The determination of Extractables and Leachables in bio/pharmaceutical products is an important measure in drug product development, qualification, and regulatory submission. Emphasis on this type of testing has grown in the last number of years, initially seen in the PQRI Guidelines for Extractables and Leachables, to those observed changes to Extractable and Leachable USP related standards. It is critical to ensure the materials that come into contact with your product do not affect the safety or efficacy of your product and its ultimate affect to the patient.  To ensure your drug product is safe, and to satisfy the FDA Extractable and Leachable testing expectations, we offer comprehensive E&L testing services to assist in the evaluation of the manufacturing process including single use systems (SUS), final container/closure, delivery devices, and overall packaging configuration of your product.

Our E&L studies are based on the recommendations of the Product Quality Research Institute’s (PQRI) Extractables and Leachables Working Group to the FDA, USP <1663>, USP <1664>, the recommendations of Bio-Process Systems Alliance (BPSA) Extractables and Leachables subcommittee, FDA container closure guidance, and ISO 109993-18, Chemical characterization of materials in Biological evaluation of medical devices, utilizing each or all guidance as appropriate.

EXTRACTABLE AND LEACHABLE SERVICES

  • Development of a Tailored Extractable and Leachable Study Design
  • Development of optimized protocols based on pertinent guidelines
  • Controlled Extraction Studies
  • Extractable Profiling and Identification
  • Simulation Studies
  • Leachable Studies on Drug Product over Shelf Life and/or Accelerated Stability Program
  • Extractable and Leachable Method Development, Validation,and Routine Testing

EXTRACTABLE AND LEACHABLE INSTRUMENTATION

Whitehouse Laboratories uses state-of-the-art instrumentation to produce high-quality data and submission-ready results when conducting your Extractable and Leachable Studies. Our instrumentation ranges from general analytical equipment to specialized systems for E&L Testing.

  • HPLC-MS, UPLC-MS, HPLC-MS/MS, HPLC-High Resolution MS
  • HPLC-UV/CAD/ELSD, UPLC-UV/CAD/ELSD
  • HS-GC-MS, GC-MS, GC-FID, GC-ECD
  • ICP-OES, ICP-MS, IC
  • FTIR, NMR
  • TGA, DSC

PRODUCTS WE TEST:

  • Medical Devices
  • Containers
  • Container Closure systems
  • Raw materials
  • Single use systems
  • Manufacturing components including rubber closures for parenteral products
  • Primary and secondary packaging

At Whitehouse Laboratories, we perform method development and validations for necessary analytical techniques according to ICH guidelines and in full compliance with cGMP requirements. Additionally, we can provide comprehensive support and expertise by conducting toxicological risk assessments on the extractables and leachables data to meet FDA and global regulatory submission requirements towards the demonstration of safety.

Please contact us at Whitehouse labs to better understand how we can guide you through the process in meeting your Extractables & Leachables needs.