Release testing of raw materials and final products

• Assay
• Impurities, incl. trace contaminants (nitrosamines, aromatic amines, dioxins etc.)
• Residual solvents
• Microbiology

Method development and validation according to ICH guidelines; method optimization

R&D support

• Structure elucidation including assignment or prediction of complex molecules
• Identification and quantitation of transformation or degradation products
• characterization of complex formulations
• Failure analysis

Stability testing

• Storage according to ICH guidelines
• Analytical testing
• Identification of transformation or breakdown products
• On-line kinetic measurements

Qualification of reference materials

Extractables and leachables studies for medical devices

• Leachability or migration studies
• Identification and quantitation of extractables and leachables
• Determination of the role of additives in polymer formulations
• Recommendations for alternative stabilizers to achieve lower leachability
• Formulation of polymer test samples to evaluate potential leachables

Numetrika™:  Antimicrobial efficacy and adhesion testing for medical and other devices and products

• In vitro testing methodology for evaluating adhesive and antimicrobial performance
• Numetrika™ is therefore a valuable tool for R&D purposes to determine appropriate concentrations of antimicrobials needed and their homogenous distribution
• Numetrika™ supports quality control measurements for the medical device industry
• Numetrika™ can be utilized to evaluate the effects of surface treatments on microbial adhesion and/or proliferation

Please consult also information on Numetrika at:
http://www.bio-gate.de

Testing for Pharma & Medical Device Industries
(pdf, 286 KB)

Providing Analytical Solutions and Consultancy to the Pharmaceutical and Medical Device Industries