Extractables &
Leachable Studies
Risk-based GMP-certified E&L assessments for pharmaceutical packaging, medical devices, and single-use systems, ensuring patient safety through migrant quantification.
Securing the Container-Product Interface
Molecules migrating from packaging materials or manufacturing equipment can significantly compromise the safety and stability of therapeutic drug products. At BrownBiology Laboratory, we follow a rigorous risk-based methodology aligned with the latest regulatory mandates.
Our specialized E&L unit navigates the complexities of material characterization, establishing safety concerns thresholds (SCT) and executing validated leachable programs across all delivery formats鈥攆rom vials and syringes to complex medical devices and single-use bioprocessing systems.
Consult Our E&L Specialists 鈫?/a>
Lifecycle E&L Management
From initial material vetting to final dosage form validation.
Controlled Extraction (CES)
Vigorously extracting potential migrants from materials under exaggerated conditions to identify the complete structural chemical profile of the material.
Simulation Studies
Bridging the gap between extraction and leachable studies by menggunakan solvents that simulate the drug product's actual formulation and pH.
Leachable Validation
Validating analytical methods within the actual drug product matrix to quantify target leachables throughout the intended shelf-life.
Toxicological Assessment
Establishing Analytical Evaluation Thresholds (AET) and performing risk-based safety assessments for identified migrants.
Target System Expertise
Container Closures
Glass vials, rubber stoppers, pre-filled syringes and blister packaging.
Single-Use Systems
Bioprocessing bags, specialized tubing, connectors and filtration modules.
Medical Devices
Drug delivery devices, respirators, and complex integrated medical equipment.