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Extractables & Leachables


Demonstrate that patient safety is not adversely affected by the plastic product-contact materials

Understanding the potential leachables and their effects on patient safety is a critical step in a validation strategy. Our Extractables & Leachables (E&L) services evaluates the customers process and product-contact material and assess the identity and quantity of potential leachables in the final drug product and their potential toxicity to patients. As per regulatory expectations, extractables is evaluated initially, if there is increased risk during the patient safety evaluation then leachables may be required.

A thorough interpretation of the extractables datasets combined with an evaluation of the criticality of your process train and single-use system can help determine:
  • Single-use components to be evaluated
  • Choice of analytical method
  • Model solvent(s)
  • Relevant worst-case conditions
To demonstrate that filtration devices and single-use systems materials utilized in pharmaceutical and biopharmaceutical manufacturing will not adversely affect a drug product’s safety for patients, we assist you in conducting a risk assessment and recommend a validation strategy with a step-by-step approach.
  • Extractables Evaluation
    • Data will be compiled through our analytical studies or via our Emprove® Program. Through the Operational Excellence Dossiers for Filters and Single Use Systems, the Emprove® Program provides a unique set of extractables profile aligned with industry standardized practices such as the BPOG's standardized extractables testing protocol for single-use systems in biomanufacturing and USP general chapter.
  • 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, manufacturing process and drug posology are used to calculate the potential daily intake of the potential Leachables compared to the exposure limits.
  • Leachables Testing
    • When required, a leachables study is conducted using end-user process conditions and products to identify compounds from the single-use systems, followed by a toxicity assessment.
The resulting Extractable 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.

A Seamless and Robust E&L Assessment

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Learn how BioReliance® Validation Services for extractables and leachables can help ensure the safety of your patients.