Contact VR Analytical today about our Extractables and Leachables Services
Consultation: Many of our clients understand they need more data, but are not sure how to develop the right study, what data will be relevant, or how to acquire it. We can help guide you through this process. Utilize our dedicated team of scientists, analytical equipment, and facility to address your extractables and leachables requirements. Let our depth of knowledge and experience guide your strategy to assess extractables and leachables in your bio/pharmaceutical products.
Materials Assessment: We have years of experience working with a variety of materials and components, and understand the varied sources of extractables. These sources include catalysts used in the manufacture of monomers; polymer additives such as antioxidants, stabilizers, plasticizers and dyes; and degradants of additives that vary depending on age, storage conditions, and sterilization (e.g., gamma radiation or autoclave). We can also perform independent research on product contact materials to help determine their suitability for use and potential for extractables.
Study Design: We develop customized studies to meet our clients' unique needs for information about product contact materials. Our approach ensures that extractables and leachables objectives are addressed, and that specific materials applications are considered.
Controlled Extraction: We employ a variety of extraction techniques in our laboratory, including maceration (solvent soaking), reflux, soxhlet, and sealed vessel via autoclave. We can apply process-simulated pretreatments of rinsing, autoclaving, cleaning and more. We have a unique capability to perform pilot-scale extractions of tangential-flow (cross-flow) filters.
Characterization of Extractables: We employ a range of analytical techniques to characterize the extracts. This is a key process to understanding the potential harm and in what quantities extractables represent a risk to a bio/pharmaceutical development program.
Toxicology Assessment: After extractables or leachables have been identified and quantitated, VR Analytical can facilitate the preparation of a toxicology risk assessments through our association with Intertox Inc. Intertox is a science-based toxicology firm that specializes in risk management and will deliver submission-ready toxicology reports to support worldwide marketing authorization dossiers. The result of this assessment will dictate the next steps for leachables testing.
Leachables Methods: We can develop and validate leachables methods for your products. We can then perform leachables studies on your bio/pharmaceutical products within current regulatory guidelines. Our extractables and leachables experience includes working with many bio/pharmaceutical products, including parenterals.