{"id":114260,"date":"2023-03-29T08:00:07","date_gmt":"2023-03-29T06:00:07","guid":{"rendered":"https:\/\/webserver.gfps.de\/sterility-test\/"},"modified":"2024-06-14T19:07:00","modified_gmt":"2024-06-14T17:07:00","slug":"sterility-test","status":"publish","type":"page","link":"https:\/\/www.gfps.de\/en\/sterility-test\/","title":{"rendered":"Sterility test"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;112464&#8243; back_position=&#8221;center center&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; 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animation_speed=&#8221;1000&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;151126&#8243;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h4&#8243; text_weight=&#8221;300&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-210350&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;144204&#8243;]Sterile products[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-155944&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;274936&#8243;]Sterility test[\/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;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; style=&#8221;inherited&#8221; uncode_shortcode_id=&#8221;106173&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-lxmt&#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; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;116340&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column_text uncode_shortcode_id=&#8221;174013&#8243;]Sterility testing is an important step in microbiological quality control in accordance with GMP (Good Manufacturing Practices) requirements.[\/vc_column_text][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;184491&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;55&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; inverted_device_order=&#8221;yes&#8221; style=&#8221;inherited&#8221; uncode_shortcode_id=&#8221;180067&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-xsdn&#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; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;200059&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading heading_semantic=&#8221;h4&#8243; text_size=&#8221;h4&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;936045&#8243;]Sterility tests[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;138715&#8243;]Sterility tests are used to ensure that sterile products do not contain viable microorganisms before they are released and administered to patients.<\/p>\n<p>It is recommended and required by the relevant standards to validate newly launched products by a method suitability test, especially if the product contains antimicrobial ingredients. This test is based on the selection of test samples that are considered the worst-case scenario in relation to the product being tested. After a five-day incubation to assess microbial growth, all microorganisms are considered detectable and validation is considered successful<\/p>\n<p>Our sterility tests are carried out in specially certified clean rooms that are certified in accordance with ISO standard 6.<\/p>\n<p>In the event of microbial growth during incubation, the microorganisms are differentiated directly to ensure that the sterility test can be evaluated.[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text uncode_shortcode_id=&#8221;161186&#8243;]<strong>Guidelines:<\/strong><\/p>\n<ul>\n<li>according to Ph. Eur. 2.6.1<\/li>\n<li>MST according to Ph.Eur. 2.6.1<\/li>\n<li>according to USP &lt;71&gt;<\/li>\n<li>MST according to USP &lt;71<\/li>\n<li>according to DIN EN ISO 11737-2<\/li>\n<li>MST according to DIN EN ISO 11373-2<\/li>\n<li>MST according to DIN EN ISO 11737-2<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text uncode_shortcode_id=&#8221;137226&#8243;]We will be happy to support you with your questions about sterility tests at <a href=\"mailto:freigabe@gfps.de\"><br \/>\n  <strong>freigabe@gfps.de<\/strong><br \/>\n<\/a>.<strong><br \/>\n<\/strong>[\/vc_column_text][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; back_color=&#8221;color-rgdb&#8221; back_image=&#8221;111838&#8243; back_position=&#8221;right center&#8221; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;183300&#8243; back_color_type=&#8221;uncode-palette&#8221; mobile_height=&#8221;300&#8243;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;112464&#8243; back_position=&#8221;center center&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-114260","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - 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