EUROLABoffers a comprehensive approach to Extractables and Seals testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined into a tailored approach for our customers.
EUROLABis equipped with the latest analytical technology such as:
All instruments are dedicated to extractable and leaky testing for the pharmaceutical industry that requires all analytical equipment to be fully qualified (IQ / OQ / PQ) - and optimized for methods.
In addition to standard Pharmaceutical Extractables and Leak Test programs, EUROLABUsing GC-ToF-MS, LC/MS-Orbitrap, LC-ToF-MS, FT-MS can help elucidate structural information for critical compounds.
Due to the high importance of unique identification of material impurities during extractable and leaky runs, EUROLABhas created a “library” of more than 1.000 reference standards for trace contamination testing in polymers and rubbers. These reference standards are used to confirm the identity (via retention time or mass spectral confirmation) of extractable/leachable compounds.
EUROLAB It also offers storage capacity under controlled temperature and humidity for a variety of different storage conditions to support the stability program for leaky runs. Climate chambers are fully qualified and monitored with a central data recording system.
Our team of analytical experts can work with aqueous buffered saline solutions, more complex pharmaceutical formulations (eg) and even very complex matrices (eg oily solutions, syrups, ointments).
Polymer Information and Regulatory Guidelines
Although E&L-trace assay testing often presents significant challenges to the analytical development team and therefore requires a high level of analytical expertise, a comprehensive understanding of polymers and rubbers is equally important, along with an in-depth knowledge of global regulatory requirements. This combined expertise is of great importance both in the development phase of a testing strategy for a specific E&L project and in understanding and interpreting the analytical results obtained and evaluating these data from a regulatory perspective. EUROLAB The packaging solutions department has experience in the medical and pharmaceutical industries with successful validations covering multiple product, package and sterilization configurations.
ISO 10993 Biocompatibility and E&L
E&L services are part of a complete medical device biocompatibility testing program after ISO 10993. This program includes a series of tests and Toxicological Risk Assessments.
EUROLAB, with its highly expert team and internationally accredited laboratories, Pharmaceutical Extract and Leakproof Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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