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Extractables & Leachables

Answering Critical Safety Questions

Proving that leachate from your process isn’t harmful to the final drug product is easier for you with BioReliance® Validation Services. Our extractables and leaching (E&L) services thoroughly evaluate all contact materials and processes to reduce or prove harmless reactive, additive or absorbative concerns to process fluids.

To demonstrate that filtration devices and single-use systems materials used in biopharmaceutical manufacturing will not adversely affect a drug product’s safety for patients, BioReliance® E&L conducts a risk assessment and recommends a validation strategy.

Validation Coordinators compile data from existing sources and analytical studies and combine it with our knowledge of our products and your process.

This 360-degree review fully answers critical process technology questions to maintain product safety, identity, strength, purity and quality.

E&L Services

  • Regulatory compliance
  • Product quality
  • Risk mitigation
  • Patient safety

Validation Coordinators use a step-by-step approach, following regulatory requirements and adhering to accepted industry standards, to develop a validation strategy that includes:
  • Product Contact Material Safety Risk Assessment and Consultancy
  • Extractable Certification or Testing (if needed)
  • Extractable Toxicity Assessment, using in-house toxicologist – not third parties
  • Leachable Study and Toxicity Assessment (when required)

Validation experts evaluate the criticality of your process train and single-use system, then build a rationale that determines:
  • Single-use components to be tested
  • Choice of analytical method
  • Model solvent(s)
  • Relevant worst-case conditions

The resulting Extractable and 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 help you mitigate problems with flushing studies and alternative process designs.
  • Learn how E&L BioReliance® Validation Services can help ensure the safety of your drug product.