The MF Biocompatible VPP Framework — Monomer-Free Formulation as a Regulatory Engineering Strategy
Segurola, Juan
This white paper presents the MF Biocompatible VPP Framework, positioning monomer-free formulation as an engineering strategy for reducing regulatory, toxicological and extractables-related risk in professional manufacturing workflows.
Biocompatibility is not only a material label. It depends on formulation architecture, residual species, cleaning, post-processing, final device design, intended use, extraction behaviour and legal-manufacturer validation. MF formulation reduces one relevant risk axis within that broader pathway.
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DOI de esta versión 10.5281/zenodo.22047929 · Todas las versiones en Zenodo