01 - 6 - 2014 |
D3.4 - Detailed cost of good analysis and safety assessment of the size measurement and quantification system
An evaluation of the UV and MALS (multi-angle light scattering) detection systems, the related prototypes and the expectations for the final detection modules has been performed. The two systems were assessed in relationship with the existing regulatory requirements in the EU and in North America. Critical attention was given to evaluating the two systems in terms of laboratory safety, possible environmental hazards, costs and procedural limits. Both procedures provide comparable safety and efficacy. Both systems present appreciable safety levels and a high correlation score for linear correlation between the signal produced and the tested concentrations of nanoparticles. Neither the UV- technique nor the MALS-detector present complications that would prevent compliance to the existing European or North American regulation. Both systems are expected to be compatible with GLP guidelines and international laboratory standards.