{"id":1338,"date":"2018-10-14T15:29:00","date_gmt":"2018-10-14T13:29:00","guid":{"rendered":"http:\/\/tpm.bio\/?page_id=1338"},"modified":"2024-12-09T12:57:02","modified_gmt":"2024-12-09T11:57:02","slug":"top","status":"publish","type":"page","link":"https:\/\/tpm.bio\/en\/labs\/top\/","title":{"rendered":"TOP"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; back_color=&#8221;color-gyho&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_single_image media=&#8221;207&#8243; media_width_use_pixel=&#8221;yes&#8221; alignment=&#8221;center&#8221; media_width_pixel=&#8221;110&#8243;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;400&#8243; text_color=&#8221;accent&#8221;]Toxicology and Performances for regulatory compliance[\/vc_custom_heading][vc_column_text]The &#8220;Toxicology and Performances for regulatory compliance&#8221; laboratory (TOP) has recognized and consolidated experience in the following macro-activities that are delivered accordingly to the international sector regulations and through advanced methodologies. Furthermore, the TOP laboratory supports in study protocols elaboration and identifies the best in vitro and in vivo analysis approach to evaluate the materials activity.[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; border_color=&#8221;accent&#8221; border_style=&#8221;solid&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1522831730782{border-right-width: 1px !important;}&#8221;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]The activities[\/vc_custom_heading][vc_custom_heading text_weight=&#8221;400&#8243; text_color=&#8221;accent&#8221;]Toxicology:[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1733745319513{padding-right: 20px !important;}&#8221;]<\/p>\n<ul>\n<li>Chemical characterization as per ISO 10993-18 (Leachables and Extractables) on medical devices in order to assess the migration of organic compounds (non-volatile, volatile and semi-volatile) and inorganic elements. These activities are performed within a quality management system :<\/li>\n<\/ul>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>ISO 9001 (generic quality system)<\/li>\n<li>ISO 13485 (medical devices quality system)<\/li>\n<li>GLP (good laboratory practice)<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<ul>\n<li>Protocols and activities related to set up and validation of analytical spectroscopic and chromatographic methods.<\/li>\n<li>Consulting on certification for CE marking, registration of medical devices in extra European countries, certificates renewal as per MDR 745 (2017) requirements and MDCG guidelines.<\/li>\n<li><strong>Examples:<\/strong><\/li>\n<\/ul>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>Toxicological Risk Assessment (TRA) (ISO 10993-Part 17)<\/li>\n<li>Biological Evaluation Report (BER)<\/li>\n<li>Biological Evaluation Plan (BEP)<\/li>\n<li>Clinical Evaluation Report (CER)<\/li>\n<li>Clinical Evaluation Plan (CEP)<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p>[\/vc_column_text][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]Application sectors[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1539523409026{padding-left: 40px !important;}&#8221;]<strong>Dental<\/strong><br \/>\n<strong>Pharmaceutical<\/strong><br \/>\n<strong>Cosmetic<\/strong><br \/>\n<strong>Agro-food<\/strong><br \/>\n<strong>Biomedical<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;70&#8243; back_image=&#8221;451&#8243; parallax=&#8221;yes&#8221; overlay_color=&#8221;color-jevc&#8221; overlay_alpha=&#8221;30&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; mobile_height=&#8221;400&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; back_color=&#8221;color-gyho&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column width=&#8221;1\/1&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]Scientific Supervision:[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1527498099281{padding-left: 40px !important;}&#8221;]Prof. Aldo Tomasi MD[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]Laboratory Head[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1668080381483{padding-left: 40px !important;}&#8221;]Dott. Simone Roncioni[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_separator sep_color=&#8221;accent&#8221;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]Staff and skills[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1733744716877{padding-left: 40px !important;}&#8221;]<strong>Dott. Simone Roncioni<\/strong>, Laurea Magistrale in Scienze Chimiche<br \/>\n<strong>Dott. Francesco Burini<\/strong>, Laurea Magistrale in Scienze Biomolecolari e Cellulari<br \/>\n<strong>Dott. Luca Accorsi<\/strong>, Laurea Magistrale in Scienze Chimiche<br \/>\n<strong>Dott.ssa Elena Rebecchi<\/strong>, Laurea Magistrale in Scienze Chimiche<br \/>\n<strong>Dott. Lorenzo Morelli<\/strong>, Laurea Magistrale in Scienze Chimiche<strong><br \/>\nMarco Palella<\/strong>, Tecnico Superiore per l\u2019innovazione, sviluppo e produzione di medical devices[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/1&#8243;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]Equipment[\/vc_custom_heading][vc_column_text css=&#8221;.vc_custom_1733745419577{padding-left: 40px !important;}&#8221;]<strong>Toxicology<\/strong><\/p>\n<p>Ultra performance liquid chromatography &#8211; Electrospray ionization &#8211; High resolution mass spectrometry (UPLC-ESI-HRMS)<br \/>\nUltra performance liquid chromatography \u2013 UV spectroscopy (UPLC-PDA)<br \/>\nGas chromatography &#8211; Electronic ionization &#8211; Low resolution mass spectrometry (GC-EI-MSq)[\/vc_column_text][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column width=&#8221;1\/1&#8243;][vc_gallery el_id=&#8221;gallery-142032&#8243; type=&#8221;carousel&#8221; medias=&#8221;739,740,741,742,743,744,745,736,737,738&#8243; carousel_lg=&#8221;4&#8243; carousel_md=&#8221;3&#8243; carousel_sm=&#8221;1&#8243; thumb_size=&#8221;four-three&#8221; gutter_size=&#8221;1&#8243; carousel_interval=&#8221;3000&#8243; carousel_navspeed=&#8221;400&#8243; carousel_loop=&#8221;yes&#8221; carousel_nav=&#8221;yes&#8221; carousel_nav_mobile=&#8221;yes&#8221; carousel_dots_mobile=&#8221;yes&#8221; stage_padding=&#8221;0&#8243; single_overlay_opacity=&#8221;50&#8243; single_padding=&#8221;2&#8243; single_border=&#8221;yes&#8221;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column width=&#8221;1\/1&#8243;][vc_custom_heading el_class=&#8221;elemento_piu_h2&#8243;]SEM Analysis[\/vc_custom_heading][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column width=&#8221;1\/1&#8243;][vc_gallery el_id=&#8221;gallery-142035&#8243; medias=&#8221;750,751,752,749&#8243; gutter_size=&#8221;3&#8243; screen_lg=&#8221;1000&#8243; screen_md=&#8221;600&#8243; screen_sm=&#8221;480&#8243; single_width=&#8221;3&#8243; images_size=&#8221;four-three&#8221; single_overlay_opacity=&#8221;50&#8243; single_padding=&#8221;2&#8243; single_border=&#8221;yes&#8221;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243;][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243;][vc_button size=&#8221;btn-lg&#8221; radius=&#8221;btn-square&#8221; border_width=&#8221;0&#8243; link=&#8221;url:http%3A%2F%2Ftpm.bio%2Fen%2Flabs%2F|||&#8221;]BACK TO LABS[\/vc_button][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_height_percent=&#8221;0&#8243; back_color=&#8221;color-gyho&#8221; overlay_alpha=&#8221;50&#8243; 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