Analysis for Extractables & Leachables from Pharmaceutical container closure systems and single-use processing equipment as well as Medical Device such as implantables and infusion systems.
A critical step in the development of a new pharmaceutical product or medical device is the assessment of Extractables & Leachables (E&L). Chemicals can leach into drug products or patients through the materials used to construct manufacturing equipment, devices or primary and secondary packaging. These leachables can include monomers, oligomers, additives, stabilizers, residual solvents, metals, fillers, dyes, pigments, and catalysts.
Impact Analytical has extensive polymer characterization experience. This experience is leveraged to:
- Fully characterize the packaging, processing equipment, and devices
- Design and conduct appropriate extractables studies that will identify probable leachables
- Validate methods for these targeted compounds
- Conduct both accelerated and real-time leachables studies
- Correlate the leachables to the extractables and identify their source
- Design and conduct routine extractables testing to ensure a consistent supply chain for new batches of container closure systems, manufacturing equipment, and devices
- Provide Toxicological Assessments for all extractables and leachables
Impact Analytical is a cGMP compliant laboratory that has been recently audited by the FDA, with no 483’s issued. All study design and E&L testing is performed according to the latest industry recognized “best practices” including the United States Pharmacopeia (USP), Product Quality Research Institute (PQRI), Bio-Process Systems Alliance (BPSA), and ISO-10993.
Impact Analytical utilizes state-of-the-art laboratory equipment to detect, identify, and quantitate all extractables and leachables. These instruments include:
- Fourier Transform Infra-red Spectroscopy (FT-IR) for material characterization
- DSC and TGA for polymer characterization
- Traditional extraction methodologies – Soxhlet, sonication, agitation
- Accelerated Solvent Extraction (ASE)
- Headspace GC-MS for volatiles
- GC-MS for volatile and semi-volatile organics
- LC-MS, including exact mass for semi- and non-volatile organics
- ICP-MS for trace metals, inorganics
- Ion Chromatography for inorganics