MilliporeSigma

Extractables and Leachables

BioReliance® extractables and leachables testing services

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

Extractables Dossiers
Why?
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
Where?
Operational Excellence Dossiers

    Interpret

    Extractables Data
    Why?
    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

      Leachables Report
      Why?
      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

        Patient Safety

        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. 


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