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:
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.
Extractables and Leachables (E&L) 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. BioReliance® Validation Services can further help you mitigate risks with flushing studies and alternative process designs.
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