Relequa Analytical Systems Ltd services
Statistical Precision and Assurance Services
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.
Risk Management & Compliance Services
Relequa's Moisture Profiling™ is an advanced method specifically designed to measure moisture movement in pharmaceutical products, providing precise insights into their stability. Unlike conventional techniques like Loss-on-Drying or Dynamic Vapour Sorption, which rely on weight metrics, Moisture Profiling measures moisture status changes due to water vapor exchange. This method ensures reproducibility and accuracy by analyzing how moisture interacts with materials under fluctuating environmental conditions. It is particularly vital in evaluating the stability of drug products and choosing optimal packaging that mitigates moisture impact, especially valuable in clinical trials and product development stages. Moisture Profiling effectively reveals the moisture barrier properties of packaging materials such as blister packs, allowing for informed decisions in pharmaceutical manufacturing. Any deviations in moisture equilibrium and barrier effectiveness are quickly identified, ensuring product quality and reducing the risk of stability issues.
Relequa - Risk Management & Compliance Services
At Relequa our R&D people over the past 7 years have focused on gaining an understanding of the way materials interact with moisture. We have identified the key parameters involved in the initial stages of water vapour moving from the surrounding air into a material. Knowing how these parameters influence moisture uptake has allowed us to build precision into Relequa’s new Moisture Profiling™ system, the MP-1000.