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.
Validation Coordinators use a step-by-step approach, following regulatory requirements and adhering to accepted industry standards, to develop a validation strategy that includes:
- Regulatory compliance
- Product quality
- Risk mitigation
- Patient safety
Validation experts evaluate the criticality of your process train and single-use system, then build a rationale that determines:
- 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)
- 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.