Extractables and Leachables
Understanding the potential of leachables to affect patient safety is a critical step in the validation strategy of any biopharmaceutical manufacturer. Our Extractables & Leachables (E&L) services will consider a risk-based approach to determine if patient safety is adversely affected by plastic materials coming into contact with the final drug product during your process, while assessing potential toxicity to patients.
In accordance with regulatory expectations, our E&L team will conduct a thorough interpretation of the extractables datasets while evaluating the criticality of your process train and single-use system. We can determine:
- Single-use components to be evaluated
- Choice of analytical method
- Model solvent(s)
- Relevant worst-case conditions
Seamless and robust E&L assessment
To demonstrate that filtration devices and single-use systems materials utilized in your manufacturing will not adversely affect a drug product’s safety for patients, we assist you in conducting a risk assessment and recommend a step-by-step validation strategy.
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
EMPROVE® PROGRAM
What?
Extractables Dossiers:
- Enabling initial qualifi cation
- Ensuring product functionality
- Assuring material safety
Operational Excellence Dossiers
Interpret
Identify process specific extractables in drug product by interpreting standard extractables data (model streams, scale, timepoints)
VALIDATION SERVICES
What?
Process Specific Extractables Report: Quantitative list of process specific extractables (or potential leachables)
Where?
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
VALIDATION SERVICES
What?
Patient Safety Report
Leachables Report
Where?
Patient Safety
Evaluation Service Leachables Study Service
Maximize
Maximize efforts toward assuring patient safety
- Extractables evaluation. By considering a worst-case and a model solvent approach, extractables data will be compiled through our analytical studies or via our Emprove® Program.
- Patient safety assessment. A patient safety evaluation is performed by an in-house toxicologist to determine the potential risk to patients. Extractables and/or leachables data, the manufacturing process, and drug posology are used to calculate the potential daily intake of potential leachables compared to exposure limits.
- Leachables testing. When required by a risk-based approach, a leachables study is conducted using end-user process conditions and products to identify compounds from the filtration device and single-use systems, followed by a patient safety assessment.
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. Validation Services can further help you mitigate risks with flushing studies and alternative process designs.
Request a quote and get started today.
Related Product Resources
Validation Services Extractables and Leachables Testing Brochure
Article: The Landscape for Single-use Systems
Webinar: BioPhorum Raw Materials Risk Assessments
Webinar: Advances in E&L Testing for Single-use Process Technology
White paper:The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems
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