validation: Performance attributes

MiniWick+ Performance Attributes

The MiniWick+ Nitrocellulose (NC) membrane has been validated for inter- and intra-lot variation in key parameters like capillary flow rate and thickness variability. By streamlining manufacturing processing and optimising membrane surface chemistry, Minipore offers MiniWick+ NC membranes with high consistency and low variation in critical parameters, i.e., capillary flow rate and thickness. These critical parameters directly correlate with the uniformity in pore rating and performance during the actual assay. Typical %CV (coefficient of variation) values for capillary flow rate and membrane thickness vary between 2-4 percent.
Qualification of manufacturing process and product quality are assured with validation studies where intra-lot sample analysis has been conducted with 20 measurements across the length of a 100-metre reel of three different lots and on the contrary, an inter-lot study has been done for mean data of six lots produced over a period of six months.