Experts in extractables and leachables studies
VR Analytical, a contract research organization (CRO), has the experience to guide you through qualifying materials for use in bio/pharmaceutical manufacturing. We specialize in designing and performing studies to characterize organic and inorganic chemical entities extracted from materials used in the manufacture, storage, or delivery of pharmaceuticals.
We don’t believe a single approach fits all needs. Instead, we believe that each project requires a complete understanding of our customer's objectives, the materials being used, and the potential interactions that can occur based on a thorough risk assessment of the manufacturing process. Based on these assessments, our team will design a custom study to achieve patient safety and to minimize the potential for regulatory delays.
We offer a spectrum of services starting with consulting and materials assessment through to the characterization of extractables and the facilitation of a toxicology assessment. Using our experience, we design and execute studies that meet your objectives and satisfy regulatory compliance directives.
Frequently Tested Materials
- Final sterilizing-grade filters
- Final containers and packaging delivery systems
- Bags (mixing, storage)
- Sterile and non-sterile filters
- Tangential-flow (cross-flow) filters
- Column chromatography sorbents and chromatography membranes
- Final bulk storage vessels