{"id":304,"date":"2025-07-02T16:30:35","date_gmt":"2025-07-02T16:30:35","guid":{"rendered":"https:\/\/www.cretexmedical.com\/qts\/?page_id=304"},"modified":"2025-08-27T20:23:31","modified_gmt":"2025-08-27T20:23:31","slug":"cleaning-passivation","status":"publish","type":"page","link":"https:\/\/www.cretexmedical.com\/qts\/services\/cleaning-passivation\/","title":{"rendered":"Cleaning &amp; Passivation"},"content":{"rendered":"[vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; top_padding=&#8221;6%&#8221; bottom_padding=&#8221;6%&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; enable_gradient=&#8221;true&#8221; color_overlay=&#8221;#0077c8&#8243; 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column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; el_class=&#8221;sidenav&#8221; advanced_gradient_angle=&#8221;0&#8243; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/4&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; gradient_type=&#8221;default&#8221;][vc_column_text el_class=&#8221;sticky-box&#8221;]<div class=\"menu-services-container\"><ul id=\"menu-services\" class=\"menu\"><li id=\"menu-item-298\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-298\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/\">QTS Services<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-322\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-322\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/project-management\/\">Project Management<\/a><\/li>\n\t<li id=\"menu-item-325\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-325\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/supply-chain-materials-management\/\">Supply Chain &amp; Materials Management<\/a><\/li>\n\t<li id=\"menu-item-321\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-321\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/package-development\/\">Package Development<\/a><\/li>\n\t<li id=\"menu-item-319\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-319\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/cleaning-passivation\/\">Cleaning &amp; Passivation<\/a><\/li>\n\t<li id=\"menu-item-317\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-317\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/assembly-kitting-packaging\/\">Assembly, Kitting &amp; Packaging<\/a><\/li>\n\t<li id=\"menu-item-328\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-328\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/label-development\/\">Label Development &amp; Printing<\/a><\/li>\n\t<li id=\"menu-item-320\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-320\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/engineering-inspection-validation-services\/\">Engineering, Inspection &amp; Validations<\/a><\/li>\n\t<li id=\"menu-item-324\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-324\"><a href=\"https:\/\/www.cretexmedical.com\/qts\/services\/sterilization-management\/\">Sterilization Management<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/div>[\/vc_column_text][\/vc_column][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/4&#8243; tablet_width_inherit=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_row_inner column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221; el_id=&#8221;component-molding&#8221;][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_custom_heading text=&#8221;Precision Cleaning Services to Support Quality from the Start&#8221; font_container=&#8221;tag:h3|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]At Cretex Medical | QTS we provide medical device cleaning and passivation services that ensure components meet your cleanliness requirements before they ever reach the cleanroom for assembly or packaging. We can either adopt your product into an existing cleaning process to optimize speed to market and validation costs, or our experts can design and validate customized cleaning processes tailored to your device materials, regulatory needs, and production timeline.[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color=&#8221;#e5f5fa&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; advanced_gradient_angle=&#8221;0&#8243; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/2&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; gradient_type=&#8221;default&#8221;][image_with_animation image_url=&#8221;361&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;Fade In&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][vc_column_text el_class=&#8221;txt-highlight&#8221;]Our teams can handle product line transfers or design a custom cleaning process for you.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;160&#8243;][vc_row_inner column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221; el_id=&#8221;component-molding&#8221;][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/3&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_custom_heading text=&#8221;Tailored Cleaning for Critical Components&#8221; font_container=&#8221;tag:h3|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]Our flexible approach to cleaning means we recommend the <strong>right method for your materials and product requirements<\/strong>, minimizing contamination to support regulatory compliance and product performance.<\/p>\n<p><strong>Our cleaning capabilities include:<\/strong><\/p>\n<ul>\n<li>Ultrapure DI (deionized) water systems<\/li>\n<li>Detergent cleaning with alkaline and neutral pH options<\/li>\n<li>Ultrasonic cleaning<\/li>\n<li>Automated equipment with continuous monitoring for temperature, conductivity, time, and agitation intensity<\/li>\n<li>Custom cleaning process design<\/li>\n<li>Isopropyl alcohol (IPA) wipe or dip<\/li>\n<li>Cleaning process validation studies<\/li>\n<li>Validations for product families<\/li>\n<\/ul>\n<p>Our cleaning services are <strong>performed entirely within an ISO class 8 cleanroom<\/strong>. Cleaned products are then transferred directly to the ISO Class 7 cleanroom <strong>without interim packaging or leaving the cleanroom environment.<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color=&#8221;#e5f5fa&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; advanced_gradient_angle=&#8221;0&#8243; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/3&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; gradient_type=&#8221;default&#8221;][image_with_animation image_url=&#8221;358&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;Fade In&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][vc_column_text el_class=&#8221;txt-highlight&#8221;]Seamless transfers between cleanroom environments increase the efficiency of the process.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;160&#8243;][vc_row_inner column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221; el_id=&#8221;molding-device-assembly&#8221;][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/3&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_custom_heading text=&#8221;Passivation Services&#8221; font_container=&#8221;tag:h3|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]For stainless steel and other corrosion-resistant components, we offer passivation services per <a href=\"https:\/\/www.cretexmedical.com\/qts\/regulatory-quality\/#procedural-guidelines\">ASTM A967 and ASTM F86 standards<\/a>. Our capabilities include:<\/p>\n<ul>\n<li><strong>Citric acid passivation<\/strong><\/li>\n<li><strong>Nitric acid passivation<\/strong><\/li>\n<\/ul>\n<p>Our team follows current industry best practices and regulatory guidance to ensure consistent, repeatable outcomes.<\/p>\n<p>Passivation can also be an effective bioburden and bacterial endotoxin reduction tool. When passivation and all downstream operations are performed in a controlled environment, this step can be effective in establishing control of bioburden prior to radiation sterilization, as required per <a href=\"https:\/\/www.cretexmedical.com\/qts\/regulatory-quality\/#procedural-guidelines\">ISO 11137-1<\/a>.[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color=&#8221;#e5f5fa&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; advanced_gradient_angle=&#8221;0&#8243; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/3&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; gradient_type=&#8221;default&#8221;][image_with_animation image_url=&#8221;359&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;Fade In&#8221; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;none&#8221; box_shadow=&#8221;none&#8221; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][vc_column_text el_class=&#8221;txt-highlight&#8221;]Our passivation techniques help extend the lifespan of your products.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][divider line_type=&#8221;Full Width Line&#8221; line_thickness=&#8221;1&#8243; divider_color=&#8221;default&#8221; custom_height=&#8221;160&#8243;][vc_row_inner column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221; el_id=&#8221;molding-device-assembly&#8221;][vc_column_inner column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_spacing=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/3&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_custom_heading text=&#8221;Collaborative Planning for Your Project&#8221; font_container=&#8221;tag:h3|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]Choosing the right cleaning and passivation methods, along with the appropriate testing, can be complex. 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