Boston Analytical Now Offering Extractables and Leachables Testing Services
(Salem, NH) May 23, 2016 — Boston Analytical, the Life Sciences Division of Alpha Analytical, recently began offering Extractables Leachables testing services. With this new service line Boston Analytical is able to better serve existing clients and gain access to new clients with Extractables & Leachables (E&L) testing needs. E&L testing complements the drug development testing support services currently offered by Boston Analytical, and positions the company to be a one-stop shop for testing needs in the pharmaceutical and medical device industries.
Extractables & Leachables have become a concern given the increased use of plastic in drug packaging and medical devices. Recent guidance by the Unites States Pharmacopeia (USP) addresses the risk of leachables from plastic packaging. Boston Analytical's approach follows this guidance and is designed to provide support that assures patient safety and prompt product approval. This process includes an initial risk assessment of all primary and secondary contact materials with the drug product. This plan can be included with regulatory filings to document the proactive, risk-based approach. Boston Analytical follows appropriate regulatory guidances and industry best practices including: PQRI best practices, ISO 10993, and USP <661.1>, <661.2>, <661.3>, <1663>, <1664>, <1664.1>. All studies are documented to full cGMP standards and methods are validated per ICH guidelines.
To launch the new service line Boston Analytical has compiled a staff of experienced scientists. "The team has over 15 years of experience performing plastic and packaging characterization for Extractables & Leachables," states Eric Hill, Director of Extractables & Leachables Laboratories at Boston Analytical. "Members of our team are active in industry E&L groups including PQRI and USP, and have worked directly with the FDA to ensure compliance. It was important that we assemble an experienced team to allow us to service clients immediately without a learning curve. We have experience with all types and forms of products and packaging including: metered dose inhalers, blister packs, pre-filled syringes, drug delivery patches, drug delivery pumps, bottles, caps, single use systems, stents, and process components."
For more information on the Extractables & Leachables Services available at Boston Analytical, or to begin working with Boston Analytical on your Extractables & Leachables project, please contact them at email@example.com or (603) 893-3758.