{"id":114359,"date":"2023-03-30T10:16:05","date_gmt":"2023-03-30T08:16:05","guid":{"rendered":"https:\/\/webserver.gfps.de\/physical-tests\/"},"modified":"2024-06-15T09:57:10","modified_gmt":"2024-06-15T07:57:10","slug":"physical-tests","status":"publish","type":"page","link":"https:\/\/www.gfps.de\/en\/physical-tests\/","title":{"rendered":"Physical tests"},"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;112483&#8243; back_position=&#8221;center center&#8221; overlay_color=&#8221;accent&#8221; 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; shape_bottom_h_use_pixel=&#8221;true&#8221; shape_bottom_height_percent=&#8221;100&#8243; shape_bottom_color=&#8221;accent&#8221; shape_bottom_opacity=&#8221;90&#8243; shape_bottom_index=&#8221;0&#8243; row_height_pixel=&#8221;280&#8243; row_name=&#8221;Intro&#8221; uncode_shortcode_id=&#8221;190119&#8243; back_color_type=&#8221;uncode-palette&#8221; shape_bottom_color_type=&#8221;uncode-palette&#8221; overlay_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_horizontal=&#8221;left&#8221; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#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; 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_speed=&#8221;1000&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;164002&#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;130954&#8243;]Visual inspection | Determination of peel characteristics | Testing for impermeability[\/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;136129&#8243;]Physical examinations[\/vc_custom_heading][\/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; style=&#8221;inherited&#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;322413&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_custom_heading 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;179069&#8243;]Testing of medical packaging[\/vc_custom_heading][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;159003&#8243; text_color_type=&#8221;uncode-palette&#8221;]<strong>Excerpt from the guideline DIN CEN ISO_TS 16775<\/strong><br \/>\nSterile barrier systems are designed to enable sterilization, provide physical protection, maintain the sterility of their contents to the point of use and enable aseptic delivery. Depending on the handling, transportation or storage conditions, a sterile barrier system can be combined with additional protective packaging to create a packaging system. ISO 11607-1 specifies requirements for materials, sterile barrier systems and packaging systems, including the validation of the design of a packaging system; ISO 11607-2, on the other hand, specifies requirements for the validation of packaging processes. The requirements set out in these standards are generic and apply to healthcare facilities and wherever medical devices are packaged and sterilized.[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][\/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;112482&#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_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;176664&#8243; back_color_type=&#8221;uncode-palette&#8221;][\/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;50&#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;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;dark&#8221; back_color=&#8221;accent&#8221; back_image=&#8221;112482&#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; align_medium=&#8221;align_center_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_center_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;800&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;192871&#8243; back_color_type=&#8221;uncode-palette&#8221;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-uydo&#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;400&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;112581&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading text_size=&#8221;h1&#8243; text_weight=&#8221;800&#8243; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;350079&#8243;]ENVIRONMENTAL SIMULATION \/ AGEING (shelf life)[\/vc_custom_heading][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;204033&#8243; text_color_type=&#8221;uncode-palette&#8221;]Environmental simulation includes test methods for investigating external environmental influences on packaging. The packaging is exposed to an aging process in constant heat in accelerated or real time and the effects of the environment with regard to performance, functional behavior and service life are determined.[\/vc_column_text][vc_separator sep_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;264971&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;111717&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;139853&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;321300&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Accelerated ageing (ASTM F1980)<\/li>\n<li>Real-time aging (ASTM F1980)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_button button_color=&#8221;accent&#8221; border_width=&#8221;0&#8243; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;194229&#8243; link=&#8221;url:https%3A%2F%2Fgfps.redesign-pg.de%2Fkontakt%2F|title:Contact%20us|&#8221;]Request a quote[\/vc_button][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-gyho&#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;600&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;179041&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h1&#8243; text_weight=&#8221;800&#8243; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;474482&#8243;]TRANSPORTSIMULATION (performance test\/qualification)[\/vc_custom_heading][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;621982&#8243; text_color_type=&#8221;uncode-palette&#8221;]Transport simulation includes test methods for examining external transport conditions on packaging. The packaging is subjected to vibration, impact and compression tests, tilt and drop tests and tensile strength tests to determine the effects of various freight, storage and transportation conditions.