The precision built into Relequa’s Moisture Profiling™ gives a high level of assurance where product reliability is important. Our software has an option for running in 21 CFR Part 11 compliant mode. Statistical precision (Repeatability, Intermediate Precision and Reproducibility) provides you with reliable Point-To-Point data that allows you to make the decision that the moisture status of a product has changed, or remains within specification. The same data within Quality Assurance will show a Regulatory Authority that your product has remained within its moisture specification.

Point-To-Point analysis is required in:

  • Storage of Intermediate Bulk Product
  • Controlled Room Temperature (CRT) shipping
  • Time Points on a Stability Testing Protocol

In the graph, moisture profiles are shown for desiccated tablets (to maintain the same moisture status) tested on consecutive days. The table shows the measured WVEP and the Precision that is achieved.

mpstats2-chart

When a change in moisture status has occurred, often due to moisture ingress, then a change in the Moisture Profile is seen, resulting in a different Water Vapour Equilibrium Point (WVEP).

mpstats3-diagram

FREE POSTER FOR MOISTURE BARRIER PROPERTIES

See our poster “Study of a Range of Blister Packaging Materials Using the New Technique of Moisture Profiling to Give Early Indications of Moisture Barrier Properties” that shows how the barrier effectiveness in three types of packaging were differentiated in just one day at ICH Q1A(R) real time and accelerated stability conditions.

download-poster