Extractables and Leachables
Ensure patient safety and safeguard product quality
Safeguard your biopharmaceutical products by evaluating extractables and leachables (E&L) from contact materials like filters and single-use systems. Our risk-based approach assesses potential patient safety risks, including toxicity and compliance with global standards (Biophorum, USP, and GMP guidelines). Overall, our services facilitate compliance while supporting your validation strategy, from component selection to final drug product safety.
An easier way to achieve a seamless and robust E&L assessment
Collect
Compile standard extractables data for contact material present in the process, including BioPhorum protocol and USP <665> approaches
What?
Extractables Dossiers:
- Enabling initial qualifi cation
- Ensuring product functionality
- Assuring material safety
Emprove® Program
- Operational Excellence Dossiers
- Mobius® Assemblies Advanced Qualification Dossiers (AQD)
Interpret
Identify process specific extractables in drug product by interpreting standard extractables data (model streams, scale, timepoints)
What?
Process Specific Extractables Report: Quantitative list of process specific extractables (or potential leachables)
Where?
Validation Services
Extractables Study Service
Evaluate & Mitigate
Calculate risk associated to drug intake on the basis of extractables compounds
If evaluation fails, mitigate risk with a leachables study or change process design
What?
Patient Safety Report
Leachables Report
Where?
Validation services
- Patient Safety
- Evaluation Service
- Leachables Study Service
Maximize
Maximize efforts toward assuring patient safety
We provide thorough risk-based assessments that include:
- Risk level assessment and consultancy: Review product and manufacturing process to determine level of risk to patient safety.
- Extractables testing: Identify compounds that can be extracted from plastic or elastomeric materials under aggressive conditions.
- Leachables testing: Evaluate compounds that may leach into drug products under normal use conditions.
- Safety assessments: Assess the safety of the single-use/filtration system by our in-house toxicologists
The resulting extractables or leachables data package either proves and affirms the E&L safety of your manufacturing process or establishes the need for additional evaluation. Millipore® Validation Services can further help you mitigate risks with flushing studies and alternative process designs.
Related product resources
- Brochure: Validation services extractables and leachables testing
Ensure patient safety with our E&L validation services, providing comprehensive chemical profiling of single-use systems for biomanufacturing. Assess and mitigate risks from product contact materials in drug production effectively.
- White paper: The role of BPOG extractables data in the effective adoption of single-use systems
Guidance for evaluating single-use systems for extractables and leachables.
- Webinar: Navigating EU GMP Annex 1
This webinar describes a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post-approval processes.