Verification is essential to ensure product quality and patient safety. For decades, Alfa Chemistry has been a trusted partner for extractables and leachables (E&L) verification, including customer-specific solutions. Our risk-based approach can help medical product manufacturers determine the best process for scaling up from the laboratory to commercial production.
Why Is Extractables and Leachables Testing Needed?
As the utilization rate of one-off systems increases, the importance of E&L testing is also increasing. When a drug product comes into contact with disposable ingredients, leachables can accumulate in the drug product and may endanger the safety of the patient either directly or by interfering with the active drug ingredient. Extractables and leachables testing is a regulatory requirement to prove that the degradation products of plastic materials used in medical product processing will not cause harm to patients.
How We Help You to Succeed
Alfa Chemistry's E&L service can meet all your verification needs. Each customer's strategic approach can be customized for specific processes and needs. During the initial evaluation, our expert team will consider your drug development stage, route and frequency of administration, product quality parameters, and steps in the manufacturing process. We provide correct verification for all products in the process chain, including container closure systems, filters, and disposable systems.
We provide an extractables guide, which introduces the methods and results of internal extractables and leachables research of all our products, and identifies almost all extractable compounds. The guide provides:
- Identify all relevant extractables
- Quantification of extractables
- Extractable Toxicology Information
Through extractables evaluation, it is possible to evaluate the substances found in the standard extractables analysis in a reasonable worst case for individual customer processes. This enables you to fully understand and trust the Alfa Chemistry components used in your process.
In addition to our extractables assessment, we also provide extractables research to identify and avoid potential leachables in your final drug product. Extractables research is exactly what you need when choosing suitable packaging materials or processing equipment, such as in the development of pharmaceutical products. We create extractable data based on your personal requirements.
Our team provides complete leachable analysis, including leachable screening analysis or special leachable target analysis. Using our especially evaluated and certified methods, we can detect known leachables in consumables in almost all complex pharmaceutical solutions.
Our safety assessment uses extractables or leachables results from extractables assessments or studies or leachables tests, and correlates the data with the patient's condition. After understanding the patient's drug application, we can calculate the daily possible intake of potential leachables.
Why Choose Us？
For many years, Alfa Chemistry has had professional knowledge and has always been a leader in the E&L field, which means that we bring a deep understanding of extractables science to each client project.
- Optimize turnover
- Reduce verification costs
- Flexible scaling of extractables
- Comprehensive extractable profile
We have developed our own method for characterizing extractables. We use a combined method to determine the extractables profile to achieve the best material characterization and verification so that the potential leachables in all consumables can be evaluated more reliably and in detail.
Our customers benefit from:
- Proven data scalability
- Comprehensive extractable profile
- High-quality data derived from the most advanced analytical methods