[\/vc_column_text][vc_separator sep_color=&#8221;color-xsdn&#8221; uncode_shortcode_id=&#8221;438336&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;111721&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;118724&#8243;][vc_single_image media=&#8221;111720&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;160604&#8243;][vc_single_image media=&#8221;111719&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;567050&#8243;][vc_single_image media=&#8221;111718&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;819512&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;556992&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Transport simulation (ASTM D4169)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_button button_color=&#8221;accent&#8221; border_width=&#8221;0&#8243; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;156864&#8243; link=&#8221;url:https%3A%2F%2Fgfps.redesign-pg.de%2Fkontakt%2F|title:Contact%20us|&#8221;]Request a quote[\/vc_button][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; 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;1\/4&#8243; uncode_shortcode_id=&#8221;119267&#8243; mobile_height=&#8221;360&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_size=&#8221;h1&#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;633972&#8243;]PACKAGING\/STERILE GOODS PACKAGING[\/vc_custom_heading][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;192861&#8243; text_color_type=&#8221;uncode-palette&#8221;]The primary objective of packaging systems for medical devices that are sterilized in the final packaging is to maintain sterility until use and for aseptic delivery to the patient (DIN EN ISO 11607-1). For this purpose, appropriate tests must be carried out, which ultimately enable the development and specification of packaging systems and medical devices.[\/vc_column_text][vc_separator sep_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;264971&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;111722&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;354276&#8243;][vc_column_text uncode_shortcode_id=&#8221;449514&#8243;]<strong>Test methods in packaging testing<\/strong>[\/vc_column_text][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;152441&#8243;]<strong>Checking the integrity of the sterile barrier system:<\/strong>[\/vc_column_text][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;128361&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Visual inspection (ASTM F1886 \/ F1886M)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111727&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;842098&#8243;][vc_single_image media=&#8221;111726&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;119723&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;214183&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Bubble test (ASTM F2096)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111725&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;173460&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;189784&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Testing for impermeability and continuity of the seal (ASTM F1929, ASTM F3039)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111724&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;443711&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;502743&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Testing for fine holes in the plastic composite film (DIN EN 868, Part 5)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111723&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;116956&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;119586&#8243; text_color_type=&#8221;uncode-palette&#8221;]<strong>Windability:<\/strong><\/p>\n<ul>\n<li>Determination of peel characteristics (peelability test DIN EN 868, part 5)<\/li>\n<li>Determination of the seal seam width (DIN EN 868, part 5)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111731&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;273556&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;185740&#8243; text_color_type=&#8221;uncode-palette&#8221;]<strong>Determination of the seal strength:<\/strong><\/p>\n<ul>\n<li>Tensile strength test of sealing seams (DIN EN 868, Part 5, ASTM F88)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111730&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;145809&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;311772&#8243; text_color_type=&#8221;uncode-palette&#8221;]<strong>Test for germ tightness:<\/strong><\/p>\n<ul>\n<li>Germ-tightness test (DIN 58953-6)<\/li>\n<li>With moisture:<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111729&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;727113&#8243;][vc_column_text text_lead=&#8221;yes&#8221; text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;108228&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>With air passage:<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_single_image media=&#8221;111728&#8243; media_width_percent=&#8221;100&#8243; media_ratio=&#8221;three-two&#8221; uncode_shortcode_id=&#8221;143898&#8243;][vc_column_text text_color=&#8221;color-wvjs&#8221; uncode_shortcode_id=&#8221;555736&#8243; text_color_type=&#8221;uncode-palette&#8221;]<\/p>\n<ul>\n<li>Microbial evaluation of porous packaging materials (ASTM F1608)<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_button button_color=&#8221;accent&#8221; border_width=&#8221;0&#8243; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;173108&#8243; 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[&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-114359","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Physical tests - GfPS<\/title>\n<meta name=\"description\" content=\"Sterile barrier systems are designed to enable sterilization, provide physical protection, maintain sterility, and ...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.gfps.de\/en\/physical-tests\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Physical tests - GfPS\" \/>\n<meta property=\"og:description\" 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