By combining fast and sensivtive analytical techniques with its experience and scientifc excellence, Solivas has the capabilities to support your pharmaceutical development process with efficient extractable and leachable testing for
- container closure systems (incl. inhalation devices and syringes)
- production process materials (incl. disposable systems)
- medical devices.
Our services meet the requirements of the FDA, EMEA, ISO and are performed in accordance to the latest recommendation from consortias such as PQRI and BPSA.
Our offer includes but is not limited to:
- Consulting on experimental design, risk assessment and regulatory issues
- Controlled extraction studies
- Leachables studies, including sample storage under controlled conditions (stress conditions and/or in accordance to ICH)
- Development and validation of analytical methods for routine extractable testing (QC).
- Development and validation of analytical methods for leachables studies.
- Toxicological evaluations and recommendations
Customers benefit from a well established effient workflow and experience:
- Fast and efficient sample preparation through semi-automated extraction equipment
- Reliable results through vigorous extraction with multiple solvents, use of multiple extraction techniques and use of complimentary analytical techniques
- Fast generation of results through Solvias's proprietary and continously growing database with more than 3000 substances that are potential extractables and leachables.
- Ready acceptance of reports by regulatory agencies through Solvias's recognized high standards as a provider to the pharmaceutical industry and full GMP compliance (FDA, Swissmedic).
Analytical techniques for EL studies includes:
- GC-MS (for semi-volatiles)
- GC-HS-MS (for volatiles)
- LC-MS (for "non-volatiles" and as complimentary method for GC)
- IEX-LC (for ions)
- ICP-MS (elemental and heavy metal screening)
- Numerous other techniques as needed
Extractables and leachables testing is embedded in Solvias's well established analytical services departement which provides access to know-how and instrumentation in numerous analytical techniques and strategies.